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

NCT04855513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2022-03-29

No results posted yet for this study

Summary

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).

Conditions

  • Preeclampsia
  • Preeclampsia Severe
  • High Risk Pregnancy
  • Eclampsia

Interventions

DRUG

Metformin

Metformin is a medication used for treatment of diabetes. In this study it will be used to explore is potential role in prevention of preeclampsia. The drug will start before 12 week of pregnancy and continue till delivery

Sponsors & Collaborators

  • Sidra Medicine

    collaborator OTHER

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mahmoud Mohamed, MSc · Hamad Medical Corporation

  • Justin Konje, MD, PhD · Hamad Medical Corporation

  • Mohamed Bashir, MD · Hamad Medical Corporation

  • Damien Chausabel, PhD · Sidra Medicine

  • Bara Al Jarrah, BSE · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-04-24
Completion
2023-12-30

Countries

  • Qatar

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855513 on ClinicalTrials.gov