Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- mean plasma difference in sFlt-1 from randomization to day 7
研究概览
简要总结
A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies
- •Women 18 years or older
- •Women diagnosed with preeclampsia
- •Women with pre-eclampsia superimposed on chronic hypertension
- •Candidates for expectant management and had no clinical indication for immediate delivery
排除标准
- •Delivery within 48hr is highly likely
- •Maternal or fetal compromise that necessitated immediate delivery
- •Diabetes or gestational diabetes currently on metformin therapy
- •Contraindications to metformin, esomeprazole
- •Baseline creatinine >124 μmol/L
- •Hypersensitivity to metformin or esomeprazole
- •Metabolic acidosis
- •Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations
研究组 & 干预措施
combination metformin and esomeprazole
Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.
干预措施: Esomeprazole 20mg (Drug)
结局指标
主要结局
mean plasma difference in sFlt-1 from randomization to day 7
时间窗: from randomization to day 7
次要结局
- Gestational age at delivery(at time of delivery)
- Mean plasma difference in vascular endothelial growth factor (VEGF)(from randomization to day 7)
- Number of anti-hypertensive medications at delivery(at time of delivery)
- Neonatal intensive care unit (nicu) admission(at time of delivery)
- Mean plasma difference in soluble endoglin (sEng)(from randomization to day 7)
- Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs(at time of delivery)
- Mean plasma difference in placental growth factor (PlGF) levels(from randomization to day 7)
- Maternal death(At time of delivery)
- Mean highest blood pressure during expectant management mmHg(At time of delivery)