Use of Combination Metformin and Esomeprazole in Preterm Pre-eclampsia: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Mean plasma difference in sFlt-1
研究概览
简要总结
The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia.
详细描述
BACKGROUND:
The pathophysiology of preeclampsia
To achieve normal vascular function during pregnancy, the placental vascular endothelium secretes vasoactive substances and growth factors, most notably vascular endothelial growth factor (VEGF), sFlt-1, placental growth factor (PlGF) and soluble endoglin (sEng). These substrates interact with maternal natural killer cells to promote remodeling of the uterine spiral arteries in order to create a uteroplacental interface. Circulating vasoconstrictors, such as Thromboxane A2, and vasodilators play an important role in regulating the vascular endothelium in response to the developing uteroplacental interface.
In patients with preeclampsia, however, trophoblast cells demonstrate insufficient invasion of the spiral arteries, leading to poor remodeling, narrow vessel diameter and high vascular resistance. The endothelial dysfunction occurs in two phases. In the first phase, defective placental trophoblastic invasion of the uterine spiral arteries occurs at 14-18 weeks of gestation. This dysfunctional invasion leads to poor uteroplacental blood flow and the release of antiangiogenic factors and vasoconstrictive substances in the second phase.
In Defense of Metformin, Esomeprazole
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years or older
- •Women diagnosed with preeclampsia or preeclampsia with severe features or superimposed preeclampsia with 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
- •Reflux disease or other conditions currently on esomeprazole
- •Contraindications to metformin, esomeprazole
- •Baseline creatinine >124 μmol/L
- •Hypersensitivity to metformin or esomeprazole
- •Current use of 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
Metformin and Esomeprazole
Patients diagnosed with preterm preeclampsia receive expectant management with additional metformin/esomeprazole.
干预措施: Metformin (Drug)
Metformin and Esomeprazole
Patients diagnosed with preterm preeclampsia receive expectant management with additional metformin/esomeprazole.
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Mean plasma difference in sFlt-1
时间窗: Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months
sFlt-1 from serum samples
次要结局
- Mean plasma difference in vascular endothelial growth factor (VEGF)(Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months)
- Mean plasma difference in placental growth factor (PIGF)(Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months)
- Mean plasma difference in soluble endoglin (sEng)(Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months)
- sFlt-1:PIGF ratio(Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months)
- Prolongation of gestation(Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months)
研究者
Kendall Bielak, MD
Resident Physician
Christiana Care Health Services