A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix
Stopped early · Not applicable
Conditions studied: Mid Trimester Cervical Shortening
In brief
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.
Key facts
- Study ID
- NCT00694967
- Run by
- Lehigh Valley Hospital
- People needed
- 92
- Starts
- 2003-11-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2008-06-11
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Lehigh Valley Hospital — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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