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Effectiveness of Cervico-isthmic Cerclage

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04722536
Acronym
CERCEI LB
Enrollment
45
Registered
2021-01-25
Start date
2021-06-13
Completion date
2021-12-11
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerclage, Cervical, Cervical Insufficiency

Keywords

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

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.

Interventions

PROCEDURECervico-isthmic cerclage

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026