RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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 antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Bill and Melinda Gates Foundation; Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil; Feculdade de Medicina da Universidade de Sao Paulo - Brasil; Fogarty International Center of the National Institute of Health; Global Network for Women's and Children's Health Research; Hospital de Clinicas de Porto Alegre; John E. Fogarty International Center (FIC); National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH); National Institute of Dental and Craniofacial Research (NIDCR); RTI International; Universidade Federal de Pernambuco; University of Campinas, Brazil; University of Cincinnati
• Treatments: Antioxidants; Ascorbic Acid; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.