Cervical Cerclage Position Throughout the Pregnancy.

Not Applicable

Terminated

• Conditions: Cervix Uteri-Diseases
• Interventions: Diagnostic Test: Trans vaginal sonography; Diagnostic Test: Vaginal examination; Diagnostic Test: Speculum examination

• Registration Number: NCT03046654
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Cervical cerclage is an obstetric intervention used in women with poor obstetric histories. After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. .

Detailed Description

Cervical cerclage is an obstetric intervention used in women with poor obstetric histories due to late abortions, premature deliveries and painless dilatation. These 3 situations are usually due to cervical incompetence though can be caused by infection and other factors.

The cerclage is usually placed from 12-24 weeks of gestation depending on the indication and medical follow up during pregnancy. There are 2 methods for cerclage performance-McDonald and Shirodkar that have the same efficacy.

After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. Each follow up will include a vaginal examination and trans vaginal sonography. The trans vaginal sonography will examine total cervical length, funneling, and the cerclage's distance from the inner and outer os' of the cervix.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-08
• Study Start: 2017-03-15
• Primary Completion: 2020-03-01
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Women that have a cervical cerclage placed during pregnancy at the investigator's medical center.

Exclusion Criteria

• Women that do not require cervical cerclage.
• Women that had a cervical cerclage placed at a different medical center.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cervical cerclage	Trans vaginal sonography	Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.
Cervical cerclage	Vaginal examination	Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.
Cervical cerclage	Speculum examination	Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.

Primary Outcome Measures

Name	Time	Method
Gestational age at the time of delivery	Up to 9 months	Gestational age at the time of delivery

Secondary Outcome Measures

Name	Time	Method
Gestational age at the time of the removal of the cervical cerclage	Up to 9 months	Gestational age at the time of the removal of the cervical cerclage

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel