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Ultrasound-indicated Cerclage to Prevent Premature Birth in High-risk Women

NCT00059683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-09-30

No results posted yet for this study

Summary

Pregnant women who have a shortened cervix and have previously had a premature baby are at increased risk for having another premature baby. This study will determine whether reinforcing the cervix with a surgical stitch can reduce the chance of a premature birth.

Conditions

  • Labor, Premature

Interventions

PROCEDURE

cervical cerclage

Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

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

    lead NIH

Principal Investigators

  • John Owen, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2007-11-30
Completion
2009-10-31

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 NCT00059683 on ClinicalTrials.gov