Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy

June 20, 2023 updated by: Abdallah Saleh, Ain Shams University
The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of the infertile woman. The number of hysterosalpingography examinations performed has significantly increased in recent years, likely due to the trend for women delaying pregnancy until later in life and the popularity of technical advances achieved in reproductive medicine.The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. The main purpose of the study is to evaluate the diagnostic role of HSG to early detect cesarean scar niche. To evaluate diagnostic role of hysterosalpingography (HSG) in cesarean scar niche at Early Cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital within 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

  • Egypt
      • Cairo, Egypt
        • Ain Shams U

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All women undergoing Office Hysteroscopy at Early cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital was checked to meet the inclusion criteria for the study.

Description

Inclusion Criteria

  • Age more than 18 years.
  • Previous history of cesarean delivery.
  • Cesarean scar niche confirmed by Hysteroscopy.
  • Premenopausal status

Exclusion Criteria:

  • Pregnancy.
  • Contrast allergy.
  • Active pelvic infection.
  • Medical history interfering with HSG.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean section niche appearance
Time Frame: baseline, pre-intervention
The ability of hysterosalpingography to detect the cesarean section niche appearance
baseline, pre-intervention

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

March 1, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AinG6/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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