Preeclampsia Clinical Trial
— PREMETOfficial title:
Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial
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).
Status | Not yet recruiting |
Enrollment | 414 |
Est. completion date | December 30, 2023 |
Est. primary completion date | April 24, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Qatar | Women Wellness and Research Center | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation | Sidra Medical and Research Center |
Qatar,
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* Note: There are 63 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of PET | To compare the incidence of PET between the metformin group (intervention group) versus control group | Through study completion period (3 years) | |
Primary | Evaluating PIGF/sFlt-1 as a prognostic marker in PET in Qatar | Comparing PIGF/sFlt-1 ratio in both groups before and after developing PET | Through study completion period (3 years) | |
Secondary | PIGF/sFlt-1 as a prognostic marker in PET patients | Comparing PIGF/sFlt-1 ratio in PET patients who received metformin versus PET patient in the standard care group | Through study completion period (3 years) | |
Secondary | Maternal outcomes | Comparing gestational age at PET onset, gestation age at delivery and PET severity between study groups | Through study completion period (3 years) |
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