NCT03251729

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

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 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

Conditions

• Premature Birth

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-22
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2017-08-16
• Last updated: 2024-04-19

Locations

3 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated drug study