NCT05232994

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 soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

January 31, 2022

Last Update Submit

February 9, 2023

Conditions

Preeclampsia SeverePreeclampsia Second TrimesterPreterm Birth Complication

Outcome Measures

Primary Outcomes (1)

  • mean plasma difference in sFlt-1 from randomization to day 7

    from randomization to day 7

Secondary Outcomes (9)

  • Mean plasma difference in vascular endothelial growth factor (VEGF)

    from randomization to day 7

  • Mean plasma difference in placental growth factor (PlGF) levels

    from randomization to day 7

  • Mean plasma difference in soluble endoglin (sEng)

    from randomization to day 7

  • Maternal death

    At time of delivery

  • Mean highest blood pressure during expectant management mmHg

    At time of delivery

  • +4 more secondary outcomes

Study Arms (2)

combination metformin and esomeprazole

EXPERIMENTAL

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

Drug: Esomeprazole 20mg

expectant management

NO INTERVENTION

Interventions

Esomeprazole 20mgDRUG

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

Also known as: Metformin
combination metformin and esomeprazole

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Systems

Newark, Delaware, 19713, United States

Location

MeSH Terms

Interventions

EsomeprazoleMetformin

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiguanidesGuanidinesAmidines

Study Officials

  • Matthew Hoffman, MD, MPH

    ChristianaCare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwan Ma'ayeh, MD

CONTACT

302-319-5680maayehmarwan@gmail.com

Kendall M Bielak, MD

CONTACT

302-320-4414kendall.bielak@christianaacare.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

March 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data are available for 5 years at a third party website

Locations

US(1)