Effectiveness of Cervico-isthmic Cerclage

Completed

• Conditions: Cerclage, Cervical; Cervical Insufficiency
• Interventions: Procedure: Cervico-isthmic cerclage

• Registration Number: NCT04722536
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Study Start: 2021-06-13
• Status Verified: 2021-12
• Primary Completion: 2021-12-11
• Study Completion: 2021-12-11
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervico-isthmic cerclage	Cervico-isthmic cerclage	Are included in this group the women who underwent cervico-isthmic cerclage between January 1, 2010 and April 1, 2019, in 3 hospitals of the Hospices Civils de Lyon, respecting the inclusion and exclusion criteria, to assess the primary and secondary outcomes before and after performing the cerclage.

Primary Outcome Measures

Name	Time	Method
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.	Day 0 (At Inclusion)	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.

Trial Locations

Locations (3)

Hôpital de la Croix Rousse - Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France

Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon; 🇫🇷 Bron, France