Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04722536
Other study ID # 69HCL20_1088
Secondary ID 2020-A03187-32
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Recruiting NCT06122506 - Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage N/A
Unknown status NCT01482039 - Patient Attitudes Toward Ultrasound Measurement of Cervical Length N/A
Completed NCT05863481 - Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage
Completed NCT01114516 - Multifactorial Approach to Emergent Cerclage N/A
Recruiting NCT04688866 - Investigation Into the Microorganisms in Pregnant Women
Completed NCT02405455 - Cerclage vs Cervical Pessary in Women With Cervical Incompetence N/A
Recruiting NCT05220839 - Relation of the Area of Cerclage With Preterm Birth
Completed NCT04158401 - Cervical Stiffness Measurement in Cervical Insufficiency
Not yet recruiting NCT05512052 - Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study Phase 1