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

June 7, 2008 updated by: Lehigh Valley Hospital

Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • LeHigh Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ultrasonographic evidence of premature dilatation of the internal os
  • Prolapse of the chorio-amniotic membranes into the endocervical canal
  • Functional cervical length less than 25mm
  • Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure

Exclusion Criteria:

  • Any fetal chromosomal or structural anomaly
  • Multiple gestation
  • Known allergy to progesterone
  • Ruptured membranes
  • Vaginal bleeding
  • Intra-amniotic infection (diagnosed clinically or by amniocentesis)
  • Prolapse of endocervical membranes beyond the external cervical os
  • Persistent uterine activity accompanied by cervical change
  • Obstetrically indicated delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
McDonald cerclage
Procedure: McDonald cerclage placement
Transcervical McDonald cerclage placement
Active Comparator: 2
17 hydroxyprogesterone caproate
Drug: 17 hydroxyprogesterone caproate
Weekly 250mg intramuscular injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome was spontaneous preterm birth prior to 35 weeks gestation
Time Frame: 11/2003 - 12/2006
11/2003 - 12/2006

Secondary Outcome Measures

Outcome Measure
Time Frame
Obstetrical complications
Time Frame: 11/2003 - 12/2006
11/2003 - 12/2006
Neonatal morbidity & mortality
Time Frame: 11/2003 --12/2006
11/2003 --12/2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lehigh Valley Hospital

Investigators

  • Principal Investigator: Orion Rust, M.D, LeHigh Valley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 7, 2008

First Submitted That Met QC Criteria

June 7, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2008

Last Update Submitted That Met QC Criteria

June 7, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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