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A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix

NCT00694967 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2008-06-11

No results posted yet for this study

Summary

We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.

Conditions

  • Mid Trimester Cervical Shortening

Interventions

PROCEDURE

McDonald cerclage placement

Transcervical McDonald cerclage placement

DRUG

17 hydroxyprogesterone caproate

Weekly 250mg intramuscular injections

Sponsors & Collaborators

  • Lehigh Valley Hospital

    lead OTHER

Principal Investigators

  • Orion Rust, M.D · Lehigh Valley Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2006-12-31
Completion
2006-12-31

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 NCT00694967 on ClinicalTrials.gov