Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix

Completed · Phase 4

Conditions studied: Premature Birth

In brief

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 without prior spontaneous preterm birth

Key facts

Study ID

NCT03251729

Run by

Thomas Jefferson University

People needed

93

Starts

2017-09-22

Expected to finish

2024-02-20

Last updated by the study team

2024-04-19

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• University of Naples Federico II — Naples, Italy
• University Cattolica del S. Cuore — Rome, Italy

Full record on ClinicalTrials.gov

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