Australian Research Centre for Health of Women and Babies (ARCH), The Robinson Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia.
BMC Pregnancy Childbirth. 2012 Oct 9;12:106. doi: 10.1186/1471-2393-12-106.
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.
Multicentre, randomised controlled trial.
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.
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.
A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants.
Australian New Zealand Clinical Trials Registry - ACTRN12607000174482.
澳大利亚妊娠妇女碳水化合物不耐受研究（ACHOIS）表明，治疗轻度妊娠糖尿病孕妇对母婴均有益。对于边缘性妊娠糖尿病孕妇，类似治疗是否有益仍不确定。本试验旨在评估对筛查出边缘性妊娠糖尿病的孕妇进行饮食和生活方式建议及治疗是否可减少新生儿并发症和产妇发病率。
多中心随机对照试验。
孕周 240-346 周、单胎妊娠、口服葡萄糖耐量试验阳性（静脉血浆葡萄糖≥7.8mmol/L）、口服 75g 葡萄糖耐量试验正常（空腹静脉血浆葡萄糖<5.5mmol/L，2 小时血糖<7.8mmol/L）、签署书面知情同意书的孕妇。
口服葡萄糖耐量试验异常（空腹静脉血浆葡萄糖≥5.5mmol/L 或 2 小时血糖≥7.8mmol/L）的孕妇不符合纳入标准，将给予基于 ACHOIS 试验结果的妊娠期糖尿病治疗。符合条件的孕妇将被随机分为“常规护理组”或“干预组”。
“常规护理组”的孕妇将接受常规产科护理，反映澳大利亚医院当前的临床实践。“干预组”的孕妇将接受产科护理，包括饮食和生活方式建议、血糖监测以及适当的高血糖进一步医学治疗。
巨大儿的发生率。
682 例孕妇的样本量足以显示饮食和生活方式建议及治疗可使巨大儿的风险从 14%降低至 7%，降低幅度达 50%（双侧α 0.05，80%效能，4%失访）。
明确的试验结果将为边缘性葡萄糖不耐受妊娠妇女及其婴儿的护理提供可靠的相关证据。
澳大利亚新西兰临床试验注册中心-ACTRN12607000174482。
