Cervical Cerclage Position Throughout the Pregnancy.

NCT03046654 | Terminated

• 1 other identifier: 0247-15-RMB
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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. .

Conditions

Cervix Uteri-Diseases

Outcome Measures

Primary Outcomes (1)

• Gestational age at the time of delivery

  Gestational age at the time of delivery

  Up to 9 months

Secondary Outcomes (1)

• Gestational age at the time of the removal of the cervical cerclage

  Up to 9 months

Study Arms (1)

Cervical cerclage

EXPERIMENTAL

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

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

Interventions

Trans vaginal sonography DIAGNOSTIC_TEST

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'.

Cervical cerclage

Vaginal examination DIAGNOSTIC_TEST

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.

Cervical cerclage

Speculum examination DIAGNOSTIC_TEST

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.

Cervical cerclage

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women that have a cervical cerclage placed during pregnancy at the investigator's medical center.

You may not qualify if:

• Women that do not require cervical cerclage.
• Women that had a cervical cerclage placed at a different medical center.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Interventions

Gynecological Examination

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Roy Lauterbach, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 8, 2017
• Study Start: March 15, 2017
• Primary Completion: March 1, 2020
• Study Completion: August 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)