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

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Collaborator: Sidra Medical and Research Center
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Confirmed pregnancy

• Gestational age < 12+0 weeks

• Live fetus at time of booking ultrasound scan (between 11+0 and 13+6 weeks of gestation)

• To be considered as high risk of preeclampsia

Exclusion Criteria:

• Age under 18 years

• Hyperemesis gravidarum

• Unable to sign the consent form

• Type 1 or 2 diabetes mellitus

• Early gestational diabetes

• Auto-immune disease

• Fetal abnormality identified at time of scanning (between 11+0 and 13+6 weeks of gestation)

• Bleeding disorder

• Peptic ulcer

• Hypersensitivity to aspirin or metformin

• Long use of NSAIDS before initiation of intervention

• Contraindication to metformin or aspirin and participation in another concurrent trial.