NCT04151303

The Optimal Timing for Cerclage Removal

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery

Detailed description

The optimal timing of cervical cerclage removal is yet unclear. In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/ Primary outcome: Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks). Secondary outcomes: Time interval between cerclage removal and gestational age of delivery.

Conditions

• Respiratory Disease of A Newborn

Interventions

Type	Name	Description
PROCEDURE	Cervical cerclage	Cervical cerclage and cervical cerclage removal

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-08-01
• Completion: 2021-01-01
• First posted: 2019-11-05
• Last updated: 2019-11-05

Locations

1 site across 1 country: Israel