Preeclampsia
Conditions
Keywords
antioxidant supplementation, preeclampsia, prevention
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
Interventions
DRUGVitamin C 1000mg and E 400IU
Sponsors
Indonesia University
Showa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| preeclampsia cases | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse pregnancy outcome | — |
Countries
Indonesia
Outcome results
None listed