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Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

NCT06529952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-07-31

No results posted yet for this study

Summary

Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. Dehiscence is defined as at least 80% myometrial thinning.

The aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.

Conditions

  • Cesarean Scar Defect

Interventions

PROCEDURE

hysteroscopic surgery by resection and endocoagulation

resection of lower edge, resection of upper edge and endocoagulation

PROCEDURE

hysteroscopic surgery by endocoagulation only

hysteroscopic endocoagulation to the base of the niche by roller ball

DRUG

hormonal treatment

using 3rd generation contraceptive pills

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2022-12-01
Completion
2023-02-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06529952 on ClinicalTrials.gov