Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

Phase 2

Completed

• Conditions: Preeclampsia

• Registration Number: NCT00388856
• Lead Sponsor: Showa University

Brief Summary

The purpose of this study is to investigate antioxidants supplementation in pregnant women with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy outcome in randomized prospective study.

Detailed Description

Preeclampsia still remains a leading cause of feto-maternal mortality and morbidity in developed and developing world. Despite of intensive research, the underlying pathologic mechanisms of this disease remain elusive. It has been agreed that incomplete or absent transformation of spiral arteries by replacing endothelial cells and mural vascular smooth muscle cells has been observed in the placental bed of preeclamptic patients and severe cases of intrauterine growth restriction. Oxidative stress has been proposed as a link between these mechanisms. However, it has been demonstrated by two large studies that antioxidant supplementation does not reduce the risk of preeclampsia. Our initial study has been shown that antioxidant supplementation may be reduce the risk of preeclampsia in pregnant women with low antioxidant status.

Comparison(s): adverse pregnancy outcome between vitamin C and E given and placebo given to pregnant women with low antioxidant status at 10-12 weeks gestation age

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Status Verified: 2007-03
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-16
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Agree to consent form, and consent to protocol of research
• Known healthy singleton 6-10 weeks pregnant women

Exclusion Criteria

• Blood pressure > 135/85
• Proteinuria
• History or current use of anti-hypertensive medication or diuretics
• Use of vitamins C > 150 mg and/or E > 75 IU per day
• Pregestational diabetes
• Known placental abnormalities.
• Current pregnancy is a result of in vitro fertilization
• Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs
• Known fetal abnormalities
• Documented uterine bleeding within a week of screening
• Uterine malformations
• History of medical complications
• Illicit drug or alcohol abuse during current pregnancy
• Intent to deliver elsewhere
• Known psychologic problems.
• Participating in another interventional study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
preeclampsia cases

Secondary Outcome Measures

Name	Time	Method
adverse pregnancy outcome

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta, Indonesia