The Optimal Timing for Cerclage Removal

• Conditions: Respiratory Disease of A Newborn
• Interventions: Procedure: Cervical cerclage

• Registration Number: NCT04151303
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-02
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-02
• Last Update Submitted: 2019-11-02
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Study Start: 2019-12-01
• Primary Completion: 2020-08-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Singleton pregnancies
• Elective or emergent cerclage in the current pregnancy
• Cerclage that was removed after 36 weeks of pregnancy

Exclusion Criteria

• Multiple pregnancies
• Major congenital anomalies
• Cerclage removal before 36weeks of pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cerclage 4	Cervical cerclage	Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4
Cerclage 3	Cervical cerclage	Between 38-38.6 weeks' gestation - group 3
Cerclage 1	Cervical cerclage	Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1
Cerclage 2	Cervical cerclage	Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2

Primary Outcome Measures

Name	Time	Method
Cercalge removal and neonatal morbidity	1 year	Neonatal respiratory morbidity after cerclage removal

Secondary Outcome Measures

Name	Time	Method
The optimal timing for cerclage removal	1 year	Time interval between cerclage removal and gestational age of delivery.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel