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

Premature Birth Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251729
• Other study ID #: 17D.164
• Status: Completed
• Phase: Phase 4
• Start date: September 22, 2017
• Est. completion date: February 20, 2024

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Procedure:
• Cervical cerclage
Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks

Drug:
• Vaginal progesterone
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples
Italy	University Cattolica del S. Cuore	Rome
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Countries where clinical trial is conducted

United States,  Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth <35 weeks	Incidence of spontaneous preterm birth less than 35 weeks	At delivery
Secondary	Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks		At delivery
Secondary	Mean gestational age at delivery		At delivery
Secondary	Histologically proven clinical chorioamnionitis		At delivery
Secondary	Neonatal outcomes: birth weight		At delivery
Secondary	Neonatal outcomes: low birth weight (<2500g),		At delivery
Secondary	Neonatal outcomes: admission to intensive care nursery		At delivery
Secondary	Neonatal outcomes: length of neonatal hospital admission		at least 30 days after delivery, up to 6 months after delivery
Secondary	Neonatal outcomes: respiratory distress syndrome		at least 30 days after delivery, up to 6 months after delivery
Secondary	Neonatal outcomes: IVH grade 3 or 4		at least 30 days after delivery, up to 6 months after delivery
Secondary	Neonatal outcomes: retinopathy of prematurity		at least 30 days after delivery, up to 6 months after delivery
Secondary	Neonatal outcomes: bronchopulmonary dysplasia		at least 30 days after delivery, up to 6 months after delivery
Secondary	Neonatal outcomes: neonatal mortality		28 days after delivery