Cervical Insufficiency Clinical Trial
— CERCEI LBOfficial 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
Verified date | December 2021 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
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) |
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