RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Cincinnati
Universidade Federal de Pernambuco
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
University of Campinas, Brazil
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00097110
First received: November 17, 2004
Last updated: November 22, 2013
Last verified: November 2013

November 17, 2004
November 22, 2013
July 2003
Not Provided
Incidence of preeclampsia
Same as current
Complete list of historical versions of study NCT00097110 on ClinicalTrials.gov Archive Site
  • Severity of preeclampsia
  • Incidence of gestational hypertension or preeclampsia
  • Frequency of abruptio placentae
  • Incidence of preterm birth
  • Incidence of small for gestational age
  • Incidence of low birth weight infants
  • Biomarker level correlation with preeclampsia
Same as current
Not Provided
Not Provided
 
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Preeclampsia
  • Eclampsia
  • HELLP Syndrome
  • Pregnancy
Drug: Vitamin C and E
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
734
December 2006
Not Provided

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.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00097110
GN 05, U01 HD040565
Yes
NICHD Global Network for Women's and Children's Health
NICHD Global Network for Women's and Children's Health
  • Global Network for Women's and Children's Health Research
  • Bill and Melinda Gates Foundation
  • John E. Fogarty International Center (FIC)
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Cancer Institute (NCI)
  • RTI International
  • University of Cincinnati
  • Universidade Federal de Pernambuco
  • Feculdade de Medicina da Universidade de Sao Paulo - Brasil
  • Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
  • University of Campinas, Brazil
  • Hospital de Clinicas de Porto Alegre
Principal Investigator: Joseph A. Spinnato, M.D. University of Cincinnati
NICHD Global Network for Women's and Children's Health
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP