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Metformin and Esomeprazole For Preterm Pre-eclampsia

Sponsor
Christiana Care Health Services (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05232994
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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 sFlt-1 and soluble endoglin, and reduce endothelial dysfunction.

Condition or Disease Intervention/Treatment Phase
  • Drug: Esomeprazole 20mg
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: combination metformin and esomeprazole

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

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

    		•
    No Intervention: expectant management

    Outcome Measures

    Primary Outcome Measures

    1. mean plasma difference in sFlt-1 from randomization to day 7 [from randomization to day 7]

    Secondary Outcome Measures

    1. Mean plasma difference in vascular endothelial growth factor (VEGF) [from randomization to day 7]

    2. Mean plasma difference in placental growth factor (PlGF) levels [from randomization to day 7]

    3. Mean plasma difference in soluble endoglin (sEng) [from randomization to day 7]

    4. Maternal death [At time of delivery]

    5. Mean highest blood pressure during expectant management mmHg [At time of delivery]

    6. Number of anti-hypertensive medications at delivery [at time of delivery]

    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]

    8. Gestational age at delivery [at time of delivery]

    9. Neonatal intensive care unit (nicu) admission [at time of delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Christiana Care Health Systems Newark Delaware United States 19713

    Sponsors and Collaborators

    • Christiana Care Health Services

    Investigators

    • Principal Investigator: Matthew Hoffman, MD, MPH, ChristianaCare

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christiana Care Health Services
    ClinicalTrials.gov Identifier:
    NCT05232994
    Other Study ID Numbers:
    • DDD# 605095
    First Posted:
    Feb 10, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Premature Birth
    Pre-Eclampsia
    Eclampsia
    Metformin
    Esomeprazole

    Study Results

    No Results Posted as of Aug 25, 2022