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.)
Sponsor:
Information provided by:
Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00694967
First received: June 7, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obstetrical complications [ Time Frame: 11/2003 - 12/2006 ] [ Designated as safety issue: No ]
  • Neonatal morbidity & mortality [ Time Frame: 11/2003 --12/2006 ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694967

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

No publications provided

Responsible Party: Orion Rust M.D., Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00694967     History of Changes
Other Study ID Numbers: 2003103
Study First Received: June 7, 2008
Last Updated: June 7, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on July 22, 2014