The Optimal Timing for Cerclage Removal

NCT04151303 | Unknown DMC

• 1 other identifier: 0410-19-RMB
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Disease of A Newborn

Keywords

RDS; CERCLAGE; CERVIX INSUFFICIENCY

Outcome Measures

Primary Outcomes (1)

• Cercalge removal and neonatal morbidity

  Neonatal respiratory morbidity after cerclage removal

  1 year

Secondary Outcomes (1)

• The optimal timing for cerclage removal

  1 year

Study Arms (4)

Cerclage 1

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

Procedure: Cervical cerclage

Cerclage 2

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

Procedure: Cervical cerclage

Cerclage 3

Between 38-38.6 weeks' gestation - group 3

Procedure: Cervical cerclage

Cerclage 4

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

Procedure: Cervical cerclage

Interventions

Cervical cerclage PROCEDURE

Cervical cerclage and cervical cerclage removal

Cerclage 1; Cerclage 2; Cerclage 3; Cerclage 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

\- Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Interventions

Cerclage, Cervical

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yaniv Zipori, M.D

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaniv Zipori, M.D

CONTACT

+972 58 7966963; y_zipori@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: November 5, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: January 1, 2021
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

IL (1)