Isthmocele - Prediction, Prevention, Diagnosis, and Management

March 14, 2022 updated by: University Hospital, Basel, Switzerland
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • University Hospital Basel, Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients undergoing isthmocele correction surgery within the period from 01.01.2017 to 31.12.2020 at the University Hospital Basel, Women's Hospital

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
single time-point at baseline (approx. 10 minutes)
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
single time-point at baseline (approx. 10 minutes)
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)
single time-point at baseline (approx. 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Viola Heinzelmann, Prof. Dr. med., University Hospital Basel, Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-01874; sp20Fellmann

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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