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

Mid Trimester Cervical Shortening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00694967
• Other study ID #: 2003103
• Status: Terminated
• Phase: N/A
• First received: June 7, 2008
• Last updated: June 7, 2008
• Start date: November 2003
• Est. completion date: December 2006

Study information

• Verified date: June 2008
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mid Trimester Cervical Shortening

Intervention

Procedure:
• McDonald cerclage placement
Transcervical McDonald cerclage placement

Drug:
• 17 hydroxyprogesterone caproate
Weekly 250mg intramuscular injections

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lehigh Valley Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was spontaneous preterm birth prior to 35 weeks gestation		11/2003 - 12/2006	No
Secondary	Obstetrical complications		11/2003 - 12/2006	No
Secondary	Neonatal morbidity & mortality		11/2003 --12/2006	No