Effectiveness of Cervico-isthmic Cerclage

Cervical Insufficiency Clinical Trial

— CERCEI LB  

Official title:

Effectiveness of CERvico-isthmic CErclage in Increasing the Rate of Live Births in Case of a History of Late Miscarriage and/or Premature Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722536
• Other study ID #: 69HCL20_1088
• Secondary ID: 2020-A03187-32
• Status: Completed
• Start date: June 13, 2021
• Est. completion date: December 11, 2021

Study information

• Verified date: December 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares the rate of live births before and after cervico-isthmic cerclage in 3 hospitals in the last 10 years. The hypothesis is that cerclage significantly increases the rate of live births in women with cervical insufficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 11, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of premature delivery or late miscarriage unrelated to maternal pathology, chorioamnionitis, fetal or placental pathology
• Patient aged over 18 at the time of the phone call
• Cerclage performed according to the Benson technique verified on the operative report
• Cerclage performed in one of the 3 obstetric gynecology departments of the CHU de Lyon (Lyon Sud, Croix Rousse and HFME) between January 1, 2010 and April 1, 2019

Exclusion Criteria:

• History of trachelectomy
• Surgical technique not specified or not deductible from the operating report
• Refusal to participate in the study
• Patient under legal protection

Related Conditions & MeSH terms

• Cerclage, Cervical
• Cervical Insufficiency
• Uterine Cervical Incompetence

Intervention

Procedure:
• Cervico-isthmic cerclage
There is no intervention in this study. It's an observational retrospective study, before/after.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon	Bron
France	Hôpital de la Croix Rousse - Hospices Civils de Lyon	Lyon
France	Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of live birth = 24 weeks of gestation or before 24 weeks of gestation with active neonatal intensive care, among pregnancies progressing after 14 weeks of gestation.	We collect the data necessary to assess the outcomes in the medical charts. When data is missing, we will call patients (telephone interview) and ask them a few questions related to their gynecological and obstetric history.	Day 0 (At Inclusion)