drugset / Trial / NCT00097110
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
Phase 3
Completed
734 enrolled
NICHD Global Network for Women's and Children's Health
Bill and Melinda Gates Foundation · collabFaculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil · collabFeculdade de Medicina da Universidade de Sao Paulo - Brasil · collabFogarty International Center of the National Institute of Health · collabGlobal Network for Women's and Children's Health Research · collabHospital de Clinicas de Porto Alegre · collabNational Cancer Institute (NCI) · collabNational Center for Complementary and Integrative Health (NCCIH) · collabNational Institute of Dental and Craniofacial Research (NIDCR) · collabRTI International · collabUniversidade Federal de Pernambuco · collabUniversity of Campinas, Brazil · collabUniversity of Cincinnati · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2003-07
- Primary completion
- —
- Completion
- 2006-12
Outcome
Missed primary endpoint
paper This trial failed to demonstrate a benefit of antioxidant supplementation in reducing the rate of preeclampsia among patients with chronic hypertension and/or prior preeclampsia. PMID 18055726 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin C | Other / unclassified | 1000 mg | — |
| Subject | Vitamin E | Other / unclassified | 400 iu | — |