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Clinical Trials/NCT00197548
NCT00197548
Completed
Phase 3

A Trial of Micronutrients and Adverse Pregnancy Outcomes

Harvard School of Public Health (HSPH)0 sites8,468 target enrollmentAugust 2001

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Harvard School of Public Health (HSPH)
Enrollment
8468
Primary Endpoint
Fetal loss, low birth weight and pre-term birth.
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Detailed Description

Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. 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. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.

Registry
clinicaltrials.gov
Start Date
August 2001
End Date
July 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

  • HIV negative
  • 12-26 weeks gestational age at screening visit

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fetal loss, low birth weight and pre-term birth.

Time Frame: Delivery

Secondary Outcomes

  • Child morbidity and mortality; child growth(12 months postpartum)

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