Cervical Cerclage Position Throughout the Pregnancy.

Cervical Cerclage Position Throughout Pregnancy, it's Distance From the Inner and Outer Cervical os', and Implications of the Position on Pregnancy Outcomes.

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. .

Study Overview

• Status: Terminated
• Conditions: Cervix Uteri-Diseases
• Intervention / Treatment: Diagnostic test: Trans vaginal sonography; Diagnostic test: Vaginal examination; Diagnostic test: Speculum examination

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cervical cerclage; Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.

Diagnostic test: Trans vaginal sonography; Trans vaginal sonography performed once every 4 weeks from the time of cerclage placement until the time of cerclage removal to evaluate cerclage position and distance from internal and external os'.; Diagnostic test: Vaginal examination; Vaginal examination performed once every 4 weeks from the time of cerclage placement until the time of cerclage removal to evaluate cervical conditions including cervical dilatation, cervical effacement and pressure on the cerclage.; Diagnostic test: Speculum examination; Speculum examination performed once every 4 weeks from the time of cerclage placement until the time of cerclage removal to evaluate cerclage position and vaginal bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at the time of delivery	Gestational age at the time of delivery	Up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at the time of the removal of the cervical cerclage	Gestational age at the time of the removal of the cervical cerclage	Up to 9 months

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: 0247-15-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No