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RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

Phase 3
Not Enrolling
Preeclampsia, Eclampsia, HELLP Syndrome, Pregnancy

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Trial Information

RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

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

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,

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Incidence of preeclampsia

Principal Investigator

Joseph A. Spinnato, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati


United States: Federal Government

Study ID:

GN 05



Start Date:

July 2003

Completion Date:

December 2006

Related Keywords:

  • Preeclampsia
  • Eclampsia
  • HELLP Syndrome
  • Pregnancy
  • Vitamin C
  • Vitamin E
  • Preeclampsia
  • Antioxidants
  • Global Network
  • Preterm birth
  • Low birth weight infants
  • Brazil
  • Brasil
  • Maternal and child health
  • International
  • Women's health
  • Eclampsia
  • Pre-Eclampsia
  • HELLP Syndrome