Cerclage, CervicalCERCEI LBNCT04722536
Effectiveness of Cervico-isthmic Cerclage
An observational study of Cerclage, Cervical and Cervical Insufficiency, run by Hospices Civils de Lyon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cerclage, Cervical, Cervical Insufficiency
- What is being tested?
- Cervico-isthmic cerclage
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Jun 2021to 11 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- History of trachelectomy
- Surgical technique not specified or not deductible from the operating report
- Refusal to participate in the study
- Patient under legal protection
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon
Bron, 69500
Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, 69004
Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official 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
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
- Being tested
- Cervico-isthmic cerclage
- Keywords
- cervico-isthmic cerclage, cerclage, cervico-isthmic, cervical insufficiency, miscarriage, prematurity
- Medical subject headings
- Uterine Cervical Incompetence, Abortion, Spontaneous, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervico-isthmic cerclageProcedure or surgery
There is no intervention in this study. It's an observational retrospective study, before/after.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cervico-isthmic cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (At Inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start13 Jun 2021
- Primary completion11 Dec 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerclage, CervicalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEBORAH GAVANIER, MD, Principal investigator, Service de gynécologie-obstétrique - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722536
- Sponsor's protocol ID
- 69HCL20_1088
- Other IDs
- 2020-A03187-32
- Acronym
- CERCEI LB
- Status last verified
- Dec 2021
- First submitted
- 20 Jan 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04722536
- Acronym / sponsor ID
- CERCEI LB / 69HCL20_1088
- Conditions
- Cerclage, Cervical, Cervical Insufficiency
- Keywords
- cervico-isthmic cerclage, cerclage, cervico-isthmic, cervical insufficiency, miscarriage, prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Jun 2021 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervico-isthmic cerclage | – | Procedure: Cervico-isthmic cerclageAre 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- History of trachelectomy
- Surgical technique not specified or not deductible from the operating report
- Refusal to participate in the study
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervico-isthmic cerclageThere is no intervention in this study. It's an observational retrospective study, before/after. | Procedure or surgery | Cervico-isthmic cerclage |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DEBORAH GAVANIER, MD principal investigator
Service de gynécologie-obstétrique - Centre Hospitalier Lyon Sud
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerclage, Cervical and Cervical Insufficiency, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.