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
|Condition or disease||Intervention/treatment||Phase|
|Cervix Uteri-Diseases||Diagnostic Test: Trans vaginal sonography Diagnostic Test: Vaginal examination Diagnostic Test: Speculum examination||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Gestational age at the time of delivery [ Time Frame: Up to 9 months ]Gestational age at the time of delivery
- 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
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
|Rambam health care campus|
|Principal Investigator:||Roy Lauterbach, MD||Rambam Health Care Campus|