Cervical Cerclage Position Throughout the Pregnancy.

Cervix Uteri-Diseases Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03046654
• Other study ID #: 0247-15-RMB
• Status: Terminated
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 31, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Uteri-Diseases
• Uterine Diseases

Intervention

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'.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at the time of delivery	Gestational age at the time of delivery	Up to 9 months
Secondary	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