Effectiveness of Cervico-isthmic Cerclage

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.

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Key information

Conditions

Cerclage, Cervical Abortion, Habitual Abortion, Spontaneous Cervical Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Incompetence Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervico-isthmic cerclage

Procedure

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

Primary outcomes

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: CERCEI LB

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Jan 25, 2021
Registry last updated: Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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