Phase 3
N=110
Antioxidant Supplementation in Pregnant Women
Pregnant Women · Preeclampsia
Bottom Line
View on ClinicalTrials.gov: NCT01232205 ↗Enrolled (actual)
110
Serious AEs
—
Results posted
Dec 2010
Primary outcome: Primary: Preeclampsia
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- micronutrient antioxidant (Dietary_supplement); Control (Dietary_supplement)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Showa University
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preeclampsia |
1; 8 | — |
| PRIMARY Preeclampsia |
1; 8 | — |
| SECONDARY Cell-free mRNA |
— | — |
Summary
The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.
Eligibility Criteria
Inclusion Criteria
- pregnant women with 8-12 weeks of gestation
Exclusion Criteria
- known multiple pregnancy
- known fetal anomaly
- known thrombophilia
- known infections and mola hydatidosa
- chronic renal failure
- uncontrolled hypertension
- known placental abnormalities
- documented uterine bleeding within a week of screening
- uterine malformation
- history of medical and metabolic complication such as heart disease or diabetes
Data sourced from ClinicalTrials.gov (NCT01232205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.