Status:
COMPLETED
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
Lead Sponsor:
Thomas Jefferson University
Conditions:
Premature Birth
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and witho...
Detailed Description
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (\<=25mm) and meeting all other eligibility...
Eligibility Criteria
Inclusion
- 18 year old or older
- Singleton pregnancy
- No prior SPTB or second trimester losses between 160 and 366 weeks
- TVU CL ≤25mm between 180 and 236 weeks
Exclusion
- Multiple pregnancy
- Prior SPTB or second trimester losses between 160 and 366 weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Rupture membranes
- Major fetal anomaly or aneuploidy
- Active vaginal bleeding
- Placenta previa and/or accreta
- Cervical dilation \>1.0 cm and/or visible membranes by pelvic exam
- Suspicion of chorioamnionitis
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03251729
Start Date
September 22 2017
End Date
February 20 2024
Last Update
April 19 2024
Active Locations (3)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
2
University of Naples Federico II
Naples, Italy
3
University Cattolica del S. Cuore
Rome, Italy