The Effect of Metformin in Pregnant Women Who Received Antenatal Corticosteroids on Glycemic Control and the Rate of Neonatal Hypoglycemia - Multicenter Prospective Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 4
- 主要终点
- The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)
研究概览
简要总结
Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes.
Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates.
In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women receiving betamethasone from 24 to 36.5 gestational weeks
- •Before or within 24 hours following the first dose of betamethasone
- •≥18 years old
排除标准
- •Women with pre-gestational and gestational diabetes mellitus (GDM)
- •Known allergic sensitivity to metformin
- •Known chronic heart failure
- •Known chronic renal failure
- •Refuse to participate
- •Refuse to perform glucose challenge test/glucose tolerance test later on
研究组 & 干预措施
metformin group
干预措施: Metformin (Drug)
结局指标
主要结局
The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)
时间窗: Up to 7 days after delivery or discharge (which ever comes first)
Mean maternal daily glucose values
时间窗: Up to 4 days
According to daily glucose charts
次要结局
- Mean maternal daily post-prandial glucose values(Up to 4 days)
- Percent of abnormal values in the daily glucose chart(Up to 4 days)
- Rate of neonates who will be admitted to the neonatal intensive care unit(Up to a week after delivery)
- Apgar score at 1 and 5 minutes(At delivery)
- Rate of cesarean sections and operative deliveries(At delivery)
- Mean maternal daily pre-prandial glucose values(Up to 4 days)
- Mean and lowest neonatal blood glucose values in preterm neonates(Up to 7 days after delivery or discharge (which ever comes first))
- Cord blood pH levels (when taken)(At delivery)
- The rate of neonates with hyperbilirubinemia(Up to 7 days after delivery or discharge (which ever comes first))
- Neonatal mean birth weight(at delivery)
- Neonatal mean head circumference(Up to 7 days after delivery or discharge (which ever comes first))
- The rate of fetal malformations and developmental disorders(Up to 7 days after delivery or discharge (which ever comes first))
- The rate of maternal adverse effects(48 hours)