Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial
Status:
Not yet recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
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).