Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
BMJ Open. 2020 May 17;10(5):e036198. doi: 10.1136/bmjopen-2019-036198.
Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.
Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.
The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.
ISRCTN20930880.
多达一半被诊断为妊娠期糖尿病的女性在分娩后 5 年内会发展为 2 型糖尿病。二甲双胍在预防高危非妊娠人群 2 型糖尿病方面有效，但在产后开始使用的效果尚不清楚。我们计划通过一项随机试验，评估在有妊娠期糖尿病史的产后女性中，使用二甲双胍与安慰剂相比，在减少产后血糖异常（包括 2 型糖尿病）风险方面的可行性，以评估二甲双胍在预防妊娠期糖尿病后的糖尿病（OMAhA）中的作用。
通过优化二甲双胍治疗产后健康结局（OMAhA），这是一项多中心安慰剂对照双盲随机可行性试验，我们将随机分配 160 名接受药物治疗的有妊娠期糖尿病史的产后女性，分为二甲双胍（干预）或安慰剂（对照）组，持续服用至产后 1 年。主要结局是招募率、随机化、依从性和失访率。次要结局是两组的产妇血糖异常、成本和生活质量结局，以及研究和干预措施的可接受性，这将通过嵌套定性研究进行评估。可行性结局将使用描述性统计、点估计和 95%置信区间进行总结。
OMAhA 研究获得了伦敦-布伦特研究伦理委员会（18/LO/0505）的伦理批准。试验结果将发表在同行评议的期刊上，在会议上传播，通过我们的患者和公众参与咨询小组（凯蒂团队）以及通过社交媒体平台传播。
ISRCTN20930880。
