Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
BMJ Open. 2022 Mar 30;12(3):e056282. doi: 10.1136/bmjopen-2021-056282.
Gestational diabetes mellitus (GDM) is a common disorder of pregnancy with health risks for mother and child during pregnancy, delivery and further lifetime, possibly leading to type 2 diabetes mellitus (T2DM). Current treatment is focused on reducing hyperglycaemia, by dietary and lifestyle intervention and, if glycaemic targets are not reached, insulin. Metformin is an oral blood glucose lowering drug and considered safe during pregnancy. It improves insulin sensitivity and has shown advantages, specifically regarding pregnancy-related outcomes and patient satisfaction, compared with insulin therapy. However, the role of metformin in addition to usual care is inconclusive and long-term outcome of metformin exposure in utero are lacking. The primary aim of this study is to investigate the early addition of metformin on pregnancy and long-term outcomes in GDM.
The Pregnancy Outcomes: Effects of Metformin study is a multicentre, open-label, randomised, controlled trial. Participants include women with GDM, between 16 and 32 weeks of gestation, who are randomised to either usual care or metformin added to usual care, with insulin rescue in both groups. Metformin is given up to 1 year after delivery. The study consists of three phases (A-C): A-until 6 weeks after delivery; B-until 1 year after delivery; C-observational study until 20 years after delivery. During phase A, the primary outcome is a composite score consisting of: (1) pregnancy-related hypertension, (2) large for gestational age neonate, (3) preterm delivery, (4) instrumental delivery, (5) caesarean delivery, (6) birth trauma, (7) neonatal hypoglycaemia, (8) neonatal intensive care admission. During phase B and C the primary outcome is the incidence of T2DM and (weight) development in mother and child.
The study was approved by the Central Committee on Research Involving Human Subjects in the Netherlands. Results will be submitted for publication in peer-reviewed journals.
NCT02947503.
妊娠糖尿病（GDM）是一种常见的妊娠疾病，会给母婴在妊娠、分娩和以后的生活中带来健康风险，可能导致 2 型糖尿病（T2DM）。目前的治疗方法侧重于通过饮食和生活方式干预来降低血糖水平，如果血糖目标未达到，则使用胰岛素。二甲双胍是一种口服降血糖药物，在妊娠期间被认为是安全的。它可以改善胰岛素敏感性，与胰岛素治疗相比，具有优势，特别是在与妊娠相关的结局和患者满意度方面。然而，二甲双胍在常规治疗之外的作用尚不确定，且宫内暴露于二甲双胍的长期结局尚不清楚。本研究的主要目的是研究 GDM 中二甲双胍的早期添加对妊娠和长期结局的影响。
妊娠结局：二甲双胍研究是一项多中心、开放标签、随机、对照试验。参与者包括妊娠 16 至 32 周的 GDM 妇女，她们被随机分配到常规治疗组或常规治疗加二甲双胍组，两组均在胰岛素治疗失败时进行胰岛素抢救。二甲双胍在分娩后使用 1 年。该研究包括三个阶段（A-C）：A-分娩后 6 周；B-分娩后 1 年；C-观察性研究至分娩后 20 年。在 A 阶段，主要结局是由以下 8 项组成的综合评分：（1）妊娠相关高血压；（2）巨大儿；（3）早产；（4）器械分娩；（5）剖宫产；（6）分娩创伤；（7）新生儿低血糖；（8）新生儿重症监护病房入院。在 B 和 C 阶段，主要结局是 T2DM 的发生率以及母婴的（体重）发育情况。
该研究已获得荷兰人体研究中央委员会的批准。研究结果将提交给同行评议的期刊发表。
NCT02947503。
