Last reviewed · How we verify

NCT04855513: PREMET

Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial

Status unknown NA Last updated 29 March 2022
What this trial tests

NA trial testing Metformin in Preeclampsia in 414 participants. Status unknown.

Timeline
24 March 2022
Primary endpoint
24 April 2023
30 December 2023

Quick facts

Lead sponsorHamad Medical Corporation
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment414
Start date24 March 2022
Primary completion24 April 2023
Estimated completion30 December 2023
Sites1 location across Qatar

Drugs / interventions tested

Conditions studied

Sponsor

Hamad Medical Corporation — full company profile →

Who can join

Adults 18 to 45, female only, with Preeclampsia or Preeclampsia Severe. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label, randomized control trial (RCT) in which high risk for pre-eclampsia pregnant subjects will be randomly assigned to either an intervention group (metformin 1 gm twice daily plus aspirin 100 mg per day and standard of care) versus control group (aspirin 100 mg per day and standard of care) that will be administered between 11 to 13 weeks of gestation until delivery . Only women at high risk of pre-eclampsia as defined by the ACOG practice bulletin will be included (see inclusion criteria). Patient assignment will not be blinded as control group will not be given a placebo; the data will be analyzed on an intention to treat basis. Enrolled subjects will be followed throughout pregnancy and up to 30 days post-delivery (as per hospital practice).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. New Ideas for the Prevention and Treatment of Preeclampsia and Their Molecular Inspirations.
    Sakowicz A, Bralewska M, Rybak-Krzyszkowska M, Grzesiak M, et al · · 2023 · cited 28× · PMID 37569476 · DOI 10.3390/ijms241512100

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

Other recruiting trials for Preeclampsia

Currently open trials in the same condition.

Other Hamad Medical Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04855513.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing