Status:
COMPLETED
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborating Sponsors:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
Conditions:
Preeclampsia
Eclampsia
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of anti...
Detailed Description
The maternal, perinatal and neonatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. In Sao Paulo, 22 percent of maternal deaths ar...
Eligibility Criteria
Inclusion
- Gestational age between 12 weeks and 19 weeks, 6 days, inclusive
- Chronic hypertension
- History of preeclampsia/eclampsia
- Attendance at a participating hospital (Recife, Botucatu, Campinas and Porto Alegre, Brazil)
Exclusion
- Planned delivery elsewhere.
- Multifetal gestation.
- Allergy to vitamin C or vitamin E.
- Requirement for aspirin or anticoagulant medication.
- Proteinuria ≥ 2+ on dipstick urine test; or proteinuria = 1+ on dipstick and ≥ 300 mg/24 hours.
- Pre-pregnancy diabetes mellitus.
- Known fetal anomaly incompatible with life.
- Prior participation in the study.
- Unwillingness to take the study medication.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
734 Patients enrolled
Trial Details
Trial ID
NCT00097110
Start Date
July 1 2003
End Date
December 1 2006
Last Update
November 25 2013
Active Locations (1)
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1
Federal University of Pernambuco
Recife, Pernambuco, Brazil