ISRCTN13866189进行中（未招募）3 期
Metformin impact on maternal and infant cardiometabolic health
niversity of Manchester0 个研究点目标入组 225 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Singleton pregnancy between 6+0 and 30+0 weeks’ gestation inclusive
- •2. Aged 18 years or over and willing and able to give informed consent
- •3. Diagnosis of diabetes in pregnancy
- •3.1. Type 2 diabetes diagnosed before pregnancy and requiring pharmacological treatment
- •3.2. Type 2/GDM diagnosed <24 weeks’ gestation: abnormal glucose tolerance test, abnormal HBGM and/or HbA1C =42mmol/L
- •3.3. GDM (diagnosed 24-30 weeks): HbA1C =39mmol/L and/or abnormal glucose tolerance test
- •4. Abnormal HBGMb (=30 weeks)
- •5. Presence of at least one risk factor for placental disease
- •5.1. BP =130 and/or =80mmHg (clinic blood pressure)
- •5.2. Pulse wave velocity = 9m/s
- •5.3. Age =35 years
- •5.4. Nulliparous
- •5.5. Pre-eclampsia and/or small for gestational age (<10th centile) in a prior pregnancy
- •5.6. Mean uterine artery PI =95th centile
- •5.7. Placental growth factor <10th centile
- •6. EFW =50th centile (if =22 weeks)
排除标准
- •1. Medical contraindication to metformin
- •2. Known diagnosis of Type 1 diabetes
- •3. Multifetal pregnancy
- •4. Prior pregnancy complicated by shoulder dystocia
研究者
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