Status:
UNKNOWN
Metformin and Esomeprazole For Preterm Pre-eclampsia
Lead Sponsor:
Christiana Care Health Services
Conditions:
Preeclampsia Severe
Preeclampsia Second Trimester
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05232994
Start Date
March 1 2023
End Date
December 31 2025
Last Update
February 10 2023
Active Locations (1)
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1
Christiana Care Health Systems
Newark, Delaware, United States, 19713