Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aswan University Hospital
• Treatments: Esomeprazole; Metformin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)