Trials / Unknown
UnknownNCT05232994
Metformin and Esomeprazole For Preterm Pre-eclampsia
Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- Christiana Care Health Services · Academic / Other
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole 20mg | Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery. |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2022-02-10
- Last updated
- 2023-02-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05232994. Inclusion in this directory is not an endorsement.