Effectiveness of Cervico-isthmic Cerclage

NCT04722536 | Completed

• 2 other identifiers: 69HCL20_10882020-A03187-32
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Cerclage, Cervical; Cervical Insufficiency

Keywords

cervico-isthmic cerclage; cerclage; cervico-isthmic; cervical insufficiency; miscarriage; prematurity

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Procedure: Cervico-isthmic cerclage

Interventions

Cervico-isthmic cerclage PROCEDURE

There is no intervention in this study. It's an observational retrospective study, before/after.

Cervico-isthmic cerclage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had cervico-isthmic cerclage between January 1, 2010 and April 1, 2019, in 3 University Hospitals of Lyon (Lyon Sud Hospital, HFME Hospital and Croix-Rousse Hospital).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon

Bron, 69500, France

Location

Hôpital de la Croix Rousse - Hospices Civils de Lyon

Lyon, 69004, France

Location

Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Uterine Cervical Incompetence; Abortion, Spontaneous; Premature Birth

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Pregnancy Complications; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• DEBORAH GAVANIER, MD

  Service de gynécologie-obstétrique - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: June 13, 2021
• Primary Completion: December 11, 2021
• Study Completion: December 11, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

FR (3)