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The CIS Facility Study Register

The CIS Facility Study Register provides an easily accessible repository of meta-data concerning Robinson Research Institute affiliated longitudinal studies and clinical trials in the area of reproduction and paediatric health.

This register will support researchers to share knowledge and resources, align and enhance cohorts, and assist research collaboration, including pooled data. This resource will enable users get an overview of the reproductive and paediatric health research undertaken at the Robinson Research Institute.

Data Sharing

Through data sharing, researchers and policy makers can make the best use of new and existing data, increasing the cost effectiveness of data collection and improving policy decision-making outcomes. Data sharing also enables researchers to validate one another’s research outcomes and allows for the combination of data from multiple sources across states and organisations, encouraging novel and diverse explorations of data.

The CIS Facility has created a data-sharing recommendations document to identify questions researchers may need to consider to ensure data sharing is efficient, effective and secure. These considerations will form the basis of a mutually beneficial data sharing agreement.

Longitudinal studies
Study name Status Recruitment period Sample Recruitment locations
ENDIA: The Environmental Determinants of Islet Autoimmunity study Recruiting 2013 – current Target: 1400 participants Australia wide
Generation 1 Closed 1998-2000 557 children Women’s and Children’s Hospital, SA
Lyell McEwin Hospital, SA  
Private obstetrics services, SA
Lucina Closed 974 women South Australia
SAECDP: South Australia Early Childhood Data Project On-going SA population born 1999 - 2010 380,000 children South Australia
Clinical trials
Study name Status Recruitment period Sample Recruitment locations

FACT: Effect of folic acid supplementation in pregnancy on pre-eclampsia: Folic Acid Clinic Trial

Closed
FRUIT: Low molecular weight heparin (FRagmin) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia: a randomised trial Closed
GRoW: Metformin and dietary advice to improve insulin sensitivity and promote Gestational Restriction of Weight in pregnant women who are obese Closed 2013-2016 524 women Women’s and Children’s Hospital, SA
Lyell McEwin Hospital, SA
Flinders Medical Centre, SA
LIMIT: Limiting Weight Gain in Overweight and Obese Pregnant Women to Improve Pregnancy Outcomes: a randomised trial

Closed 2013-2016 2180 women Women’s and Children’s Hospital, SA
Lyell McEwin Hospital, SA
Modbury Hospital, SA
Flinders Medical Centre, SA
The MiG Trial: Metformin in Gestational Diabetes Closed
MiG:TOFU (2 years): Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin, 2 years Closed
MiG:TOFU (7-9 years): Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin, 7-9 years Closed
OPTIMISE: Optimising gestational weight gain and Improving Maternal and Infant health outcomes through antenatal dietary, lifestyle and Exercise advice Recruiting 2014 - current Target: 624 women Women’s and Children’s Hospital, SA
PAPO: Predicting Adverse Pregnancy Outcomes Study Closed 2008 - unknown 500 women Women’s and Children’s Hospital, SA
Lyell McEwin Hospital, SA
SCOPE: The Screening for Pregnancy Endpoints project Closed 2004 - 2014 5628 women Lyell McEwin Hospital, SA
STOP: Screening Tests to Predict poor Outcomes in Pregnancy Recruiting 2015 - current Target: 1350 women Women’s and Children’s Hospital, SA
Lyell McEwin Hospital, SA
TIPPS: Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women Closed
The TURRIFIC Study: Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy Not yet recruiting Anticipated Dec 2018-Dec 2021 Target: 108 women Women’s and Children’s Hospital, SA;
The Canberra Hospital, CBR;
King Edward Memorial Hospital, WA;
Royal North Shore Hospital, NSW;
Royal Hospital for Women, NSW;
Royal Brisbane & Women’s Hospital, QLD;
Mercy Hospital for Women, VIC;
Monash Medical Centre, VIC
TWINS: Timing of birth at term: a
randomised trial
Closed 2003 - 2010 235 women Women’s and Children’s Hospital, SA 
Lyell McEwin Hospital, SA
Royal Women's Hospital, VIC 
Mackay Base Hospital, QLD 
Townsville Hospital, QLD 
Caboolture Hospital, QLD 
Redcliffe Hospital, QLD 
John Hunter Hospital, NSW 
Logan Hospital, QLD 
Nepean Hospital, NSW 
The Mater Hospital, NSW 
Auckland Hospital, NZ 
Sant'Anna Hospital, Italy
WASH*T: Effect of Transfusion of Washed Red Blood Cells on Neonatal Outcome: A Randomised Controlled Trial Recruiting 2013 - current Target: 448 neonates Women’s and Children’s Hospital, SA
Flinders Medical Centre, SA
Mercy Hospital for Women, VIC
The Royal Women`s Hospital, VIC

Longitudinal studies
Study name Recruitment status Sample Pregnancy Infancy Childhood Adulthood Other family
ENDIA Recruiting Target: 1,400 participants  
Generation_1 Closed 557 children  
Lucina Closed 974 women      
SAECDP On-going 380,000 children      
Clinical trials
Study name Recruitment status Sample Pregnancy Infancy Childhood Adulthood Other family
FACT Closed 2,464 women
FRUIT Closed 154 women
GRoW Closed 524 women  
LIMIT Closed 2,180 women  
MiG Closed 751 women
MiG:TOFU2 Closed 323 children
MiG:TOFU7-9
Closed 208 children
OPTIMISE Closed Target: 624 women    
PAPO Closed Target: 700 women    
SCOPE Closed 5,628 women    
STOP Closed Target: 1,500 women    
TIPPS Closed 292 women
TURRIFIC
Yet to recruit
TWINS Closed 235 women    
WASH*T Closed Target: 448 neonates    

Longitudinal studies

  • ENDIA: The Environmental Determinants of Islet Autoimmunity study
    Study name The Environmental Determinants of Islet Autoimmunity study
    Study abbreviation ENDIA
    Recruitment status Recruiting
    Current principal investigator(s)

    Professor Jennifer Couper

    jennifer.couper@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre N/A
    Primary institution The University of Adelaide
    Collaborating institutions

    The University of Melbourne

    The University of Western Australia

    The University of Queensland

    The University of New South Wales

    The University of Sydney

    Participant recruitment site

    The Women’s and Children’s Hospital, SA

    The Princess Margaret Hospital, WA

    The Royal Melbourne Hospital, Vic

    The Monash Medical Centre, Vic

    The Barwon Health Geelong Hospital campus, Vic

    Mater Mother's Hospital, QL

    The Children's Hospital at Westmead, NSW

    The Royal Hospital for Women, NSW

    St George Hospital, NSW

    Study contact

    Dr Megan Penno

    megan.penno@adelaide.edu.au

    Contact
    megan.penno@adelaide.edu.au
    Trial registration number ACTRN12613000794707
    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources

    National Health and Medical Research Council

    The Leona M. and Harry B. Helmsley Charitable Trust

    JDRF

    Study website

    http://www.endia.org.au/

    https://www.facebook.com/endiastudy

    Are data available for sharing? See: http://www.endia.org.au/researcher-resources/
    Study background A longitudinal study of children with a first-degree relative with type 1 diabetes, followed prospectively from early pregnancy through childhood to investigate relationships between the development of islet autoimmunity (and subsequently type 1 diabetes) and prenatal and postnatal environmental factors.
    Study design Longitudinal, prospective

    Age of participants

    Pregnancy: T1, T2 and T3

    Infancy: Birth, 3, 6, 9, 12 months

    Childhood: 15, 18, 21, 24, 30, 36 months, onwards in 6 month intervals

    Other family: All first degree relatives

    Related documents available (data dictionaries, protocols, publications)? See: http://www.endia.org.au/researcher-resources/
    Sample (N) Target: 1400 participants
    Eligibility criteria

    Women recruited during pregnancy (>6wks) or child recruited as infant (<6months). All participants have a first-degree relative with type 1 diabetes.

    Pregnant women/primary caregivers unable to give informed consent were excluded.

    Participant recruitment period Feb 2013-Dec 2019
    Sociodemographic measures Ancestry, socioeconomic status, medical/obstetric history, lifestyle, sleep patterns, child feeding practices
    Child anthropomorphic measures Height, weight, length, BMI, waist circumference
    Mental health measures N/A
    Maternal clinical assessments Weight gain, physical activity, height, weight, length, BMI
    Child clinical assessments N/A
    Other domains N/A
    Imaging (ultrasound, etc) N/A
    Biosamples: cord blood Collected at birth
    Biosamples: vaginal/cervical swabs 3T
    Biosamples: bloods

    Mother: 3T, birth, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36 month PP

    Child: birth, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36 months

    Biosamples: urine

    Mother: 1T, 2T, 3T, birth, 3, 6, 9, 15, 21, 24, 30, 36 month PP

    Child: birth, 6, 12, 18, 24, 36 months

    Biosamples: faeces

    Mother: 1T, 2T, 3T, birth, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36 month PP

    Child: birth, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36 months

    Biosamples: saliva/baccal swab Mother, child, all first degree relatives: 3 months
    Other biological samples
    Colostrum, breast milk, body swabs
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics The ENDIA trial has been reviewed and approved by the Human Research Ethics Committees (HRECs) at all recruitment sites
  • Generation 1
    Study name

    Generation 1

    Study abbreviation Generation 1
    Recruitment status Closed
    Current principal investigator(s)

    Professor Vivienne Moore

    vivienne.moore@adelaide.edu.au

    Professor Michael Davies

    michael.davies@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre Life Course and Intergenerational Health (LIGHt) group
    Primary institution University of Adelaide
    Collaborating institutions
    Participant recruitment site

    Adelaide Women's and Children's Hospital

    Lyell McEwin Hospital Antenatal Clinic

    Two private obstetrics services

    Study Coordinator

    Dr Stephanie Champion

    stephanie.champion@adelaide.edu.au

    Study contact

    vivienne.moore@adelaide.edu.au

    Trial registration number
    Auxiliary studies All study follow-ups are collected under this study summary
    Trial registration of auxiliary studies N/A
    Funding sources
    Study website
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background Women were recruited into the study at ~16 weeks of pregnancy. Mother's with a live singleton baby were followed up during infancy and childhood. 
    Study design

    Prospective cohort study, observational

    Age of participants (across multiple follow-ups)

    Pregnancy: 3 and 8 months

    Infancy: Birth, 3, 6, 9, 12 months

    Childhood: 2, 3, 5, 9, 12 years

    Adulthood: planned 18 years

    Other family: Mother, primary carer

    Related documents available (data dictionaries, protocols, publications)?
    Sample (N) 557 children
    Eligibility criteria

    To be eligible to take part in the study a woman had to meet the following criteria: 1) Caucasian and aged at least 18 y old; 2) in the first 16 wk of a singleton pregnancy in which conception occurred without treatment for infertility; 3) planning to give birth in 1 of the 5 hospitals cooperating in the study; 4) not diabetic; 5) sufficiently fluent in English for completion of study questionnaires and able to give informed consent. Ethics approval was obtained from all hospitals cooperating in the study. Written consent was obtained from all participating women.

    Participant recruitment period 1998-2000
    Sociodemographic measures Parental employment, income, home ownership, house moves, relationship status and history.
    Child anthropomorphic measures

    Birth: length, weight

    6 months: length, weight, crown rump length, head/chest/abdomen/mid arm circumference, triceps and subscapular skin folds

    9 months: length, weight, crown rump length, head/chest/abdomen/mid arm circumference, triceps and subscapular skin folds

    1 year: length, weight, crown rump length, head/chest/abdomen/mid arm circumference, triceps and subscapular skin folds

    2 years: height (standing and sitting), weight, head/chest/abdomen/mid arm/mid calf circumference, triceps and subscapular skin folds

    3.5 years: height (standing and sitting), weight, body fat %, head/chest/abdomen/mid arm/mid calf circumference, triceps and subscapular skin folds, blood pressure

    9 years: height (standing and sitting), weight, body fat %, head/abdomen/hip/mid arm/mid calf circumference, triceps and subscapular skin folds, blood pressure, lung function (spirometry), sexual maturity rating (Tanner scale)

    12 years: height (standing and sitting), weight, body fat %, head/abdomen/hip/mid arm/mid calf circumference, blood pressure, sexual maturity rating (Tanner scale)

    Mental health measures

    The Center for Epidemiologic Studies Depression Scale (CES-D24) was used at 2 years and 3½ years interviews to define maternal depressive symptoms. Diagnosis of post-natal depression was recorded at the 2 and 3½ year interviews.

    The Spence Children's Anxiety Scale (SCAS), Gatehouse Bullying Scale, Psychological Sense of School Membership (PSSM) belonging subscale (8 items), Loneliness and Social Dissatisfaction Questionnaire, Short Mood and Feelings Questionnaire (SMFQ, Child Version) were measured at 9 years.

    Maternal clinical assessments

    Birth: labour events

    9 months: maternal weight

    1 year: maternal weight

    2 year: maternal weight

    3.5 years: Maternal height, weight, blood pressure, fat %

    9 years: Maternal height, weight, blood pressure, fat %

    12 years: Maternal height, weight, blood pressure, fat %

    Child clinical assessments

    5.5 years: dental health (linkage)

    9 years: DEXA body scan

    Other domains

    3 months: Child feeding and sleep, maternal and child illness, maternal employment

    6 months: maternal health and depression, employment, baby’s behaviour, social support, childcare arrangements, infant feeding, baby’s health and teeth growth

    9 months: Maternal health and depression, employment, baby’s behaviour, sleep, childcare arrangements, infant feeding, baby’s health and teeth growth

    1 year: Maternal health, baby’s behaviour, sleep, child care arrangements, infant feeding, baby’s health and teeth growth

    2 years: Maternal health and pregnancy, household members and relationships, employment and income, family wellbeing, child care, child’s health, injuries and medications, teeth growth

    3.5 years: Maternal health and pregnancy, household members and relationships, employment and income (mothers and partners), housing, family wellbeing, child care arrangements, child’s health, injuries and medications, dental health, family medical history

    5.5 years: Child’s health, injuries and medications, experiences in starting school, household members and relationships, employment and income (mothers and partners), maternal health and pregnancy, parenting problems, child behaviour

    9 years: Maternal health, depression and pregnancies, household members and relationships, employment and income (mothers and partners), housing, child’s health, injuries, dental, and medications, child education, sleep and screen time, child care and family activities, mother’s views on food and eating habits, life stressors, relationships and parenting roles, child behaviour, happiness and diet (food frequency)

    12 years: Maternal health, depression and pregnancies, household members and relationships, employment and income (mothers and partners), housing, child’s health, injuries, dental, and medications, child education, sleep and screen time, child care and family activities, mother’s views on food and eating habits, life stressors, relationships and parenting roles, child behaviour, friendships and happiness, and drug/alcohol experiences

    Imaging (ultrasound, etc) 9 years: DEXA body scan
    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods 9 years
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosample: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? NAPLAN, Dental health
    Ethics
  • Lucina
    Study name The Lucina Study
    Study abbreviation Lucina
    Recruitment status Wave 1 Closed
    Current principal investigator(s)

    Professor Michael Davies

    michael.davies@adelaide.edu.au

    Professor Vivienne Moore

    vivienne.moore@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre Life Course and Intergenerational Health (LIGHt) group
    Primary institution The University of Adelaide
    Collaborating institutions The Queen Elizabeth Hospital, Adelaide, South Australia
    Participant recruitment site South Australia
    Study Coordinator

    Kendall Smith

    Nanette Kretschmer

    Study contact

    Dr Jodie Avery

    jodie.avery@adelaide.edu.au

    Trial registration number
    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources National Health and Medical Research Council of Australia (NHMRC) Strategic Award No. 465455.
    Study website N/A
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background

    Polycystic ovary syndrome (PCOS) is considered to be the most common endocrine disorder in women of reproductive age, yet debate over appropriate diagnostic criteria and design limitations with sampling methodology have left some doubt as to the actual prevalence
    in the community.

    The objective of this study was to create a representative prevalence estimate of PCOS in the community under the National Institutes of Health (NIH) criteria and the more recent Rotterdam consensus criteria and Androgen Excess Society (AES) criteria.

    A retrospective birth cohort study was carried out in which 728 women born during 1973–1975 in a single maternity hospital were traced and interviewed in adulthood (age = 27–34 year; n =728). Symptoms of PCOS (hyperandrogenism, menstrual dysfunction and polycystic ovaries) were identified by examination and the presence of polycystic ovaries in those that did not consent to the ultrasound were imputed.

    Study design Retrospective birth cohort study
    Age of participants
    Wave 1: 30 to 34 years
    Related documents available (data dictionaries, protocols, publications)?

    Publications:

    2010

    March WA, Moore VM, Willson KJ , Phillips DIW, Norman RJ, and Davies MJ. (2010) The prevalence of polycystic ovary syndrome in a community sample assessed under contrasting diagnostic criteria

    2011

    Davies MJ, Marino JL, Willson KJ, March WA, Moore VM (2011) Intergenerational Associations of Chronic Disease and Polycystic Ovary Syndrome

    2012

    Davies MJ, March WA, Willson KJ, Giles LC, Moore VM (2012) Birthweight and thinness at birth independently predict symptoms of polycystic ovary syndrome in adulthood

    2015

    Moran LJ, March WA, Whitrow MJ, Giles LC, Davies MJ, and Moore VM (2015) Sleep disturbances in a community based sample of women with polycystic ovary syndrome

    2018

    March WA, Whitrow MJ, Davies MJ, Fernandez RC, Moore VM (2018) Postnatal depression in a community-based study of women with polycystic ovary syndrome

    Sample (N) 974 women
    Eligibility criteria

    Women born and discharged between January 1973–December 1975 at The Queen Elizabeth Hospital

    Deceased or disabled babies were not included

    Participant recruitment period Wave 1: 2003-2007
    Sociodemographic measures Marital status, living arrangements, occupation, travel history, house moves, relationships, family health, education, employment history, income, partnering, property ownership, social security, financial issues and debt, health status, history and childbearing, infertility and contraception, health behaviours, religion
    Child anthropomorphic measures

    Original participant child:

    Birth weight (g)

    Length (cm)

    Ponderal Index (kg/m3)

    Placental weight (g)

    Mental health measures

    Life Satisfaction questionnaire

    Short Form 12 questionnaire

    The Center for Epidemiological Studies Depression Scale (CES-D)

    Maternal clinical assessments N/A
    Child clinical assessments N/A
    Other domains

    Physical activity

    Sleep

    Medications

    Chronic conditions

    Recreational drug use

    Modified Ferriman-Gallwey (mF-G) for clinical hirsutism

    Modified Jenkins Sleep Questionnaire

    Imaging (ultrasound, etc) 108 (39.0%) women consented to a vaginal ultrasound of the ovaries
    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods Serum TSH, prolactin and 17-hydroxyprogesterone levels, SBHG
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics The University of Adelaide (Approved: March 2000, H/36/99)
  • SAECDP: South Australia Early Childhood Data Project
    Study name South Australia Early Childhood Data Project
    Study abbreviation SAECDP
    Recruitment status On-going
    Current principal investigator(s)

    Professor John Lynch

    john.lynch@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre BetterStart Child Health and Development Research Group
    Primary institution The University of Adelaide
    Collaborating institutions Government of South Australia Dept for Education and Child Development, Department of the Premier and Cabinet, SA Health
    Participant recruitment site N/A
    Study Coordinator N/A
    Study contact
    Trial registration number N/A
    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources

    National Health and Medical Research Council (NHMRC)

    Study website https://aifs.gov.au/cfca/pacra/south-australian-early-childhood-data-project
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background


    The South Australian Early Childhood Data Project links routinely collected data from approximately 20 government health, education and welfare service sources with the goal of improving services, supporting healthy child development, and improving outcomes for disadvantaged children.

    Study design Prospective
    Age of participants
    Birth to 12 months, 1-26 years
    Related documents available (data dictionaries, protocols)? N/A
    Sample (N) 480,000 children
    Eligibility criteria All children born in South Australia (SA) from 1991 to 2015
    Participant recruitment period 1991-2015
    Sociodemographic measures Education, occupation, SEIFA, employment
    Child anthropomorphic measures 4 year old health check - CaFHS
    Mental health measures

    Edinburgh Postnatal Depression Scale

    Postnatal Risk Questionnaire

    Maternal clinical assessments N/A
    Child clinical assessments

    Immunisations

    Neonatal Hearing Screen

    Brief Response

    1-4 week, 6-8 week, 6 month, 18-24 month, 4 year Health Checks

    Patient Services Data

    Dental health

    Hospital admissions and emergency presentation

    Perinatal, congenital abnormalities, births and deaths register

    Other domains

    Family Home Visiting

    Pathways to parenting

    Education records (preschool cencus, SACE, public school enrollment, reading at yr 1 and 2, NAPLAN at year 3, 5, 7, and 9, English as an additional language, SATAC)

    Child protection

    Public housing

    Youth justice

    Imaging (ultrasound, etc) N/A
    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods N/A
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? SA police, DASSA, CAMHS, Families SA
    Ethics

Clinical trials

  • FACT: Effect of folic acid supplementation in pregnancy on pre-eclampsia: Folic Acid Clinic Trial
    Study name Effect of folic acid supplementation in pregnancy on pre-eclampsia - Folic Acid Clinic Trial
    Study abbreviation FACT
    Recruitment status Completed
    Current principal investigator(s)

    Shi Wu Wen, Ottawa Hospital Research Institute, Canada swwen@ohri.ca

    Dr Mark Walker, Ottawa Hospital Research Institute, Canada mwalker@toh.ca

    Australian investigator : Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre

    Ottawa Hospital Research Institute

    Primary institution University of Ottawa
    Collaborating institutions
    Participant recruitment site

    Multiple recruitment sites in Canada, Australia, Argentina, Jamaica and the United Kingdom

    Hospital Provincial, Sante Fe, Rosario, Argentina

    Hospital Roque Saenz Penia, Sante Fe, Rosario, Argentina

    Maternidad Martin, Sante Fe, Rosario, Argentina

    Sanatorio de la Mujer, Sante Fe, Rosario, Argentina

    Hospital Escuela Eva Perón, Rosario, Santa Fe, Argentina, S2000DKR

    Cemic, Buenos Aires, Argentina

    Hospital Cullen, Sante Fe, Argentina

    Hosptial Iturraspe, Sante Fe, Argentina

    Nepean, Penrith, New South Wales, Australia, 2750

    Townsville, Douglas, Queensland, Australia, 4814

    Ipswich, Ipswich, Queensland, Australia, 4305

    Adelaide, North Adelaide, South Australia, Australia, 5006

    Royal Women's Hospital, Parkville, Victoria, Australia, 3052

    Sunshine, St Albans, Victoria, Australia, 3021

    Calgary Foothills Medical Center, Calgary, Alberta, Canada, T2N2T9

    Edmonton Lois Hole Hospital for Women, Edmonton, Alberta, Canada, T5H 3V9

    Canada, British Columbia, Vancouver BC Women's Hospital and Health Center, Vancouver, British Columbia, Canada, V5Z 4H4

    St-Paul's Hospital, Vancouver, British Columbia, Canada, V6Z 2K5

    Fredericton Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick, Canada, E3B 5N5

    Moncton Hospital, Moncton, New Brunswick, Canada, E1C 6Z8

    Saint John Regional Hospital, Saint John, New Brunswick, Canada, E2L 4L2

    Winnipeg St. Boniface General Hospital, Winnipeg, New Brunswick, Canada, R2H 2A6

    Winnipeg University of Manitoba, Winnipeg, New Brunswick, Canada, R3E 3P4

    St-John's Women's Health Centre, St John's, Newfoundland and Labrador, Canada, A1B 3V6

    Hamilton McMaster University, Hamilton, Ontario, Canada, L8S 4K1

    Kingston, Kingston, Ontario, Canada, K7L 2V7

    London, London, Ontario, Canada, N6A 5W9

    Ottawa Hospital, Ottawa, Ontario, Canada, K1H 8L6

    Civic Hospital, Ottawa, Ontario, Canada, K1Y 4E9

    Sault Ste- Marie Sault Area Hospital, Sault Ste. Marie, Ontario, Canada, P6B 0A8

    Sunnybrook Health Sciences, Toronto, Ontario, Canada, M4N 3M5

    Quebec City (CHUL) Centre Hospitalier Universitaire, Montreal, Quebec, Canada, G1V 4G2

    Saint-Luc CHUM – Montreal, Montreal, Quebec, Canada, H2X 3J4

    McGill University Royal Victoria Hospital, Montreal, Quebec, Canada, H3A 1A1

    Sainte-Justine, Montreal, Quebec, Canada, H3T 1C5

    Regina Qu'Appelle Health Region, Regina, Saskatchewan, Canada, S4P 0W5

    University of West Indies, Kingston 7, Jamaica

    Jubilee, Kingston, Jamaica

    Spanishtown, Kingston, Jamaica

    Hinchingbrooke, Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT

    Warrington and Halton Hospitals NHS Foundation Trust, Warrington, Cheshire, United Kingdom, WA51QC

    Darlington Memorial Hospital, Darlington, County Durham, United Kingdom, DL3 6HX

    University Hospital of North Durham, Durham, County Durham, United Kingdom, DH1 5TW

    Cumberland Infirmary, Carlisle, Cumbria, United Kingdom, CA27HY

    West Cumberland Hospital, Whitehaven, Cumbria, United Kingdom, CA288JG

    Fairfield, Bury, Lancashire, United Kingdom, BL9 7TD

    Rochdale, Rochdale, Lancashire, United Kingdom, OL12 0NB

    Lincolnshire, Lincoln, Lincolnshire, United Kingdom, LN2 4AX

    Ormskirk, Southport, Merseyside, United Kingdom, PR8 6PN

    Northwick Park Hospital, Harrow, Middlesex, United Kingdom, HA1 3UJ

    West Middlesex University Hospital, Isleworth, Middlesex, United Kingdom, TW7 6AF

    49 Marine Avenue & CCGs, Whitley Bay, Newcastle upon Tyne, United Kingdom, NE13 9BA

    Wansbeck General Hospital, Ashington, Northumberland, United Kingdom, NE63 9JJ

    St George's Hospital, London, Tooting, United Kingdom, SW17 0QT

    Gateshead Queen Elizabeth Hospital, Gateshead, Tyne and Wear, United Kingdom, NE9 6SX

    South Tyneside Distrcit Hospital, South Shields, Tyne and Wear, United Kingdom, NE34 0PL

    The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, West Midlands, United Kingdom, WV100QP

    Blackburn, Blackburn, United Kingdom, BB2 3HH

    Burnley, Burnley, United Kingdom, BB10 2PQ

    North Manchester, Crumpsall, United Kingdom, M8 5RB

    Guy's & St Thomas' Hospital, London, United Kingdom, SE1 9RT

    South Tees Hospital, Middlesbrough, United Kingdom, TS4 3BW

    Newcastle upon Tyne Hospitals, Newcastle upon Tyne, United Kingdom, NE1 4LP

    North Tyneside General Hospital, North Shields, United Kingdom, NE29 8NH

    Norfolk & Norwich, Norwich, United Kingdom, NR4 7UY

    Nottingham City Hospital, Nottingham, United Kingdom, NG5 1PB

    Nottingham Queens Medical Centre, Nottingham, United Kingdom, NG7 2UH

    Oldham, Oldham, United Kingdom, OL1 2JH

    North Tees Hospital, Stockton, United Kingdom, TS19 9AH

    Sunderland Royal Hospital, Sunderland, United Kingdom, SR4 7TP

    Hillingdon Hospital, Uxbridge, United Kingdom, UB8 3NN

    Study Coordinator

    Dr Suzette Coat

    suzette.coat@adelaide.edu.au

    Study contact

    Dr Shi Wu Wen

    swwen@ohri.ca

    Trial registration number

    ClinicalTrials.gov number: NCT01355159

    International Standard Randomised Controlled Trial Number: ISRCTN23781770

    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources Canadian Institutes of Health Research (CIHR)
    Study website N/A
    Are data available for sharing? Contact the principle investigator for information
    Study background Investigating if a high dose (4.0 mg per day) supplementation for pregnant women at high risk of developing preeclampsia starting in early pregnancy and continued throughout the entire pregnancy will lower the incidence of preeclampsia
    Study design

    Intervention

    Randomised control trial

    Age of participants
    18 years and older
    Related documents available (data dictionaries, protocols)? Wen SW, Champagne J, Rennicks White R, Coyle D, Fraser W, Smith G, Fergusson D, Walker MC. Effect of folic acid supplementation in pregnancy on preeclampsia: the folic acid clinical trial study. Journal of pregnancy. 2013;2013
    Sample (N) International: 2,464 women
    Eligibility criteria

    Pregnant women between 8-16 weeks of gestation, aged 18 or over, taking 1.1 mg or less of folic acid supplementation and diagnosed with at least one risk factors for pre-eclampsia (pre-existing high blood pressure, pre-pregnancy diabetes, twin pregnancy, a history of PE in a previous pregnancy or a BMI 35 kg/m2 or over within 3 months prior to current pregnancy or up to joining the study)

    Women who had a known history of disease or conditions that would contraindicate folic acid supplementation, a history of fetal anomaly or demise, renal disease, epilepsy, cancer, using folic acid antagonists, participating in another trial with a drug intervention, a history of drug or alcohol abuse, a sensitivity to folic acid, a multiple pregnancy (triplets or more) or previously participated in the FACT study were excluded

    Participant recruitment period April 2011-November 2015
    Sociodemographic measures
    Child anthropomorphic measures
    Mental health measures
    Maternal clinical assessments

    Recruitment (8-16 weeks gestation): systolic and diastolic blood pressure, weight

    24-26 weeks gestation: systolic and diastolic blood pressure, weight

    34-36 weeks gestation: systolic and diastolic blood pressure, weight

    Time of birth: systolic and diastolic blood pressure, weight

    42 days post gestation (phone interview):

    Child clinical assessments
    Other domains
    Imaging (ultrasound, etc)
    Biosamples: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods
    Biosamples: urine Collected at recruitment (8-16 weeks gestation), 24-26 weeks gestation, 34-36 weeks gestation
    Biosamples: faeces
    Biosamples: saliva/baccal swab
    Other biological samples
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics Ottawa Hospital Research Ethics Board, 14/10/2010
  • FRUIT: Low molecular weight heparin (FRagmin) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia: a randomised trial
    Study name Low molecular weight heparin (FRagmin) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia: a randomised trial
    Study abbreviation FRUIT study
    Recruitment status Completed
    Current principal investigator(s)

    Professor J.I.P. de Vries JIP.deVries@VUMC.nl

    Previous principal investigator(s) N/A
    Research centre
    Primary institution Vrije Universiteit University Medical Center (Netherlands)
    Collaborating institutions The University of Adelaide
    Participant recruitment site Eleven university hospitals (8 in Netherlands, 2 in Australia, 1 in Sweden), six non‐university/teaching hospitals in the Netherlands
    Study Coordinator N/A
    Study contact

    Professor J.I.P. de Vries JIP.deVries@VUMC.nl

    Trial registration number

    International register ISRCTN87325378

    Netherlands Trial Register NTR337

    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources Pharmacia & Upjohn Company (The Netherlands)
    Study website http://www.vumc.nl/zorg/ 
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background Investigation to determine if low molecular weight heparin plus aspirin reduces the recurrence of preeclampsia and/or small for gestational age infants before 34 weeks gestational age in women with documented thrombophilia with a history of preeclampsia and/or small for gestational age infants with birth before 34 weeks
    Study design

    Randomised control trial

    Intervention

    Age of participants
    18 years and older
    Related documents available (data dictionaries, protocols)? de Vries JI, van Pampus MG, Hague WM, Bezemer PD, Joosten JH, , Low-molecular-weight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia: the FRUIT-RCT., J. Thromb. Haemost., 2012, 10, 1, 64-72, doi: 10.1111/j.1538-7836.2011.04553.x.
    Sample (N) 154 women
    Eligibility criteria

    Women, aged 18 years and older, less than 12 weeks gestation at recruitment, with a history of preeclampsia and/or delivery of small for gestational age infants before 34 weeks gestation, and documented thrombophilia restricted to protein C and protein S deficiency, Activated Protein C (APC) resistance, Factor V Leiden mutation, Factor II mutation, anticardiolipin antibodies, lupus anticoagulant, and able to give informed consent

    Women with the following conditions were excluded: antithrombin deficiency, diabetes mellitus, known malignancy, gastro-duodenic ulcer, severe renal or hepatic insufficiency, thrombo-embolism in history, hemorrhagic diathesis, or idiopathic thrombocytopenia

    Participant recruitment period Dec 2000-Dec 2009
    Sociodemographic measures Trial entry: baseline demographic (smoking, ethnicity, age, partnering), obstetric data, family history of arterial and/or venous disease, pre‐eclampsia
    Child anthropomorphic measures
    Mental health measures
    Maternal clinical assessments Recruitment: blood pressure, weight, BMI
    Child clinical assessments
    Other domains
    Imaging (ultrasound, etc) Recruitment: sonographic confirmation of a viable intrauterine pregnancy
    Biosamples: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods Collected twice, 10 weeks postpartum (at least), and ≥ 6 weeks after the first test: thrombophilia status, methionine loading test (MLT)
    Biosamples: urine Collected from women
    Biosamples: faeces
    Biosamples: saliva/baccal swab
    Other biological samples
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics Approved by the medical ethical committees of all participating hospitals
  • GRoW: Metformin and dietary advice to improve insulin sensitivity and promote Gestational Restriction of Weight in pregnant women who are obese
    Study name Metformin and dietary advice to improve insulin sensitivity and promote Gestational Restriction of Weight in pregnant women who are obese
    Study abbreviation the GroW Randomised trial
    Recruitment status Closed
    Current principal investigator(s)

    Professor Jodie Dodd

    jodie.dodd@adelaide.edu.au

    Dr Rosalie Grivell

    rosalie.grivell@adelaide.edu.au

    Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre Australian Research Centre for the Health of Women & Babies
    Primary institution The University of Adelaide
    Collaborating institutions N/A
    Participant recruitment site

    The Womens and Childrens Hospital, North Adelaide

    The Lyell McEwin Hospital, Elizabeth Vale

    Flinders Medical Centre, Bedford Park

    Modbury Hospital, Modbury

    Study Coordinator

    Andrea Deussen

    andrea.deussen@adelaide.edu.au

    Study contact jodie.dodd@adelaide.edu.au
    Trial registration number ACTRN12612001277831
    Auxiliary studies All study follow-ups are collected under this trial summary
    Trial registration of auxiliary studies N/A
    Funding sources National Health and Medical Research Council (NHMRC)
    Study website N/A
    Are data available for sharing? Applications in writing to Jodie Dodd
    Study background

    To evaluate the efficacy of metformin and dietary and lifestyle advice in reducing insulin sensitivity in obese pregnant women and improving pregnancy and birth outcomes including the incidence of infants born with birth weight greater than 4 kg. Obese women are at an increased risk of a range of complications during pregnancy, and their offspring may experience an increased risk of overweight or obese in childhood, diabetes and heart disease in later life.This double blind placebo controlled trial randomly allocated overweight/obese women to receive metformin or a placebo to determine if metformin modifies the risk of women becoming insulin resistant or developing gestational diabetes. All women received dietary and exercise advice throughout their pregnancy.

    Study design Randomised control trial
    Age of participants (across multiple follow-ups)

    Mothers, offspring and partners

    Pregnancy: <20, 28, 36 weeks

    Infancy: 6 months

    Childhood: 18 months, 3 years

    Related documents available (data dictionaries, protocols)?
    Sample (N) 524 women
    Eligibility criteria

    Women with a singleton, live gestation between 10 +0 and 20 +0 weeks gestation with a BMI above or equal to 25 kg/m2 at their first antenatal visit. Women with a multiple pregnancy, type 1 or 2 diabetes

    Women diagnosed prior to pregnancy, known renal or hepatic failure were excluded

    Participant recruitment period June 2013 - April 2016
    Sociodemographic measures Trial entry: SES assessed by residential postcode, level of education, born in Australia/length of Australian residency
    Child anthropomorphic measures At birth, 6 months and 18-24 months: height, weight and anthropometry
    Mental health measures

    Trial entry: Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI)

    28 weeks gestation: Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI)

    36 weeks gestation: Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI)

    4 months postpartum: The Ages and Stages Questionnaire (ASQ)

    18-24 months: The Ages and Stages Questionnaire (ASQ)

    Maternal clinical assessments Maternal anthropometry trial entry and 36 weeks. Height, weight and blood pressure at 3 years postpartum. Maternal adverse outcomes during labour
    Child clinical assessments

    Birth: Birth case notes, weight, length and blood pressure

    6 months and 18 months: Weight, length and blood pressure

    Other domains

    18-24 months: Child feeding questionnaire

    Partners of recruited women were also followed

    Metabolic, cytokines, hormones genetic and epigenetic studies planned. Metabolic studies planned

    Imaging (Ultrasound, etc) N/A
    Biosamples: cord blood Cord blood
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods Trial entry, 28 and 36 weeks gestation: Maternal plasma
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab Birth, 6 months postpartum and 18-24 months: Paternal saliva and infant saliva at birth
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics Women’s and Children’s Health Network Human Research Ethics Committee (HREC/12/WCHN/114)
  • LIMIT: Limiting Weight Gain in Overweight and Obese Pregnant Women to Improve Pregnancy Outcomes: a randomised trial
    Study name Limiting Weight Gain in Overweight and Obese Pregnant Women to Improve Pregnancy Outcomes: a randomised trial
    Study abbreviation LIMIT
    Recruitment status Closed
    Current principal investigator(s)

    Professor Jodie Dodd

    jodie.dodd@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre Australian Research Centre for the Health of Women & Babies
    Primary institution The University of Adelaide
    Collaborating institutions N/A
    Participant recruitment site

    The Womens and Childrens Hospital, North Adelaide

    The Lyell McEwin Hospital, Elizabeth Vale

    Flinders Medical Centre, Bedford Park

    Modbury Hospital, Modbury

    Study Coordinator

    Andrea Deussen

    andrea.deussen@adelaide.edu.au

    Study contact jodie.dodd@adelaide.edu.au
    Trial registration number ACTRN12607000161426
    Auxiliary studies All study follow-ups are collected under this trial summary
    Trial registration of auxiliary studies N/A
    Funding sources

    National Health and Medical Research Council (NHMRC)

    National Institutes of Health (NIH)

    Channel 7 Research Foundation

    Clive and Vera Ramaciotti Foundation

    Study website N/A
    Are data available for sharing? Applications in writing to Jodie Dodd
    Study background/objectives To assess whether implementation of a package of dietary and lifestyle advice to overweight and obese pregnant women is effective in improving maternal, and infant health outcomes
    Study design

    Randomised controlled trial

    Intervention study, dietary and lifestyle advice

    Age of participants (across multiple follow ups)

    Mothers, offspring and partners

    Pregnancy: 28, 36 weeks

    Infancy: 4-6 months (n=1562)

    Childhood: 18 months (n=1350), 3 years (n=550)

    Related documents available (data dictionaries, protocols)?
    Sample (N) 2180 women
    Eligibility criteria

    Overweight and obese women (as defined by a BMI equal to or greater than 25kg/m2, or equal to or greater than 30kg/m2) at trial entry, with a singleton pregnancy between 10 and 25 week's gestation

    Women with a multiple pregnancy, or type two diabetes or gestational diabetes diagnosed before trial entry were excluded

    Participant recruitment period
    Sociodemographic measures Trial entry: SES assessed by residential postcode
    Child anthropomorphic measures Birth, 6 months postpartum, 18 months and 3 years: height, weight and anthropometry
    Mental health measures

    Trial entry: Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI)

    28 weeks gestation: Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI)

    36 weeks gestation: Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI)

    4-6 months postpartum: (mother) Edinburgh postnatal depression scale, Short Form Survey Instrument (SF-36), The State-Trait Anxiety Inventory (STAI), (infant) The Ages and Stages Questionnaire (ASQ)

    18 months: (Infant) The Ages and Stages Questionnaire (ASQ)

    3 years: Anxiety and depression checklist (K10), The 12-Item Short Form Health Survey (SF-12), (child) The Ages and Stages Questionnaire (ASQ)

    Maternal clinical assessments

    Trial entry and 36 weeks gestation: maternal anthropometry

    3 years postpartum: height, weight and blood pressure

    Child clinical assessments N/A
    Other domains

    18 months and 3 years: child feeding questionnaire

    Metabolic, cytokines, hormones genetic and epigenetic staudies planned. Metabolomic studies planned

    Imaging (Ultrasound, etc) N/A
    Biosamples: cord blood Cord blood collected
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods Trial entry, 28 and 36 week's gestation: maternal plasma
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab Birth, 6 months postpartum, 18 months and 3 years: paternal saliva and infant saliva
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A  
    Ethics

    Women's & Children's Hospital Network Human Research Ethics Committee (Ref: EC00197) LIMIT RCT (1839/6/15, first approved June 2007)

    Ancillary Studies (2051/4/14, first approved April 2009); FMC HREC (128/08 August 2008); TQEH HREC (2008003, April 2008)

    LIMIT 3 Yr Follow up (2476/05/15, first approved August 2012)

  • The MiG Trial: Metformin in Gestational Diabetes
    Study name Metformin in Gestational Diabetes
    Study abbreviation The MiG trial
    Recruitment status Closed
    Current principal investigator(s)

    New Zealand: Dr Janet Rowan, National Women's Health, Auckland, New Zealand

    jrowan@internet.co.nz

     

    Australia: Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre N/A
    Primary institution National Women's Health, Auckland, New Zealand
    Collaborating institutions The University of Adelaide
    Participant recruitment site 10 New Zealand and Australian urban obstetrical hospitals
    Study Coordinator

    Dr Suzette Coat

    suzette.coat@adelaide.edu.au

    Study contact

    Dr Janet Rowan

    jrowan@internet.co.nz

    Trial registration number ACTRN12605000266662
    Auxiliary studies Yes -follow-up studies are listed separately 
    Trial registration of auxiliary studies ACTRN12605000311651
    Funding sources

    Human Research Council (New Zealand)

    National Human Medical Research Council

    Auckland Medical Research Foundation

    National Women's Health (New Zealand)

    Study website N/A
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background Investigation to determine if metformin improved markers of insulin sensitivity in mothers and offspring (compared to insulin), and demonstrates improved treatment acceptability
    Study design

    Randomised control trial

    Intervention

    Age of participants
    18-45 years
    Related documents available (data dictionaries, protocols)? Rowan JA. A trial in progress: gestational diabetes: treatment with metformin compared with insulin (the Metformin in Gestational Diabetes [MiG] trial). Diabetes Care. 2007 Jul 1;30(Supplement 2):S214-9.
    Sample (N) 751 women
    Eligibility criteria

    Women, 20-33 weeks' gestation, singleton pregnancy, and capillary glucose levels requiring additional treatment (fasting glucose >5.4 mmol/l or 2 hour postprandial glucose in >6.7 mmol/l) were included

    Women who were diagnosed with diabetes prior to pregnancy, gestational hypertension, pre-eclampsia of fetal growth restriction at study entry, fetal congenital anomaly, or a medical condition posing contraindication to metformin were excluded

    Participant recruitment period October 2002 and November 2006
    Sociodemographic measures

    Recruitment: maternal demographic data, medical history, family history, obstetric history, medication intake through pregnancy, early pregnancy data, pregnancy complications

    Within one week of birth: Acceptability of treatments (unnamed questionnaire)

    6–8 weeks postpartum: maternal medication intake, infant health, infant feeding behaviours (unnamed questionnaire). Contact details confirmed/consent for follow-up study

    Child anthropomorphic measures

    Birth: crown heel and crown rump lengths, head, mid–upper arm, chest, and waist circumference, subscapular and triceps skinfold thickness, birth-weight percentiles

    6–8 weeks postpartum: height and weight

    Mental health measures N/A
    Maternal clinical assessments

    Recruitment: Height, weight, blood pressure

    Birth: mode of delivery and complications

    6–8 weeks postpartum: weight, blood pressure

    Child clinical assessments

    Birth: blood pressure, 5-minute Apgar score

    6–8 weeks postpartum: blood pressure

    Other domains Recruitment: paternal demographic data, height and weight
    Imaging (ultrasound, etc) Recruitment (-2 weeks to +1week) and 36-37 weeks gestation: Fetal ultrasound growth is documented
    Biosamples: cord blood Birth: cord blood collected and assessed for insulin, markers of the adipoinsular axis, blood glucose levels measured within 2 hours after birth
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods

    Recruitment: fasting bloods, glucose and liver function

    36-37 weeks gestation: fasting maternal blood samples (A1C, glucose, and lipids)

    6–8 weeks postpartum: fasting triglyceride levels

    Biosamples: urine 36-37 weeks gestation: urine albumin-to-creatinine ratio
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab 6–8 weeks postpartum: oral glucose tolerance test
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics Approval has been granted from all participating sites
  • MiG:TOFU (2 years): Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin, 2 years
    Study name Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin
    Study abbreviation MiG:TOFU (2 years)
    Recruitment status Closed
    Current principal investigator(s)

    New Zealand: Dr Janet Rowan, National Women's Health, Auckland, New Zealand

    jrowan@internet.co.nz

     

    Australia: Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre N/A
    Primary institution National Women's Health, Auckland, New Zealand
    Collaborating institutions The University of Adelaide
    Participant recruitment site

    Auckland, New Zealand

    Adelaide, Australia

    Study Coordinator

    Dr Suzette Coat

    suzette.coat@adelaide.edu.au

    Contact details

    Dr Janet Rowan

    jrowan@internet.co.nz

    Trial registration number ACTRN12605000311651
    Auxiliary studies Yes -previous and follow-up studies are listed separately
    Trial registration of auxiliary studies ACTRN12605000266662
    Funding sources

    Health Research Council, New Zealand

    The Auckland Medical Research Council

    The Evelyn Bond Trust, Auckland

    The National Health and Medical Research Council, Australia

    Study website N/A
    Are data available for sharing? Contact the principal investigator for information
    Study background To determine the long term effects of metformin or insulin, the offspring of women who have been randomised in the MiG study were followed through childhood to assess growth, adiposity and development
    Study design

    Observational

    Longitudinal

    Age of participants
    2 years old
    Related documents available (data dictionaries, protocols)? Rowan JA, Rush EC, Obolonkin V, Battin M, Wouldes T, Hague WM. Metformin in gestational diabetes: the offspring follow-up (MiG TOFU): body composition at 2 years of age. Diabetes care. 2011 Oct 1;34(10):2279-84
    Sample (N) International: 323 mother/offspring dyads
    Eligibility criteria Only mothers/offspring recruited in the Metformin in Gestational diabetes (MiG) trial from two recruitment sites (Auckland, New Zealand and Adelaide, Australia) were eligible for this study 
    Participant recruitment period November 2004 to February 2008
    Sociodemographic measures Family socioeconomic conditions, home environment, drug and alcohol intake, maternal and child health, diet (24-h recall, unnamed) and food frequency questionnaires (unnamed), child physical activity (24-h activity diary, unnamed)
    Child anthropomorphic measures Weight, height, leg length, head, chest, waist, hip and mid-upper arm circumferences, biceps/triceps/subscapular skinfolds
    Mental health measures N/A
    Maternal clinical assessments Weight, height, leg length, head, chest, waist, hip and mid-upper arm circumferences, biceps/triceps/subscapular skinfolds
    Child clinical assessments General physical examination by a paediatrician including blood pressure, neurodevelopmental assessment by a psychologist
    Other domains N/A
    Imaging (ultrasound, etc)

    Maternal and child dual energy X-ray absorptiometry (DEXA) measurement

    Child hand-to-foot single-frequency (50 kHz) bio impedance analysis

    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods N/A
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics Northern A Health and Disability Ethics Committee, Auckland Women's and Children's Hospital Network Human Research Ethics Committee, Adelaide
  • MiG:TOFU (7-9 years): Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin, 7-9 years
    Study name Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin
    Study abbreviation MiG:TOFU (7-9 years)
    Recruitment status Closed
    Current principal investigator(s)

    New Zealand: Dr Janet Rowan, National Women's Health, Auckland, New Zealand

    jrowan@internet.co.nz

    Australia: Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre N/A
    Primary institution National Women's Health, Auckland, New Zealand
    Collaborating institutions The University of Adelaide
    Participant recruitment site

    Auckland, New Zealand

    Adelaide, Australia

    Study Coordinator

    Dr Suzette Coat

    suzette.coat@adelaide.edu.au

    Contact details

    Dr Janet Rowan

    jrowan@internet.co.nz

    Trial registration number ACTRN12605000311651
    Auxiliary studies Yes -previous studies are listed separately
    Trial registration of auxiliary studies ACTRN12605000266662
    Funding sources

    Health Research Council, New Zealand

    The Auckland Medical Research Council

    The Evelyn Bond Trust, Auckland

    The National Health and Medical Research Council, Australia

    Study website N/A
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background The aim of the MiG TOFU 7–9 years of age follow-up study was to compare body composition and markers of insulin sensitivity in offspring of women with GDM randomized to metformin (plus supplemental insulin as required) or insulin
    Study design

    Observational

    Longitudinal

    Age of participants

    7 years old (Adelaide)

    9 Years (Auckland)

    Related documents available (data dictionaries, protocols)? Rowan JA, Rush EC, Plank LD, Lu J, Obolonkin V, Coat S, Hague WM. Metformin in gestational diabetes: the offspring follow-up (MiG TOFU): body composition and metabolic outcomes at 7–9 years of age. BMJ Open Diabetes Research and Care. 2018 Apr 1;6(1):e000456.
    Sample (N)

    Adelaide: 109 children

    Auckland: 99 children

    Eligibility criteria Only mothers/offspring recruited in the Metformin in Gestational diabetes (MiG) trial from two recruitment sites (Auckland, New Zealand and Adelaide, Australia) were eligible for this study 
    Participant recruitment period April 2011 to Dec 2013
    Sociodemographic measures Baseline demographic and lifestyle data (education, smoking, family medical history)
    Child anthropomorphic measures Weight, height, leg length, head, chest, waist, hip and mid-upper arm circumferences, biceps/triceps/subscapular skinfolds, Tanner stage of development (assessed by parents)
    Mental health measures N/A
    Maternal clinical assessments N/A
    Child clinical assessments
    Other domains Paternal height, weight and BMI
    Imaging (ultrasound, etc)

    Aged 7-9: Child dual energy X-ray absorptiometry (DEXA) measurement

    Aged 9: magnetic resonance imaging (MRI) and liver magnetic resonance spectroscopy (MRS), Auckland sample

    Aged 10: magnetic resonance imaging (MRI), Adelaide sample

    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods Child blood samples, fasting, for HbA1c and glucose
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics
  • OPTIMISE: Optimising gestational weight gain and Improving Maternal and Infant health outcomes through antenatal dietary, lifestyle and Exercise advice
    Study name Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial
    Study abbreviation OPTIMISE
    Recruitment status Recruiting
    Current principal investigator(s)

    Professor Jodie Dodd

    jodie.dodd@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre Australian Research Centre for the Health of Women & Babies
    Primary institution The University of Adelaide
    Collaborating institutions N/A
    Participant recruitment site The Womens and Childrens Hospital, North Adelaide
    Study Coordinator

    Andrea Deussen

    andrea.deussen@adelaide.edu.au

    Contact details jodie.dodd@adelaide.edu.au
    Trial registration number ACTRN12614000583640
    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources

    Lloyd Cox Strategic Research Excellence Award (University of Adelaide Discipline of Obstetrics and Gynaecology and Robinson Research Institute)

    National Health and Medical Research Council (NHMRC Practitioner Fellowship)

    Study website N/A
    Are data available for sharing? Applications in writing to Jodie Dodd
    Study aims To evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women of normal BMI
    Study design Randomised controlled trial
    Age of participants (across multiple follow ups)
    Related documents available (data dictionaries, protocols)? Dodd, J.M., Deussen, A.R. and Louise, J., 2018. Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial protocol. BMJ open, 8(2), p.e019583. https://bmjopen.bmj.com/content/8/2/e019583
    Sample (N) Target: 624 women
    Eligibility criteria Singleton, live gestation at 10-20 weeks, BMI between 18.5 to 24.9 kg/m2 at first antenatal visit are eligible for inclusion

    Women with a multiple pregnancy, or type two diabetes or gestational diabetes diagnosed before trial entry were excluded
    Participant recruitment period June 2014-?
    Sociodemographic measures Trial entry, 28 and 36 weeks of gestation and 6, 12 and 18–24 months after birth: maternal changes in diet and physical activity (Harvard Semi-quantitative Food Frequency Questionnaire and the Short Questionnaire to Assess Health-enhancing physical activity)
    Child anthropomorphic measures Birth: weight
    Mental health measures 6 months postpartum: Short Form-12 Health Survey Questionnaire, the Short Form Spielberger State Trait Inventory, the Edinburgh Postnatal Depression Scale, Modified previous childbirth questionnaire (also used in the LIMIT randomised trial)
    Maternal clinical assessments Trial entry, 28 and 36 weeks of gestation, and 6, 12 and 18–24 months after birth: maternal weight, skin-fold thickness, body circumferences and bioimpedance to assess adiposity
    Child clinical assessments N/A
    Other domains

    Costs of healthcare

    Imaging (ultrasound, etc) 28 and 36 weeks of gestation: ultrasound (fetal biometry, estimated weight, liquor volume, umbilical artery Doppler waveform and adiposity)
    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods N/A
    Biosamples: urine N/A
    Biosamples: faeces N/A
    Biosample: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? Hospital outpatient visits, inpatient admissions and published data sets including Pharmaceutical Benefits Scheme (PBS), Medical Benefits Schedule (MBS) and Australian Refined Diagnosis Related Groups
    Ethics Women's & Children's Hospital Network Human Research Ethics Committee
  • PAPO: Predicting Adverse Pregnancy Outcomes Study
    Study name Predicting Adverse Pregnancy Outcomes (PAPO) Study: An observational study to determine factors in both male and female partners to predict healthy pregnancies and adverse pregnancy outcomes
    Study abbreviation PAPO
    Recruitment status Closed
    Current principal investigator(s)

    Professor Claire Roberts

    claire.roberts@adelaide.edu.au

    Dr Denise Furness

    denise.furness@adelaide.edu.au

    Previous principal investigator(s)
    Research centre
    Primary institution The University of Adelaide
    Collaborating institutions

    Adelaide Women's and Children's Hospital

    Lyell McEwin Hospital Antenatal Clinic

    Participant recruitment site

    The Womens and Childrens Hospital, North Adelaide

    The Lyell McEwin Hospital, Elizabeth Vale

    Study Coordinator
    Contact details

    Dr Denise Furness

    denise.furness@adelaide.edu.au

    Trial registration number ACTRN12609000254291
    Auxiliary studies
    Trial registration of auxiliary studies
    Funding sources National Health and Medical Research Council (NHMRC)
    Study website
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background Investigating possible dietary, lifestyle or genetic causes or predictors of adverse pregnancy outcomes
    Study design Observational, longitudinal, prospective 
    Age of participants 18-55 years
    Related documents available (data dictionaries, protocols)?
    Sample (N)
    Eligibility criteria

    Before 12 weeks gestation, between the ages of 18-55 years, consenting

    Individuals with a serious medical illness or unable to consent were excluded

    Participant recruitment period
    Sociodemographic measures
    Child anthropomorphic measures
    Mental health measures
    Maternal clinical assessments
    Child clinical assessments
    Other domains
    Imaging (ultrasound, etc)
    Biosamples: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods

    Before pregnancy, 12 weeks gestation: mothers (concentrations of folate, vitamin 12, homocysteine and enzyme polymorphisms within folate metabolism)

    Bloods collected from fathers

    Biosamples: urine
    Biosamples: faeces
    Biosamples: saliva/baccal swab
    Other biological samples
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics Women's & Children's Hospital Network Human Research Ethics Committee (Ref: 1481/6/09)
  • SCOPE: The Screening for Pregnancy Endpoints project
    Study name

    Screening nulliparous women to identify the combinations of clinical risk factors and/or biomarkers required to predict preeclampsia, small for gestational age babies and spontaneous preterm birth

    Study abbreviation SCOPE
    Recruitment status Closed
    Current principal investigator(s)

    Professor Claire Roberts

    claire.roberts@adelaide.edu.au

    Professor Gustaaf Dekker

    gustaaf.dekker@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre N/A
    Primary institution University of Adelaide
    Collaborating institutions
    Participant recruitment site Lyell McEwin Hospital Antenatal Clinic
    Study Coordinator N/A
    Study contact N/A
    Trial registration number ACTRN12607000551493
    Auxiliary studies Planned but as yet unexecuted follow-up - children of women with asthma, allergy in offspring (pilot conducted, phone questionnaire, 100 women), plan to put in a grant
    Trial registration of auxiliary studies N/A
    Funding sources

    Foundation of Research Science and Technology

    Auckland District Health Board Charitable Trust

    Health Research Council

    Evelyn Bond Charitable Fund

    South Australia Premier Science and Research Fund

    Guys and St Thomas' Charity

    Health Research Board Ireland

    University of Manchester Proof of Concept Funding UK

    Biotechnology and Biological Sciences Research Council UK

    National Health Services NEAT Grant (UK)

    Tommy's the Baby Charity UK

    Cerebra

    National Health and Medical Research Council (NHMRC) (Project grant GNT519225) (Senior Researcher Fellowship GNT1020749) (Peter Doherty BioMedical Postdoctoral Fellowship GNT1090778)

    Study website http://www.scopestudy.net/
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background The primary aim of SCOPE is to produce clinically useful screening tests based on 1) clinical risk factors, 2) biomarkers and 3) a combination of clinical risk factors and biomarkers to detect first time mothers at high risk of preeclampsia, spontaneous preterm birth and/or small for gestational age babies.
    Study design Observational, retrospective
    Age of participants

    Related documents available (data dictionaries, protocols)?

    Data dictionary, user guides, lifestyle questionnaire

    Contact the principal investigator(s) for documents

    Sample (N)

    5,628 women internationally, total of 2,065 live births.

    1,169 live births in Adelaide

    Eligibility criteria

    Nulliparous women, singleton pregnancy, 14-16(6)wks gestation, able to give informed consent

    Women who were unsure of their last menstrual period (LMP), unwilling to have ultrasound scan, had>=3 miscarriages, >=3 terminations, major fetal anomaly/abnormal karyotype, essential hypertension treated pre-pregnancy, moderate-severe hypertension at booking >=160/100 mmHg, diabetes, renal disease, systemic lupus erythematosus, anti-phospholipid syndrome, sickle cell disease, HIV positive, major uterine anomaly, cervical suture, knife cone biopsy, ruptured membranes now, long term steroids, treatment low-dose aspirin, treatment calcium (>1g/24h), treatment eicosopentanoic acid (fish oil), treatment vitamin C >=1000mg & Vit E >=400iu, treatment heparin/low molecular weight heparin were excluded

    Participant recruitment period Sept 2005 - Sept 2008 (last birth march 2009)
    Sociodemographic measures 15 and 20 weeks gestation: age, ethnicity, level of education, employment and income; medical/surgical and obstetric history (for the mother and first degree relatives), a lifestyle questionnaire (employment, Need for recovery scale, exercise, sleep, Behaviour Responses to Pregnancy' (modified Behavioural Responses to Illness Questionnaire (BRIQ)), relationships and support), diet and smoking
    Child anthropomorphic measures Birth: weight, length, arm, abdominal circumference, fat free mass % and density,
    Mental health measures 15 and 20 weeks gestation: Lifestyle questionnaire (Perceived Stress Scale (PSS),  Short form State-Trait Anxiety Inventory (STAI), Edinburgh Postnatal Depression Scale (EPDS))
    Maternal clinical assessments

    15 and 20 weeks gestation: Blood pressure, BMI, height and weight, waist, hip, arm, head circumference, skinfolds, glucose

    Birth: maternal glucose, blood pressure

    Child clinical assessments N/A
    Other domains

    N/A

    Imaging (ultrasound, etc)

    18-20, 24 weeks gestation: transvaginal ultrasound scan

    20 weeks gestation: umbilical and arteriae Doppler scans

    Biosamples: cord blood Birth: cord blood
    Biosamples: vaginal/cervical swabs

    15 and 20 weeks gestation: high vaginal swabs

    Also collected at "time of disease" or complication

    Biosamples: bloods

    15 and 20 weeks gestation: multi-aliquoted, plain serum/EDTA plasma/heparin plasma/citrate plasma

    20 weeks gestation: Partner’s blood or buccal smear specimen collected

    Bloods also collected at "time of disease" or complication

    Biosamples: urine 15 and 20 weeks gestation
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab

    20 weeks gestation: Partner’s blood or buccal smear specimen collected

    Birth: all babies provided a buccal swab and oragene saliva

    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics Central Northern Adelaide Health Service Ethics of Human Research Committee (approved 02/09/2005, reference number: REC 1714/5/Application number 2005082)
  • STOP: Screening Tests to Predict poor Outcomes in Pregnancy
    Study name Screening Tests to identify poor Outcomes in Pregnancy (STOP) Study
    Study abbreviation STOP
    Recruitment status Closed
    Current principal investigator(s)

    Professor Claire Roberts

    claire.roberts@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre
    Primary institution The University of Adelaide
    Collaborating institutions
    Participant recruitment site

    The Womens and Childrens Hospital, North Adelaide

    The Lyell McEwin Hospital, Elizabeth Vale

    Study Coordinator N/A
    Study contact

    claire.roberts@adelaide.edu.au

    Trial registration number ACTRN12614000985684
    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources The University of Adelaide
    Study website N/A
    Are data available for sharing? Contact the principal investigator(s) for more information
    Study background A prospective cohort study where women with a singleton pregnancy less than 12 weeks’ gestation attending the first antenatal clinic, their partners and babies will be recruited. The women will be monitored throughout pregnancy and pregnancy complications will be diagnosed using current international guidelines with the aim of developing screening tests to identify adverse pregnancy outcomes as early as at the 12th week of gestation
    Study design

    Observational

    Longitudinal

    Prospective

    Age of participants
    Related documents available (data dictionaries, protocols)?
    Sample (N) 5628 women
    Eligibility criteria

    Women with a singleton pregnancy less than 12 weeks’ gestation attending the first antenatal clinic, and their partners, were included

    Women with a multiple pregnancy, major fetal anomalies, known essential hypertension pre-pregnancy, whether or not on anti hypertensive medication OR Women who are not known to have hypertension, but have severe hypertension (blood pressure greater than 160/110mmHg) at booking, type I or II diabetes, renal disease, systemic lupus erythematosus and anti-phospholipid
    syndrome, known major uterine anomaly, cervical cone biopsy, more than 3 miscarriages, more than 3 terminations, treatment with low dose aspirin, calcium greater than 1g/24h, heparin, low molecular weight heparin, antioxidants (vitamin C and E) in a trial setting were excluded

    Participant recruitment period March 2015 - Dec 2017
    Sociodemographic measures 12 weeks gestation: mothers and partners age, ethnicity, level of education, employment and income; medical/surgical and obstetric history (for the mother and first degree relatives), diet, exercise, drug/alcohol use, smoking
    Child anthropomorphic measures Birth: weight, placental weight
    Mental health measures 12 weeks gestation: lifestyle questionnaire (anxiety and stress)
    Maternal clinical assessments

    12 weeks gestation: mothers and partners height, weight, blood pressure

    28 weeks gestation: oral glucose tolerance test

    Child clinical assessments Birth: gestational age, length, weight, APGAR score, presence/absence of any congenital malformations
    Other domains
    Imaging (ultrasound, etc)

    12 weeks gestation: doppler scan to assess the uterine artery blood flow

    18-20 weeks gestation: morphology ultrasound scan, transvaginal ultrasound scan, doppler scan

    Biosamples: cord blood Birth: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods

    12 weeks gestation: mothers and partners peripheral blood

    Bloods also collected at "time of disease" or diagnosis with a complication

    One in seven women who have uncomplicated pregnancies will be selected as late gestation controls and will be requested to give a blood sample for comparison

    Biosamples: urine

    12 weeks gestation: maternal urine

    Urine also collected at "time of disease" or diagnosis with a complication

    One in seven women who have uncomplicated pregnancies will be selected as late gestation controls and will be requested to give a urine sample for comparison

    Biosamples: faeces
    Biosamples: saliva/baccal swab

    12 weeks gestation: partners saliva

    Birth: infant buccal swab or saliva sample

    Other biological samples Birth: placenta sample
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics Women’s and Children’s Health Network Human Research Ethics Committee (approved: 16/10/2014, HREC/14/WCHN/90)
  • TIPPS: Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women
    Study name Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.
    Study abbreviation TTIPS
    Recruitment status Completed
    Current principal investigator(s)

    Canada: Dr Marc Rodger, Ottawa Hospital Research Institute, Ottawa, Canada

    mrodger@ohri.ca

    Australia: Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre

    Ottawa Hospital Research Institute

    http://www.ohri.ca/home.asp

    Primary institution University of Ottawa
    Collaborating institutions

    Ottawa Hospital Research Institute, Ottawa, Canada

    Canadian Institutes of Health Research (CIHR)

    Women's and Children's Hospital, Adelaide, Australia

    Participant recruitment site

    36 tertiary care centres in five countries (Australia, Canada, United Kingdom, United States of America)

     

    Australia, Women's and Children's Hospital, Adelaide

    Australia, The Royal Women's Hospital, Parkville

    Australia, King Edward Memorial Hospital for Women, Perth

    Australia, Townsville Hospital, Townsville

    Australia, Royal Brisbane and Women's Hospital, Brisbane

    Australia, Royal North Shore Hospital, North Shore

    Australia, Nepean Hospital, Kingswood

    New Zealand, Auckland

    United Kingdom, York

    United Kingdom, Bristol

    United Kingdom, Hull

    United Kingdom, Surrey

    United Kingdom, Manchester

    United Kingdom, Birmingham

    United Kingdom, London

    United Kingdom, Leicester

    United Kingdom, Leeds

    United Kingdom, Newcastle

    United Kingdom, Sunderland

    Canada, Ontario

    Canada, Nova Scotia

    Canada, Quebec

    Canada, British Columbia

    Canada, Saskatchewan

    Canada, Alberta

    United States of America, Rhode Island

    United States of America, Connecticut

    United States of America, Ohio

    United States of America, Minnesota

    United States of America, North Carolina

    United States of America, Illinois

    United States of America, Utah

    United States of America, Missouri

    United States of America, Texas

    United States of America, New Jersey

    United States of America, Tennessee

    United States of America, Maryland

    United Kingdom, Sheffield

    United Kingdom, Coventry and Warwickshire

    Study Coordinator

    Dr Suzette Coat

    suzette.coat@adelaide.edu.au

    Study contact

    Scientific queries: Dr Marc Rodger, The Ottawa Hospital, Ottawa, Canada mrodger@ohri.ca

    Trial registration number

    ACTRN12608000446369

    ClinicalTrials.gov number: NCT00967382

    International Standard Randomised Controlled Trial Number Register: ISRCTN87441504

    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources

    Heart and Stroke Foundation of Canada

    Canadian Institutes of Health Research

    The Ottawa Health Research Institute

    The Children's, Youth and Women's Health Service

    Study website http://www.healthypregnancy.ca  (site no longer live)
    Are data available for sharing? Contact the principle investigators for more information
    Study background Thrombophilia increases risk of pregnancy-associated venous thromboembolism, pregnancy loss and placenta-mediated pregnancy complications. Antepartum dalteparin may reduce the incidence of thrombophilia complications in pregnant women.
    Study design

    Randomised control trial

    Intervention

    Age of participants
    18 years and older
    Related documents available (data dictionaries, protocols)? Rodger MA, Hague WM, Kahn SR, Karovitch A, Sermer M, Clement AM, Coat S, Chan WS, Said J, Rey E, Robinson S. Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial. The Lancet. 2014 Nov 8;384(9955):1673-83.
    Sample (N) Internationally: 292 pregnant women with confirmed thrombophilia and at high risk for pregnancy complications
    Eligibility criteria

    Women, 18 years and older, between 4 weeks-20 weeks gestation, were eligible for inclusion if they had been diagnosed with preeclampsia or had an increased risk of placenta-mediated pregnancy complications or venous thromboembolism, and were able to give informed consent

    Women who were below legal age limit (country specific), over 21 weeks gestation, without confirmed thrombophilia, contraindication to heparin therapy, geographical inaccessibility, a need for anticoagulants, had previously participated in TIPPS, or who were unable/unwilling to provide informed consent were excluded

    Participant recruitment period Feb 2000 - Sept 2012
    Sociodemographic measures Ethic origin, smoking status, pre-pregnancy BMI, obstetrical history, previous pregnancy complications, VTE risk factors/events, medications
    Child anthropomorphic measures N/A
    Mental health measures N/A
    Maternal clinical assessments

    Recruitment: weight and height, blood pressure, thrombophilia inclusion criteria

    Recruitment, 12, 20, 28, 32, 36 weeks gestation: outcome and adverse events, weight, blood pressure, compliance with intervention

    Birth: outcomes and adverse events in labour and delivery (according to patient records)

    8, 16, 24, 30, 34, 35, 37, 38, 39, and 40 weeks gestation follow-up visits (by phone or face-to-face):

    Child clinical assessments Birth: mean birthweight and gestational age at delivery
    Other domains N/A
    Imaging (ultrasound, etc) 6 weeks post-partum: bone mineral density measured by dual energy X-ray absorptiometry (DXA) scan
    Biosamples: cord blood N/A
    Biosamples: vaginal/cervical swabs N/A
    Biosamples: bloods Recruitment, 12, 20, 28, 32, 36 weeks gestation, 6 weeks post-partum: complete blood count, serum creatinine liver function
    Biosamples: urine Recruitment, 12, 20, 28, 32, 36 weeks gestation, 6 weeks post-partum: urine dipstick assessment for protein and blood
    Biosamples: faeces N/A
    Biosamples: saliva/baccal swab N/A
    Other biological samples N/A
    Linkage (BioGrid, VPCDU, NAPLAN etc)? N/A
    Ethics

    Women's and Children's Hospital Research Ethics Committee (26/05/2004)

    The Royal Women's Hospital Human Ethics Committees (02/02/2006)

    Northern Sydney Health Hurman Research Ethics Committee (08/08/2008)

    King Edward Memorial Hospital for Women Ethics Committee (10/03/2008)

    Ottawa Hospital Research Ethics Board (OHREB, 25/02/2000)

  • The TURRIFIC Study: Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy
    Study name Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study
    Study abbreviation TURRIFIC
    Recruitment status Not yet recruiting
    Current principal investigator(s)

    Professor William Hague

    bill.hague@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre N/A
    Primary institution University of Adelaide
    Collaborating institutions Women’s and Children’s Hospital
    Participant recruitment site

    Australia

    Women’s and Children’s Hospital - North Adelaide

    The Canberra Hospital - Garran

    King Edward Memorial Hospital - Subiaco

    Royal North Shore Hospital - St Leonards

    Royal Hospital for Women - Randwick

    Royal Brisbane & Women’s Hospital - Herston

    Mercy Hospital for Women - Heidelberg

    Monash Medical Centre - Clayton campus – Clayton

     

    International

    London, United Kingdom

    Amsterdam, Netherlands

    Gothenburg, Sweden

    Study Coordinator

    Dr Suzette Coat

    suzette.coat@adelaide.edu.au

    Study contact

    Professor William Hague

    bill.hague@adelaide.edu.au

    Trial registration number ACTRN12618000332224p
    Auxiliary studies N/A
    Trial registration of auxiliary studies N/A
    Funding sources National Health and Medical Research Council
    Study website N/A
    Are data available for sharing? Contact the principal investigator for more information
    Study background Severe early-onset intrahepatic cholestasis of pregnancy (ICP), a recognised rare disease of pregnancy, is associated with increased rates of stillbirth, preterm birth and neonatal morbidity. The optimal treatment and management of women who are diagnosed with this condition are not known. By comparing the standard treatment used for cholestatic itch outside pregnancy (rifampicin) with a standard treatment of ICP (ursodeoxycholic acid - UDCA) this investigation aims to determine the comparative safety and efficacy of the intervention and to determine if early delivery is beneficial in such women
    Study design

    Randomised control trial

    Intervention

    Age of participants
    18 years and older
    Related documents available (data dictionaries, protocols)? N/A
    Sample (N) Target: 108 women
    Eligibility criteria

    Women, aged 18 years and older, between 14-34 weeks gestation with serum bile acids >40 umol/L, no known lethal fetal anomaly, a singleton pregnancy, receiving obstetric care in a consultant-led unit, and provided informed consent

    For women who have been determined to delivery within the next 48 hours, with an allergy to any component of the UDCA or Rifampicin tablets, multi-fetal gestation, diagnosed hepatitis A/B/C, current pre-eclampsia, a  known primary hepatic disorder, a known genetic disorder of bile acid transport, gestational diabetes, currently taking medication causing deranged liver enzymes or who has previously participation in TURRIFIC are excluded from participating

    Participant recruitment period Anticipated Oct 2018-Aug 2021
    Sociodemographic measures
    Child anthropomorphic measures
    Mental health measures
    Maternal clinical assessments
    Child clinical assessments
    Other domains
    Imaging (ultrasound, etc)
    Biosamples: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods
    Biosamples: urine
    Biosamples: faeces
    Biosamples: saliva/baccal swab
    Other biological samples
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics Women's & Children's Hospital Network Human Research Ethics Committee
  • TWINS: The Twins Timing of Birth Randomised trial
    Study name The Twins Timing of Birth Randomised Trial
    Study abbreviation TWINS
    Recruitment status Closed
    Current principal investigator(s)

    Professor Jodie Dodd

    jodie.dodd@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre

    The Twins Timing of Birth Trial Group

    Australian Research Centre for Health of Women and Babies (ARCH)

    Primary institution
    Collaborating institutions
    Participant recruitment site

    Australia:

    Caboolture Hospital, Qld

    John Hunter Hospital, NSW

    Logan Hospital, Qld

    Lyell McEwen Hospital, SA

    Mackay Base Hospital, Qld

    Nepean Hospital, NSW

    Redcliffe Hospital, Qld

    The Mater Hospital, Qld

    The Royal Women’s Hospital, Melbourne

    The Townsville Hospital, Qld

    The Women’s and Children’s Hospital and The Queen Elizabeth Hospital, SA


    International:

    Auckland City Hospital, New Zealand

    Sant’Anna Hospital, Turin, Italy

    Study Coordinator
    Study contact jodie.dodd@adelaide.edu.au 
    Trial registration number ISRCTN15761056
    Auxiliary studies
    Trial registration of auxiliary studies
    Funding sources
    Study website
    Are data available for sharing? Applications in writing to Jodie Dodd
    Study background To evaluate the optimal time of birth for women with an uncomplicated twin pregnancy at 37 weeks’ gestation
    Study design Randomised controlled trial, intervention
    Age of participants (across multiple follow ups)

    Mothers: 23-34 years

    Infants: Birth, 4 months and 18 months

    Related documents available (data dictionaries, protocols)?
    Sample (N)

    Initial study: 235 women with an uncomplicated twin pregnancy at 36(+6) weeks of gestation

    Followup at 4 mths: 197 women and 394 babies

    Follow up at 18 mths: 166 women and 332 babies

    Eligibility criteria

    Women with a twin pregnancy at 36(+6) weeks of gestation were eligible for inclusion

    Women who experienced the intrauterine fetal death of one or both fetuses at the time of trial entry; had an active labour; fetal distress or non-reassuring fetal heart rate trace; or maternal or fetal compromise were excluded from participating

    Participant recruitment period Feb 2003 - Aug 2010
    Sociodemographic measures Trial entry: SES Assessed by participant's residential postcode, smoking behaviour, ethnicity, planned mode of birth
    Child anthropomorphic measures Birth: weight
    Mental health measures
    Maternal clinical assessments

    Trial entry: height, weight, BMI

    Birth: Death or serious maternal outcome

    Child clinical assessments Birth: Apgar score, Cord pH, neonatal encephalopathy, measures of immaturity (one or more of use of ventilation, NICU admission, severe respiratory distress syndrome, chronic lung disease, proven necrotising enterocolitis, proven systemic infection), serious adverse infant outcomes including death
    Other domains
    Imaging (ultrasound, etc)
    Biosamples: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods
    Biosamples: urine
    Biosamples: faeces
    Biosamples: saliva/baccal swab
    Other biological samples
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics

    Women's & Children's Hospital Network Human Research Ethics Committee (ref: EC00197)

    Ethics approval was obtained from each individual collaborating site

  • WASH*T: Effect of Transfusion of Washed Red Blood Cells on Neonatal Outcome: A Randomised Controlled Trial
    Study name For extremely low gestational age newborns will transfusion of washed red blood cells as compared to standard non-washed red blood cells reduce the incidence of neonatal mortality and improve survival free of significant morbidity
    Study abbreviation WASH*T
    Recruitment status Recruiting
    Current principal investigator(s)

    Associate Professor Michael Stark

    michael.stark@adelaide.edu.au

    Previous principal investigator(s) N/A
    Research centre
    Primary institution Robinson Research Institute, University of Adelaide
    Collaborating institutions Australian Red Cross Blood Service
    Participant recruitment site

    Womens and Childrens Hospital, North Adelaide

    Flinders Medical Centre, Bedford Park

    Mercy Hospital for Women, Heidelberg

    The Royal Women's Hospital, Parkville

    Study Coordinator
    Study contact
    Trial registration number ACTRN12613000237785
    Auxiliary studies
    Trial registration of auxiliary studies
    Funding sources

    Robinson Research Institute, University of Adelaide

    Australian Red Cross Blood Service

    Study website
    Are data available for sharing?
    Study background

    The trial aims to identify if transfusion with washed packed red blood cells (PRBCs) reduces harm from transfusion in high-risk newborns

    Study design Randomised controlled trial, intervention
    Age of participants
    Enrolment: 23-29 weeks, monitored until discharge from hospital
    Related documents available (data dictionaries, protocols)?
    Sample (N) Target: 448 neonates
    Eligibility criteria

    Preterm infants (23-28 weeks gestation) or very low birth weight infants (less than 1500 g), or both, who received one or more washed packed RBC transfusions

    Infants with major congenital or chromosomal abnormalities and infants who have received a packed red blood cell transfusion in the first 24 hours of life are excluded

    Participant recruitment period
    Sociodemographic measures
    Child anthropomorphic measures
    Mental health measures
    Maternal clinical assessments
    Child clinical assessments 36 weeks corrected gestational age: shift O2 test for chronic lung disease, serial plasma cytokines, markers of endothelial activation, clinical outcomes at discharge from hospital
    Other domains
    Imaging (ultrasound, etc) 36 weeks corrected gestational age: cranial ultrasound
    Biosamples: cord blood
    Biosamples: vaginal/cervical swabs
    Biosamples: bloods

    Infants: plasma, whole blood (collected from transfusion packs at time of transfusion)

    Serial blood sampling across admission, dependent on frequency of transfusion

    Biosamples: urine
    Biosamples: faeces
    Biosamples: saliva/baccal swab
    Other biological samples
    Linkage (BioGrid, VPCDU, NAPLAN etc)?
    Ethics Women's & Children's Hospital Network Human Research Ethics Committee (HREC/12/WCHN/55)
Longitudinal studies
Study name Socio-demographics Child anthropomorphic measures Mental health measures Maternal clinical assessments Child clinical assessments Other domains
ENDIA    
Generation_1
Lucina      
SAECDP    
Clinical trials
Study name Socio-demographics Child anthropometry measures Mental health measures Maternal clinical assessments Child clinical assessments Other domains
FACT
FRUIT
GRoW
LIMIT
MiG
MiG:TOFU2
MiG:TOFU7-9
OPTIMISE
PAPO
SCOPE
STOP
TIPPS
TURRIFIC
TWINS  
WASH*T          

Longitudinal studies
Study name

Imaging/ Ultrasound

Cord blood Vaginal/ cervical swabs Blood sample Urine sample Faeces sample Saliva sample/ baccal swab Other
ENDIA
Generation_1
Lucina          
SAECDP              
Clinical trials
Study name Imaging/ Ultrasound Cord blood Vaginal/ cervical swabs Blood sample Urine sample Faeces sample Saliva sample/ baccal swab Other
FACT
FRUIT
GRoW
LIMIT
MiG
MiG:TOFU2
MiG:TOFU7-9
OPTIMISE
PAPO
SCOPE
STOP
TIPPS
TURRIFIC
TWINS
WASH*T          

Longitudinal studies
Study name Tools/measures
ENDIA
Generation_1
Lucina
SAECDP  
Clinical trials
Study name Tools/measures
FACT
FRUIT
GROW
LIMIT
MiG
MiG:TOFU2
MiG:TOFU7-9
OPTIMISE
PAPO
  • Food frequency questionnaire (unnamed)
SCOPE
STOP
TIPPS
TURRIFIC
TWINS
  • Maternal emotional well-being (unnamed)
  • Maternal satisfaction with care (unnamed)
WASH*T

 

All researchers with research projects related to the field of reproductive and paediatric health are invited to join the CIS Facility Study Register.

For information about the Register and to join the registry, please contact the CIS Facility Coordinator, Dr Stephanie Champion. Stephanie will assist you submitting the relevant information to appear in the registry. The CIS Facility Register will only include the summary information, not individual-level data. A template has been created for collecting data for the Register.

The information we are seeking for the Registry is based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement guidelines for reporting observational studies.

Data we are requesting:

  • The cohort/trial name and abbreviation
  • Recruitment status
  • The names of current (and previous investigators), including the lead investigator and study co-ordinators
  • Research affiliations
  • The trial registration number (if applicable)
  • Dates and sites of recruitment
  • Study background
    • Study design
    • Planned or completed follow-up studies and sub-studies
  • Funding sources
  • Study website address (if applicable)
  • Data sharing avenues
  • Sample size
  • Participant summary details (e.g. age at recruitment, sex, ethnicity)
    • Sample size (and response proportion if applicable)
    • Eligibility/exclusion criteria
    • Socio-demographic measures (including the names of tools or measures)
    • Anthropometry measures and clinical assessments (including the names of tools or measures)
    • Mental health and psychosocial scales (including the names of tools or measures)
    • Biological samples and measures
    • Details relating to bio-archiving*
    • Linkage
    • Ethics approvals

      (*this section of the website is still under development)

Additional information you may wish to provide:

  • Data dictionaries and study protocols
  • Key publications arising from the studies

You may choose to provide as much or as little detail about your studies, as is appropriate for your research/cohort. There is no minimum amount of data we expect. If you have any questions or concerns about the Register, please contact Stephanie for further information.

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The Robinson Research Institute