RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

NCT00097110 | Completed Phase 3 DMC

• 2 other identifiers: GN 05U01HD040565
• Study Type: interventional
• Target: 734
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia; Eclampsia; HELLP Syndrome; Pregnancy

Keywords

Vitamin C; Vitamin E; Preeclampsia; Antioxidants; Global Network; Preterm birth; Low birth weight infants; Brazil; Brasil; Maternal and child health; International; Women's health

Outcome Measures

Primary Outcomes (1)

• Incidence of preeclampsia

Secondary Outcomes (7)

• Severity of preeclampsia

• Incidence of gestational hypertension or preeclampsia

• Frequency of abruptio placentae

• Incidence of preterm birth

• Incidence of small for gestational age

Interventions

Vitamin C and E DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Global Network for Women's and Children's Health Research: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• National Cancer Institute (NCI): collaborator
• RTI International: collaborator
• University of Cincinnati: collaborator
• Universidade Federal de Pernambuco: collaborator
• Feculdade de Medicina da Universidade de Sao Paulo - Brasil: collaborator
• Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil: collaborator
• University of Campinas, Brazil: collaborator
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Location

Related Publications (2)

• Spinnato JA 2nd, Freire S, Pinto e Silva JL, Rudge MV, Martins-Costa S, Koch MA, Goco N, Santos Cde B, Cecatti JG, Costa R, Ramos JG, Moss N, Sibai BM. Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis. Am J Obstet Gynecol. 2008 Oct;199(4):433.e1-8. doi: 10.1016/j.ajog.2008.07.011.

  PMID: 18928997 DERIVED

• Spinnato JA 2nd, Freire S, Pinto E Silva JL, Cunha Rudge MV, Martins-Costa S, Koch MA, Goco N, Santos Cde B, Cecatti JG, Costa R, Ramos JG, Moss N, Sibai BM. Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1311-8. doi: 10.1097/01.AOG.0000289576.43441.1f.

  PMID: 18055726 DERIVED

Related Links

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

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; HELLP Syndrome; Premature Birth

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Joseph A. Spinnato, M.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2004
• First Posted: November 18, 2004
• Study Start: July 1, 2003
• Study Completion: December 1, 2006
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

BR (1)