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A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix

NCT02901626 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2023-06-22

Study results available
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Summary

The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.

Conditions

  • Short Cervix
  • Preterm Delivery

Interventions

DEVICE

Arabin Cervical Pessary

The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm

Sponsors & Collaborators

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

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Rebecca Clifton, Ph.D. · George Washington University Biostatistics Center

  • Monica Longo, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Matthew Hoffman, MD · Christiana Care Health Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2022-04-02
Completion
2022-05-10
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 NCT02901626 on ClinicalTrials.gov