Status:
UNKNOWN
Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial
Lead Sponsor:
Hamad Medical Corporation
Collaborating Sponsors:
Sidra Medicine
Conditions:
Preeclampsia
Preeclampsia Severe
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 ...
Detailed Description
Preeclampsia (PET) is one of the leading causes of maternal morbidity and mortality . Its pathophysiology is poorly understood. Consequently, there are no efficient preventive and treatment modality. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT04855513
Start Date
March 24 2022
End Date
December 30 2023
Last Update
March 29 2022
Active Locations (1)
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1
Women Wellness and Research Center
Doha, Qatar, 3050