IsthmoceleNCT04566575
Isthmocele - Prediction, Prevention, Diagnosis, and Management
An observational study of Isthmocele, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
An Isthmocele is a scar defect or uterine niche that develops in the myometrium due to an inadequate healing process at the site of the caesarean section incision. The management of isthmocele is not standardized and a correction typically involves invasive procedures (hysteroscopy/resectoscopy, laparoscopy, vaginal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Isthmocele
- What is being tested?
- trans vaginal ultrasound (TVUS) and patient questionnaire
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Sep 2020to 2 Mar 2022
- 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 underwent surgery for isthmocele at the University Hospital Basel between 01.01.2017 and 31.12.2020. Time interval from the operation performed to the study-specific consultation has a maximum of 4 years.
Who may be able to join
- Patients undergoing isthmocele correction surgery within the period from 01.01.2017 to 31.12.2020 at the University Hospital Basel, Women's Hospital
Who cannot join
- Missing information on the preoperative initial situation (preoperative myometrium thickness, lack of imaging via TVUS)
- Missing information on key characteristics that are important in the collection of retrospective data analysis (e.g. data on the previous caesarean section)
- Inability to give an informed consent
- Lack of German language skills
Trial locations and contacts
1 site in 1 country.
About this study
An Isthmocele is a scar defect or uterine niche that develops in the myometrium due to an inadequate healing process at the site of the caesarean section incision. The management of isthmocele is not standardized and a correction typically involves invasive procedures (hysteroscopy/resectoscopy, laparoscopy, vaginal surgery). This study is to investigate the effectiveness of the procedures used to treat isthmocele.
- Conditions
- Isthmocele
- Being tested
- trans vaginal ultrasound (TVUS), patient questionnaire
- Keywords
- Caesarean section, Myometrium, Hydrometra, transvaginal ultrasound, Isthmocele correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans vaginal ultrasound (TVUS)Other
In the TVUS, the residual myometrium is determined after surgery and the appearance of new cysts in the area of the caesarian section scar is assessed.
patient questionnaireOther
exploratory patient questionnaire regarding satisfaction after correction of isthmocele
What is being measured
The primary outcome is the main question the study is designed to answer.
Myometrium thickness after isthmocele correction procedure (mm)
Myometrium thickness after isthmocele correction procedure (mm), compared to myometrium thickness before isthmocele correction procedure, measured by TVUS (in mm)
Measured: single time-point at baseline (approx. 10 minutes)
Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure
Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure, measured by TVUS and compared to number of cysts before isthmocele correction procedure
Measured: single time-point at baseline (approx. 10 minutes)
Patient satisfaction after isthmocele correction procedure
Patient satisfaction after isthmocele correction procedure, analysed by explorative questionnaire ( ranging from a = very satisfied to f = absolutely not satisfied)
Measured: single time-point at baseline (approx. 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start30 Sep 2020
- Primary completion31 Dec 2021
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viola Heinzelmann, Prof. Dr. med., Principal investigator, University Hospital Basel, Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566575
- Sponsor's protocol ID
- 2020-01874; sp20Fellmann
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2020
- Last updated
- 15 Mar 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 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isthmocele - Prediction, Prevention, Diagnosis, and Management
- ClinicalTrials.gov ID
- NCT04566575
- Acronym / sponsor ID
- 2020-01874; sp20Fellmann
- Conditions
- Isthmocele
- Keywords
- Caesarean section, Myometrium, Hydrometra, transvaginal ultrasound, Isthmocele correction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 28 Sep 2020 (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.
An Isthmocele is a scar defect or uterine niche that develops in the myometrium due to an inadequate healing process at the site of the caesarean section incision. The management of isthmocele is not standardized and a correction typically involves invasive procedures (hysteroscopy/resectoscopy, laparoscopy, vaginal surgery). This study is to investigate the effectiveness of the procedures used to treat isthmocele.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery for isthmocele at the University Hospital Basel between 01.01.2017 and 31.12.2020. Time interval from the operation performed to the study-specific consultation has a maximum of 4 years.
Key inclusion criteria (1 listed)
- Patients undergoing isthmocele correction surgery within the period from 01.01.2017 to 31.12.2020 at the University Hospital Basel, Women's Hospital
Key exclusion criteria (4 listed)
- Missing information on the preoperative initial situation (preoperative myometrium thickness, lack of imaging via TVUS)
- Missing information on key characteristics that are important in the collection of retrospective data analysis (e.g. data on the previous caesarean section)
- Inability to give an informed consent
- Lack of German language skills
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 |
|---|---|---|
| trans vaginal ultrasound (TVUS)In the TVUS, the residual myometrium is determined after surgery and the appearance of new cysts in the area of the caesarian section scar is assessed. | Other | – |
| patient questionnaireexploratory patient questionnaire regarding satisfaction after correction of isthmocele | Other | – |
Primary outcome
Myometrium thickness after isthmocele correction procedure (mm)
Time frame: single time-point at baseline (approx. 10 minutes)
Myometrium thickness after isthmocele correction procedure (mm), compared to myometrium thickness before isthmocele correction procedure, measured by TVUS (in mm)
Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure
Time frame: single time-point at baseline (approx. 10 minutes)
Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure, measured by TVUS and compared to number of cysts before isthmocele correction procedure
Patient satisfaction after isthmocele correction procedure
Time frame: single time-point at baseline (approx. 10 minutes)
Patient satisfaction after isthmocele correction procedure, analysed by explorative questionnaire ( ranging from a = very satisfied to f = absolutely not satisfied)
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 15 Mar 2022.
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Impact of a Bladder Flap on Cesarean Scar Niche Development
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Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
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The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction
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Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
Isthmocele
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.
Viola Heinzelmann, Prof. Dr. med. principal investigator
University Hospital Basel, Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isthmocele, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Myometrium thickness after isthmocele correction procedure (mm) (time frame: single time-point at baseline (approx. 10 minutes)). The study lists 3 primary outcomes in all. 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 15 Mar 2022.