Status:
COMPLETED
Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Lead Sponsor:
Showa University
Collaborating Sponsors:
Indonesia University
Conditions:
Preeclampsia
Eligibility:
FEMALE
17-45 years
Phase:
PHASE2
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 randomiz...
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 disea...
Eligibility Criteria
Inclusion
- Agree to consent form, and consent to protocol of research
- Known healthy singleton 6-10 weeks pregnant women
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00388856
Start Date
October 1 2006
End Date
February 1 2010
Last Update
February 17 2010
Active Locations (1)
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1
Cipto Mangunkusumo National Hospital
Jakarta, Jakarta Special Capital Region, Indonesia, 10430