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Cervical Cerclage Position Throughout the Pregnancy.

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ClinicalTrials.gov Identifier: NCT03046654
Recruitment Status : Terminated (Difficulty in patient recruitment)
First Posted : February 8, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE February 2, 2017
First Posted Date  ICMJE February 8, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE March 15, 2017
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2017)
Gestational age at the time of delivery [ Time Frame: Up to 9 months ]
Gestational age at the time of delivery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2017)
Gestational age at the time of the removal of the cervical cerclage [ Time Frame: Up to 9 months ]
Gestational age at the time of the removal of the cervical cerclage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Cerclage Position Throughout the Pregnancy.
Official Title  ICMJE Cervical Cerclage Position Throughout Pregnancy, it's Distance From the Inner and Outer Cervical os', and Implications of the Position on Pregnancy Outcomes.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cervix Uteri-Diseases
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Cervical cerclage
Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.
Interventions:
  • Diagnostic Test: Trans vaginal sonography
  • Diagnostic Test: Vaginal examination
  • Diagnostic Test: Speculum examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 12, 2020)
7
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2017)
40
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03046654
Other Study ID Numbers  ICMJE 0247-15-RMB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ROY LAUTERBACH MD, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roy Lauterbach, MD Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP