Metformin and Esomeprazole For Preterm Pre-eclampsia

Preeclampsia Severe Clinical Trial

Official title:

Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05232994
• Other study ID #: DDD# 605095
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Christiana Care Health Services
• Contact: Marwan Ma'ayeh, MD
• Phone: 302-319-5680
• Email: maayehmarwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Preeclampsia Severe
• Premature Birth
• Preterm Birth Complication

Intervention

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

Locations

Country	Name	City	State
United States	Christiana Care Health Systems	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean plasma difference in sFlt-1 from randomization to day 7		from randomization to day 7
Secondary	Mean plasma difference in vascular endothelial growth factor (VEGF)		from randomization to day 7
Secondary	Mean plasma difference in placental growth factor (PlGF) levels		from randomization to day 7
Secondary	Mean plasma difference in soluble endoglin (sEng)		from randomization to day 7
Secondary	Maternal death		At time of delivery
Secondary	Mean highest blood pressure during expectant management mmHg		At time of delivery
Secondary	Number of anti-hypertensive medications at delivery		at time of delivery
Secondary	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
Secondary	Gestational age at delivery		at time of delivery
Secondary	Neonatal intensive care unit (nicu) admission		at time of delivery