NCT05125692

Brief Summary

20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

November 18, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

September 15, 2021

Last Update Submit

November 6, 2021

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • myometrial thickness in supracervical area

    the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively

    at 1 month postoperative

Study Arms (1)

women with symptomatic post cesarean Istmocele

OTHER

vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques

Procedure: vaginal surgical repair of isthmocele

Interventions

vaginal surgical repair of isthmocelePROCEDURE

after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach

women with symptomatic post cesarean Istmocele

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women diagnosed with symptomatic post cesarean isthmocele.
  • should present with abnormal uterine bleeding .

You may not qualify if:

  • presence of any other uterine pathology,
  • presence of adnexal pathology,
  • presence of malignancies,
  • presence of pregnancy,
  • presence of infection in the lower genital tract ,
  • general cause of bleeding
  • women not accepting the procedure,
  • women not consented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlya Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

osama M Warda, MD

CONTACT

01066153212osamawarda@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: WOMEN IN CHILDBEARING PERIOD WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

November 18, 2021

Study Start

September 4, 2021

Primary Completion

August 20, 2022

Study Completion

December 20, 2022

Last Updated

November 18, 2021

Record last verified: 2021-09

Locations

EG(1)