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Isthmocele - Prediction, Prevention, Diagnosis, and Management

Isthmocele - Prediction, Prevention, Diagnosis, and Management

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04566575
Enrollment
27
Registered
2020-09-28
Start date
2020-09-30
Completion date
2022-03-02
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isthmocele

Keywords

Caesarean section, Myometrium, Hydrometra, transvaginal ultrasound, Isthmocele correction

Brief 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 surgery). This study is to investigate the effectiveness of the procedures used to treat isthmocele.

Interventions

OTHERtrans 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.

exploratory patient questionnaire regarding satisfaction after correction of isthmocele

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Myometrium thickness after isthmocele correction procedure (mm)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 proceduresingle 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 proceduresingle 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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026