NCT03717701

Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

Combining Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia: A Double-Blind Randomized, Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pre-Eclampsia

Interventions

Type	Name	Description
DRUG	metformin	Patients will take metformin single dose of 1000 mg orally once a day
DRUG	esomeprazole	Patients will take esomeprazole single dose of 40 mg orally once a day
DRUG	Placebo	Patients will take inert tablets similar in appearance, color, and consistency

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-11-30
• Completion: 2021-01-01
• First posted: 2018-10-24
• Last updated: 2019-01-10

Locations

1 site across 1 country: Egypt