NCT03046654

Cervical Cerclage Position Throughout the Pregnancy.

Cervical Cerclage Position Throughout Pregnancy, it's Distance From the Inner and Outer Cervical os', and Implications of the Position on Pregnancy Outcomes.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervix Uteri-Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-15
• Primary completion: 2020-03-01
• Completion: 2020-08-31
• First posted: 2017-02-08
• Last updated: 2020-09-16

Locations

1 site across 1 country: Israel