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.
| 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 |
| Study name | Status | Recruitment period | Sample | Recruitment locations |
|---|---|---|---|---|
| Brain blood flow responses in preterm babies treated with indomethacin or ibuprofen for patent ductus arteriosus | Recruiting | 2018 - current | Target: 50 infants | Women’s and Children’s Hospital, SA |
| 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 |
| The SAINT Trial | Recruiting | 2019 - current | Target: 148 infants | Women’s and Children’s Hospital, SA Lyell McEwin Hospital, SA Monash Children's Hospital, VIC |
| 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 |
| 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 | ✓ | ✓ |
| Study name | Recruitment status | Sample | Pregnancy | Infancy | Childhood | Adulthood | Other family |
|---|---|---|---|---|---|---|---|
| Brain blood flow responses in preterm babies | Recruiting | 50 infants | ✓ | ✓ | |||
| 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 | ✓ | ✓ | |||
| The SAINT Trial | Recruiting | Target: 148 infants | ✓ | ✓ | |||
| 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
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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) 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 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 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) 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 Study contact 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) 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 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
2011
2012
2015
2018
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
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) 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
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Brain blood flow responses in preterm babies treated with indomethacin or ibuprofen for patent ductus arteriosus
Study name Brain blood flow responses in preterm babies treated with indomethacin or ibuprofen for patent ductus arteriosus Study abbreviation Brain blood flow responses in preterm babies Recruitment status Recruiting Current principal investigator(s) Previous principal investigator(s) Research centre Primary institution Collaborating institutions Participant recruitment site Study Coordinator Study contact Trial registration number Auxiliary studies Trial registration of auxiliary studies Funding sources Study website Are data available for sharing? Contact the principle investigator for information Study background Study design Age of participants Related documents available (data dictionaries, protocols)? Sample (N) Eligibility criteria 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 Biosamples: urine Biosamples: faeces Biosamples: saliva/baccal swab Other biological samples Linkage (BioGrid, VPCDU, NAPLAN etc)? Ethics -
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
Previous principal investigator(s) N/A Research centre 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 Study contact Dr Shi Wu Wen
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) 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 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) 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 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)
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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
Australia: Professor William Hague
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 Study contact 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
Australia: Professor William Hague
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 Contact details 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
Australia: Professor William Hague
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 Contact details 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) 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 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 excludedParticipant 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) claire.roberts@adelaide.edu.au
Dr Denise Furness
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
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) -
The SAINT Trial: Surfactant by supraglottic Airway versus direct laryngoscopy IN late preterm and Term newborns
Study name The SAINT Trial: Surfactant by supraglottic Airway versus direct laryngoscopy IN late preterm and Term newborns
Scientific name: Surfactant administration by either supraglottic airway device (SAD) or direct laryngoscopy in late preterm and term newborns on nasal continuous positive airway pressure (nCPAP): A randomised, multi-centre, non-inferiority trial
Study abbreviation SAINT Recruitment status Recruiting Current principal investigator(s) Previous principal investigator(s) Research centre Primary institution Collaborating institutions Adelaide Women's and Children's Hospital
Lyell McEwin Hospital Antenatal Clinic
Monash Children’s Hospital, Victoria
Participant recruitment site The Womens and Childrens Hospital, North Adelaide
The Lyell McEwin Hospital, Elizabeth Vale
Monash Children’s Hospital, Clayton
Study Coordinator Contact details Trial registration number ACTRN12619000995178p Auxiliary studies Trial registration of auxiliary studies Funding sources Women's and Children's Hospital Study website Are data available for sharing? Contact the principal investigator(s) for more information Study background Study design Age of participants Related documents available (data dictionaries, protocols)? Sample (N) Eligibility criteria 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 Biosamples: urine Biosamples: faeces Biosamples: saliva/baccal swab Other biological samples Linkage (BioGrid, VPCDU, NAPLAN etc)? Ethics Submitted, not yet approved: Women's & Children's Hospital Network Human Research Ethics Committee -
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) 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) 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 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 excludedParticipant 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
Australia: Professor William Hague
Previous principal investigator(s) N/A Research centre Ottawa Hospital Research Institute
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 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)
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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) 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 Study contact 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) 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
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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) 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)
| Study name | Socio-demographics | Child anthropomorphic measures | Mental health measures | Maternal clinical assessments | Child clinical assessments | Other domains |
|---|---|---|---|---|---|---|
| ENDIA | ✓ | ✓ | ✓ | |||
| Generation_1 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Lucina | ✓ | ✓ | ✓ | |||
| SAECDP | ✓ | ✓ | ✓ |
| 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 | ✓ |
| 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 |
| 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 | ✓ | ✓ |
| Study name | Tools/measures |
|---|---|
| Brain blood flow responses in preterm babies | |
| FACT | |
| FRUIT | |
| GROW |
|
| LIMIT |
|
| MiG | |
| MiG:TOFU2 | |
| MiG:TOFU7-9 | |
| OPTIMISE |
|
| PAPO |
|
| The SAINT Trial | |
| SCOPE |
|
| STOP |
|
| TIPPS | |
| TURRIFIC | |
| TWINS |
|
| WASH*T |
|