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The Effects of Aspirin in Gestation and Reproduction

NCT00467363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1228

Last updated 2017-02-03

Study results available
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Summary

The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.

Conditions

  • Birth
  • Spontaneous Abortion

Interventions

DRUG

acetylsalicylic-acid (aspirin)

81mg of low-dose aspirin plus 400micrograms of folic acid.

DIETARY_SUPPLEMENT

Folic acid

400micrograms of folic acid.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Enrique F Schisterman, PhD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Jean Wactawski-Wende, PhD · University at Buffalo

  • Robert Silver, MD · University of Utah

  • Noya Galai, PhD · University of Haifa

  • Janet Townsend, M.D. · The Commonwealth Medical College

  • Anne Lynch, M.D. · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00467363 on ClinicalTrials.gov