Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention
试验速览
- 阶段
- 4 期
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Development of Gestational Diabetes at any point during the course of pregnancy
研究概览
简要总结
Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.
详细描述
Gestational diabetes mellitus (GDM) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. The incidence is increasing reflecting changing pre-gravid female demographics. Once one pregnancy is complicated by GDM, subsequent pregnancies are more likely to be affected by the same condition. This reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of GDM recurrence. Evidence regarding further predictors of recurrent GDM is conflicting and measures that might prevent recurrence need exploring.
Metformin is commonly used in the treatment of established GDM and has been shown to reduce the incidence of GDM in the context of polycystic ovarian syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy;
- •8-22 weeks gestation
- •Previous pregnancy complicated by gestational diabetes
排除标准
- •Established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose ≥ 7.0mmol/L and/ or HbA1c ≥ 48mmol/mol); Contraindications to metformin therapy (creatinine ≥ 130μmol/L/ alanine transaminase ≥ 2.0 x upper limit normal/ previous intolerance to metformin)
- •Planned continued antenatal care/ delivery at centre not included in trial
- •Planned fast for cultural/ religious reasons e.g. Ramadan
研究组 & 干预措施
Intervention arm Metformin
Metformin (500mg tablets) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.
干预措施: Metformin (Drug)
Control arm placebo
Matched placebo tablets (500mg) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.
干预措施: placebo (Drug)
结局指标
主要结局
Development of Gestational Diabetes at any point during the course of pregnancy
时间窗: From 12 weeks pregnancy until the onset of labour
次要结局
- Postpartum glucose levels(6 weeks postpartum)
- Cost effectiveness of the intervention(From 12 weeks gestation until 6 weeks postpartum)
- Maternal gestational weight gain(Difference between weight at 12 weeks gestation and 36 weeks gestation)
- Levels of maternal physical and psychological health as assessed by questionnaires(From 12 weeks gestation until 6 weeks postpartum)
- Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).(At Birth)
- Requirement for insulin therapy(From 12 weeks gestation until 36 weeks gestation)
- Fetal birthweight and birthweight centile(At Birth)