TerminatedNot Applicable

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

Stopped: Interim analysis showed no difference in outcome between treatment groups.

United States92 participantsStarted 2003-11

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The primary outcome was spontaneous preterm birth prior to 35 weeks gestation

Timeframe: 11/2003 - 12/2006

Trial details

NCT IDNCT00694967

SponsorLehigh Valley Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-12

View on ClinicalTrials.gov More Mid Trimester Cervical Shortening trials