The Optimal Timing for Cerclage Removal

Rambam Health Care Campus

Status: Unknown

Conditions: Respiratory Disease of A Newborn

Treatments: Procedure: Cervical cerclage

Study type: Observational

Funder types: Other

Identifiers

NCT04151303

0410-19-RMB

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 4 patient groups

Cerclage 1

Description:

Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1

Treatment:

Procedure: Cervical cerclage

Cerclage 2

Description:

Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2

Treatment:

Procedure: Cervical cerclage

Cerclage 3

Description:

Between 38-38.6 weeks' gestation - group 3

Treatment:

Procedure: Cervical cerclage

Cerclage 4

Description:

Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4

Treatment:

Procedure: Cervical cerclage