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

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lehigh Valley Hospital
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate

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.