Health Condition 1: O149- Unspecified pre-eclampsia
Conditions
Interventions
Intervention1: Tablet aspirin 150mg and tablet metformin 1gm: Tablet aspirin 150mg once daily orally in night and Tablet metformin 500mg twice daily orally till 36 weeks of gestation
Control Intervent
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
Eligibility
Inclusion criteria
Inclusion criteria: Singleton pregnancies,Live fetus at 11 to 13 weeks of gestation,High-risk for preeclampsia at 11 to 13 weeks by FMF algorithm that is greater than or equal to 1 in 100, Consenting for study participation
Exclusion criteria
Exclusion criteria: Age less than 18 years old,Multiple pregnancies,Treatment with aspirin and or metformin at the time of screening,Medical conditions complicating the pregnancy like Renal, liver or heart failure, Hyperemesis gravidarum,Pregnancies complicated by major fetal abnormality identified during the first trimester 6.Hypersensitivity to aspirin, metformin hydrochloride and other biguanides ,Concurrent participation in another drug trial or at any time within the previous 28 days,Women with learning difficulties, or serious mental illness ,Active peptic ulceration or gastrointestinal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevention of early onset preeclampsiaTimepoint: Before 37 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| comparison of adverse feto-maternal outcomes and incidence of late onset preeclampsia between the two groupsTimepoint: During gestation and post delivery and At and after 37 weeks | — |
Countries
India
Contacts
Public ContactDr Mitul Suhane
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR
Outcome results
None listed