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

Not Applicable

Terminated

• Conditions: Mid Trimester Cervical Shortening
• Interventions: Procedure: McDonald cerclage placement; Drug: 17 hydroxyprogesterone caproate

• Registration Number: NCT00694967
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-07
• Study First Submitted QC: 2008-06-07
• Last Update Submitted: 2008-06-07
• Study First Posted: 2008-06-11
• Last Update Posted: 2008-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	McDonald cerclage placement	McDonald cerclage
2	17 hydroxyprogesterone caproate	17 hydroxyprogesterone caproate

Primary Outcome Measures

Name	Time	Method
The primary outcome was spontaneous preterm birth prior to 35 weeks gestation	11/2003 - 12/2006

Secondary Outcome Measures

Name	Time	Method
Obstetrical complications	11/2003 - 12/2006
Neonatal morbidity & mortality	11/2003 --12/2006

Trial Locations

Locations (1)

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States