Cervical Cerclage Position Throughout the Pregnancy.

Rambam Health Care Campus

Status: Terminated

Conditions: Cervix Uteri-Diseases

Treatments: Diagnostic Test: Vaginal examination; Diagnostic Test: Trans vaginal sonography; Diagnostic Test: Speculum examination

Study type: Interventional

Funder types: Other

Identifiers

NCT03046654

0247-15-RMB

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Cervical cerclage

Experimental group

Description:

Women with a poor obstetric history that require cervical cerclage in order to avoid late abortion/early delivery.

Treatment:

Diagnostic Test: Vaginal examination

Diagnostic Test: Speculum examination

Diagnostic Test: Trans vaginal sonography