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Metformin and Esomeprazole For Preterm Pre-eclampsia

NCT05232994 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-02-10

No results posted yet for this study

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.

Conditions

  • Preeclampsia Severe
  • Preeclampsia Second Trimester
  • Preterm Birth Complication

Interventions

DRUG

Esomeprazole 20mg

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

Sponsors & Collaborators

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Matthew Hoffman, MD, MPH · ChristianaCare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232994 on ClinicalTrials.gov