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

Phase 4 Completed 93 enrolled Thomas Jefferson University

RandomizedParallel-groupOpen-labelTreatment

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 without prior spontaneous preterm birth

Timeline

Start: 2017-09-22
Primary completion: 2024-02-20
Completion: 2024-02-20

Publications

Background Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.
Boelig RC, Tersigni C, Di Simone N, Saccone G, Facchinetti F, Scambia G, Berghella V. Cerclage in singleton pregnancies with no prior spontaneous preterm birth and short cervix: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Apr;7(4):101602. doi: 10.1016/j.ajogmf.2025.101602. Epub 2025 Jan 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Progesterone	Other / unclassified	90 mg	Other
Background	Progesterone	Other / unclassified	200 mg	Other

Indications

No indication recorded.