Metformin and Esomeprazole For Preterm Pre-eclampsia

Christiana Care Health Services

Status and phase: Not yet enrolling; Phase 1

Conditions: Preeclampsia Severe; Preterm Birth Complication; Preeclampsia Second Trimester

Treatments: Drug: Esomeprazole 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05232994

DDD# 605095

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

combination metformin and esomeprazole

Experimental group

Description:

Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.

Treatment:

Drug: Esomeprazole 20mg

expectant management

No Intervention group