Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097110
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2004-11-17
Brief Title:
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 preeclampsiaeclampsia
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 preeclampsiaeclampsia 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 preeclampsiaeclampsia 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 005 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
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 preeclampsiaeclampsia 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD040565 | NIH | None | httpsreporternihgovquickSearchU01HD040565 |