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

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. Identifier: NCT00694967
Recruitment Status : Terminated (Interim analysis showed no difference in outcome between treatment groups.)
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
Information provided by:
Lehigh Valley Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Mid Trimester Cervical Shortening Procedure: McDonald cerclage placement Drug: 17 hydroxyprogesterone caproate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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
Study Start Date : November 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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 identifier (NCT number): NCT00694967

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

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Responsible Party: Orion Rust M.D., Lehigh Valley Hospital Identifier: NCT00694967     History of Changes
Other Study ID Numbers: 2003103
First Posted: June 11, 2008    Key Record Dates
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:
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17 alpha-Hydroxyprogesterone Caproate
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs