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Cervical Cerclage Position Throughout the Pregnancy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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. .

Condition or disease Intervention/treatment Phase
Cervix Uteri-Diseases Diagnostic Test: Trans vaginal sonography Diagnostic Test: Vaginal examination Diagnostic Test: Speculum examination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : August 31, 2020

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.




Primary Outcome Measures :
  1. Gestational age at the time of delivery [ Time Frame: Up to 9 months ]
    Gestational age at the time of delivery


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046654


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam Health Care Campus
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Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03046654    
Other Study ID Numbers: 0247-15-RMB
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Diseases