Status:
TERMINATED
A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix
Lead Sponsor:
Lehigh Valley Hospital
Conditions:
Mid Trimester Cervical Shortening
Eligibility:
FEMALE
Phase:
NA
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 the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00694967
Start Date
November 1 2003
End Date
December 1 2006
Last Update
June 11 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105