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

This study has been terminated.
(Interim analysis showed no difference in outcome between treatment groups.)
ClinicalTrials.gov Identifier:
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lehigh Valley Hospital
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.

Condition Intervention
Mid Trimester Cervical Shortening Procedure: McDonald cerclage placement Drug: 17 hydroxyprogesterone caproate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy

Resource links provided by NLM:

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • The primary outcome was spontaneous preterm birth prior to 35 weeks gestation [ Time Frame: 11/2003 - 12/2006 ]

Secondary Outcome Measures:
  • Obstetrical complications [ Time Frame: 11/2003 - 12/2006 ]
  • Neonatal morbidity & mortality [ Time Frame: 11/2003 --12/2006 ]

Enrollment: 92
Study Start Date: November 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694967

United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Sponsors and Collaborators
Lehigh Valley Hospital
Principal Investigator: Orion Rust, M.D Lehigh Valley Hospital
  More Information

Responsible Party: Orion Rust M.D., Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00694967     History of Changes
Other Study ID Numbers: 2003103
First Submitted: June 7, 2008
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by Lehigh Valley Hospital:
short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone

Additional relevant MeSH terms:
17-alpha-hydroxy-progesterone caproate
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs