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
  Purpose

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.


Condition Intervention Phase
Preeclampsia
Eclampsia
HELLP Syndrome
Pregnancy
Drug: Vitamin C and E
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Incidence of preeclampsia

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 734
Study Start Date: July 2003
Study Completion Date: December 2006
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 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097110

Locations
Brazil
Federal University of Pernambuco
Recife, Pernambuco, Brazil
Sponsors and Collaborators
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
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
Investigators
Principal Investigator: Joseph A. Spinnato, M.D. University of Cincinnati
  More Information

Additional Information:
No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00097110     History of Changes
Other Study ID Numbers: GN 05, U01 HD040565
Study First Received: November 17, 2004
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Vitamin C
Vitamin E
Preeclampsia
Antioxidants
Global Network
Preterm birth
Low birth weight infants
Brazil
Brasil
Maternal and child health
International
Women's health

Additional relevant MeSH terms:
HELLP Syndrome
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vitamins
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014