The Optimal Timing for Cerclage Removal

Respiratory Disease of A Newborn Clinical Trial

Official title:

The Optimal Timing for Cerclage Removal

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04151303
• Other study ID #: 0410-19-RMB
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2019
• Source: Rambam Health Care Campus
• Contact: Yaniv Zipori, M.D
• Phone: +972 58 7966963
• Email: y_zipori[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease of A Newborn
• Respiratory Tract Diseases

Intervention

Procedure:
• Cervical cerclage
Cervical cerclage and cervical cerclage removal

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cercalge removal and neonatal morbidity	Neonatal respiratory morbidity after cerclage removal	1 year
Secondary	The optimal timing for cerclage removal	Time interval between cerclage removal and gestational age of delivery.	1 year