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Cervical Cerclage Position Throughout the Pregnancy.

Primary Purpose

Cervix Uteri-Diseases

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Trans vaginal sonography
Vaginal examination
Speculum examination
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervix Uteri-Diseases

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam health care campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cervical cerclage

Arm Description

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

Outcomes

Primary Outcome Measures

Gestational age at the time of delivery
Gestational age at the time of delivery

Secondary Outcome Measures

Gestational age at the time of the removal of the cervical cerclage
Gestational age at the time of the removal of the cervical cerclage

Full Information

First Posted
February 2, 2017
Last Updated
September 12, 2020
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03046654
Brief Title
Cervical Cerclage Position Throughout the Pregnancy.
Official Title
Cervical Cerclage Position Throughout Pregnancy, it's Distance From the Inner and Outer Cervical os', and Implications of the Position on Pregnancy Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in patient recruitment
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Uteri-Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical cerclage
Arm Type
Experimental
Arm Description
Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Trans vaginal sonography
Intervention Description
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'.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vaginal examination
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Speculum examination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational age at the time of delivery
Description
Gestational age at the time of delivery
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Gestational age at the time of the removal of the cervical cerclage
Description
Gestational age at the time of the removal of the cervical cerclage
Time Frame
Up to 9 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Cervical Cerclage Position Throughout the Pregnancy.

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