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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03046654

Enrollment

Registered

2017-02-08

Start date

2017-03-15

Completion date

2020-08-31

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Uteri-Diseases

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. .

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.

Interventions

DIAGNOSTIC_TESTTrans 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_TESTVaginal 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_TESTSpeculum 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Gestational age at the time of delivery	Up to 9 months	Gestational age at the time of delivery

Secondary

Measure	Time frame	Description
Gestational age at the time of the removal of the cervical cerclage	Up to 9 months	Gestational age at the time of the removal of the cervical cerclage

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026