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

Jeffrey S Robinson³  Jodie M Dodd³  Shan Han³  Pat Ashwood³  Lisa N Yelland³  Thach S Tran³  Andrew J McPhee²  Peter A Baghurst¹  Philippa F Middleton³  William M Hague³  Caroline A Crowther⁴ 

[1] Discipline of Public Health, The University of Adelaide, Adelaide, Australia;Department of Neonatology, The Women’s and Children’s Hospital, Adelaide, South Australia, Australia;Australian Research Centre for Health of Women and Babies (ARCH), The Robinson Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia;The University of Adelaide, Women’s & Children’s Hospital, 72 King William Road, North Adelaide, 5006, South Australia, Australia

关键词: Large for gestational age;    Lifestyle;    Diet;    Randomised controlled trial;    Gestational diabetes mellitus;    Borderline gestational diabetes;   

Others  :  1152204
DOI  :  10.1186/1471-2393-12-106

 received in 2012-07-24, accepted in 2012-10-01,  发布年份 2012

【 摘 要 】

Background

The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes.

This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities.

Methods/design

Design: Multicentre, randomised controlled trial.

Inclusion criteria: Women between 24⁰ and 34⁶ weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L) and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L) with written, informed consent.

Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L) will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the ‘Routine Care Group’ or the ‘Intervention Group’.

Study groups: Women in the ‘Routine Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive obstetric care, which will include dietary and lifestyle advice, monitoring of blood glucose and further medical treatment for hyperglycaemia as appropriate.

Primary study outcome: Incidence of large for gestational age infants.

Sample size: A sample size of 682 women will be sufficient to show a 50% reduction in the risk of large for gestational age infants (alpha 0.05 two-tailed, 80% power, 4% loss to follow up) from 14% to 7% with dietary and lifestyle advice and treatment.

Discussion

A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants.

Trial registration

Australian New Zealand Clinical Trials Registry - ACTRN12607000174482

【 授权许可】

   
2012 Crowther et al.; licensee BioMed Central Ltd.

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