Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial

17D.164

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

2017-09-22

2024-02-20

2024-02-20

Completed

Early phase I

93

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 93, 'type': 'ACTUAL'}}

2024-04-19