Combining Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia: A Double-Blind Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prolongation of gestation measured from the time of enrollment to the time of delivery.
研究概览
简要总结
Preeclampsia is globally responsible for tens of thousands of maternal and neonatal deaths each year. Currently, there are no medical therapies to halt disease progression and expectant management and delivery remain the mainstay of treatment. An important step in the pathogenesis of preeclampsia is a poor placental invasion and the subsequent release of the anti-angiogenic factors soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng)into the maternal circulation. Given metformin and esomeprazole successfully mitigate key pathogenic features of preeclampsia, the investigator will study whether combining low-doses of metformin and esomeprazole may be additive or synergistic (or neither) in reducing sFlt-1 and sEng secretion, and mitigating endothelial dysfunction, compared to placebo.
详细描述
This is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the International Society for the Study of Hypertension in Pregnancy (ISSHP). The population of interest involves pregnant women diagnosed with pre-eclampsia at a gestational age between 28 and 32 weeks at Aswan university hospital will be invited to participate. To be enrolled, the treating team needs to have determined after their initial assessment that delivery is unlikely to be required within 48 h. A starting point of 28 weeks has been chosen as this would be the earliest gestation that Aswan university hospital to be viable and are suitable to be offered expectant management The intervention involves randomization to oral esomeprazole tablets40 mg plus metformin tablets 1000 mg or identical placebo tablets from recruitment until delivery. Randomization is achieved using computational random allocation, and both participants and researchers will be blinded to the intervention given.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
both participants and researchers will be blinded to the intervention given
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia
- •The patient will be managed with an expectant management
- •Give written informed consent
排除标准
- •Multiple pregnancies.
- •Previous hypersensitivity reaction esomeprazole or metformin
- •Contraindications to the use of esomeprazole or metformin
- •The patient is unable or unwilling to give consent
- •An established fetal compromise that necessitates delivery
- •The presence of any of the following at presentation:
- •Eclampsia.
- •Severe hypertension.
- •A cerebrovascular event as an ischemic or hemorrhagic stroke.
- •Renal impairment.
- •Signs of left ventricular failure which include pulmonary edema.
- •Disseminated intravascular coagulation (DIC)
- •Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)
研究组 & 干预措施
Placebo
Patients will take inert tablets similar in appearance, color, and consistency
干预措施: Placebo (Drug)
metformin and esomeprazole
Patients will take esomeprazole single dose of 40 mg orally once a day plus single dose of metformin 1000mg orally single dose once a day
干预措施: esomeprazole (Drug)
metformin and esomeprazole
Patients will take esomeprazole single dose of 40 mg orally once a day plus single dose of metformin 1000mg orally single dose once a day
干预措施: metformin (Drug)
结局指标
主要结局
Prolongation of gestation measured from the time of enrollment to the time of delivery.
时间窗: 4 weeks
Prolongation of gestation measured from the time of enrollment to the time of delivery.
次要结局
- Severe morbidity(4 weeks)
- The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy(4 weeks)
- Side effects(4 weeks)
研究者
hany farouk
Principal Investigator
Aswan University Hospital