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Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix

NCT02357394 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-10-31

Study results available
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Summary

The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.

Conditions

  • Premature Birth

Interventions

DEVICE

Arabin Pessary

Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Gene Lee, MD

    lead OTHER

Principal Investigators

  • Gene T Lee, MD · University of Kansas Medical Center

  • Eugene Y Chang, MD · Medical University of South Carolina

  • Carl P Weiner, MD, MBA · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-06-06
Completion
2019-04-01
FDA Device
Yes

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 NCT02357394 on ClinicalTrials.gov