IDEAL: Investigation of Dietary Advice and lifestyle for women with borderline Gestational Diabetes Mellitus.
This trial has completed recruitment and 4 month followup is currently being undertaken.
With the publication of the ACHOIS trial it is now clear that treatment of pregnant women with mild gestational diabetes, formerly defined as impaired glucose tolerance, is beneficial for women and their infants (Crowther et al 2005). There remains, however, a lack of high quality evidence as to whether the benefits of similar treatment for women with borderline gestational glucose intolerance outweigh any harms. The recent report of a randomised trial in women who had a positive oral glucose challenge test and a subsequent normal oral glucose tolerance test and received treatment with dietary advice and blood glucose monitoring showed promising results, in that the risk of macrosomia was reduced (Bonomo et al 2005). However there are insufficient data from this or other studies about clinically important health outcomes such as other infant morbidity, maternal physical and psychological morbidity and costs to enable informed decision-making.
The aims of this large, multicentre randomised clinical trial are to assess whether treatment of dietary and lifestyle advice, given to pregnant women who have borderline glucose intolerance on screening for gestational diabetes, (defined as a positive oral glucose challenge screening test followed by a normal oral glucose tolerance test), reduces neonatal complications without increasing maternal risks, and whether resources should be allocated for such treatment.
|Funding:||Four month followup: NHMRC Project Grant, 2011-2014; Channel 7 Research Foundation, 2007-2009|
|Chief Investigators:||Professor Caroline Crowther, Ms Philippa Middleton, A/Professor Bill Hague, A/Professor Peter Baghurst, Dr Andrew McPhee, Professor Jodie Dodd, E/Professor Jeffrey Robinson|
|Clinical Trial Coordinator:||Ms Pat Ashwood|
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61 8 8161 7652
SA - Women's & Children's Hospital
- Crowther CA, Hague WM, Middleton PF, Baghurst PA, McPhee AJ, Tran TS, Yelland LN, Ashwood P, Han S, Dodd JM et al: The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol. BMC Pregnancy and Childbirth 2012, 12. (Protocol).
- Han S, Crowther CA, Middleton P. Different types of dietary advice for women with gestational diabetes mellitus (Protocol). Cochrane Database Syst Rev. 2011(8).
- Han S, Crowther CA, Middleton P. Exercise for pregnant women for preventing gestational diabetes mellitus (Protocol). Cochrane Database Syst Rev. 2011(3).
- Han S, Crowther CA, Middleton P. Interventions for pregnant women with hyperglycaemia not meeting gestational diabetes and type 2 diabetes diagnostic criteria (Protocol). Cochrane Database Syst Rev. 2011(3).
- Dodd JM, Crowther CA, Antoniou G, Baghurst P, Robinson JR. Screening for gestational diabetes: the effect of varying blood glucose definitions in the prediction of adverse maternal and infant health outcomes. Aust N Z J Obstet Gynaecol. 2007 Aug;47(4):307-12.
- Moss JR, Crowther CA, Hiller JE, Willson KJ, Robinson JS, ACHOIS Trial group TA. Costs and consequences of treatment for mild gestational diabetes mellitus - evaluation from the ACHOIS randomised trial. BMC Pregnancy Childbirth. 2007 Oct 28;7(1):27.
- Rumbold AR, Crowther CA, Haslam RR, Dekker GA, Robinson JS for the ACTS Study Group. Vitamins C and E and the risks of preeclampsia and perinatal complications. N Engl J Med 2006;254(17):1796-1806.
- Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med 2005;352, 2477-2486.