RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

NICHD Global Network for Women's and Children's Health

Status and phase

Completed

Phase 3

Conditions

Preeclampsia

HELLP Syndrome

Eclampsia

Pregnancy

Treatments

Drug: Vitamin C and E

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT00097110

U01HD040565 (U.S. NIH Grant/Contract)

GN 05

Details and patient eligibility

About

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.

Full 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 are attributable to hypertensive complications of pregnancy, which ranks as the number one cause of maternal death. Recent advances in the understanding of the pathophysiology of preeclampsia suggest the possibility of antioxidant therapy for the prevention of preeclampsia. The primary hypothesis is that the joint administration of the 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. Secondary outcomes include severity of preeclampsia; incidence of gestational hypertension; incidence of premature rupture of the membranes; incidence of preterm birth; incidence of low birth weight infants; biomarker level correlation with preeclampsia.

Study sites are high-risk obstetrical clinics in the Brazilian cities of Recife, Botucatu, Campinas, and Porto Alegre. The sample size was based on an estimated risk of preeclampsia/eclampsia of 21-25% in the control group. The study hypothesizes a 40% absolute reduction of risk of preeclampsia; early treatment withdrawal of 3%; withdrawal of consent or loss to follow-up of 10%; calculated at a 0.05 significance level with 80% power. Seven hundred thirty-four obstetric patients with chronic hypertension or preeclampsia in the prior pregnancy presenting for care between 12 weeks and 19 weeks', 6 days gestation will be randomized to a double-blinded placebo controlled trial to receive a daily dose of either vitamin E (400 International Units) and vitamin C (1000 mg) or placebo from the time of enrollment to delivery. The use of MEMS caps enables researchers to accurately track compliance.

Sex

Female

Volunteers

Accepts Healthy Volunteers

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.