Pregnancy Clinical Trial
Official title:
A Trial of Micronutrients and Adverse Pregnancy Outcomes
The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.
Status | Completed |
Enrollment | 8468 |
Est. completion date | July 2006 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - HIV negative - 12-26 weeks gestational age at screening visit |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health | Muhimbili University of Health and Allied Sciences |
Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fetal loss, low birth weight and pre-term birth. | Delivery | No | |
Secondary | Child morbidity and mortality; child growth | 12 months postpartum | No |
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