Skip to main content
OpenTrials
Completed

NCT Number: NCT04566575

Isthmocele - Prediction, Prevention, Diagnosis, and Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Isthmocele

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Basel, Women's Hospital

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 questionnaire

Other

exploratory patient questionnaire regarding satisfaction after correction of isthmocele

Primary outcomes

  1. 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)

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 28, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.