RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

Pregnancy Clinical Trial

Official title:

RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097110
• Other study ID #: GN 05
• Secondary ID: U01HD040565
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2004
• Last updated: November 22, 2013
• Start date: July 2003
• Est. completion date: December 2006

Study information

• Verified date: November 2013
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Eclampsia
• HELLP Syndrome
• Pre-Eclampsia
• Preeclampsia
• Pregnancy

Intervention

Drug:
• Vitamin C and E

Locations

Country	Name	City	State
Brazil	Federal University of Pernambuco	Recife	Pernambuco

Sponsors (14)

Lead Sponsor

Collaborator

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

Bill and Melinda Gates Foundation, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, 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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of preeclampsia
Secondary	Severity of preeclampsia
Secondary	Incidence of gestational hypertension or preeclampsia
Secondary	Frequency of abruptio placentae
Secondary	Incidence of preterm birth
Secondary	Incidence of small for gestational age
Secondary	Incidence of low birth weight infants
Secondary	Biomarker level correlation with preeclampsia

External Links

•   Global Network for Women's and Children's Health Research
•   RTI International