Metformin and Esomeprazole For Preterm Pre-eclampsia

Phase 1

Not yet recruiting

• Conditions: Preterm Birth Complication; Preeclampsia Severe; Preeclampsia Second Trimester
• Interventions: Drug: Esomeprazole 20mg

• Registration Number: NCT05232994
• Lead Sponsor: Christiana Care Health Services

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Study Start: 2023-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
mean plasma difference in sFlt-1 from randomization to day 7	from randomization to day 7

Secondary Outcome Measures

Name	Time	Method
Neonatal intensive care unit (nicu) admission	at time of delivery
Mean plasma difference in vascular endothelial growth factor (VEGF)	from randomization to day 7
Number of anti-hypertensive medications at delivery	at time of delivery
Mean plasma difference in soluble endoglin (sEng)	from randomization to day 7
Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs	at time of delivery
Gestational age at delivery	at time of delivery
Mean highest blood pressure during expectant management mmHg	At time of delivery
Mean plasma difference in placental growth factor (PlGF) levels	from randomization to day 7
Maternal death	At time of delivery

Trial Locations

Locations (1)

Christiana Care Health Systems; 🇺🇸 Newark, Delaware, United States