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

NCT05911815 | Completed FDA Device

• 1 other identifier: AinG6/2023
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Cesarean section niche appearance

  The ability of hysterosalpingography to detect the cesarean section niche appearance

  baseline, pre-intervention

Interventions

hysterosalpingography RADIATION

hysterosalpingogram (HSG) is an X-ray visualization of the lumen of the uterus and fallopian tubes, which can detect abnormalities including blockage, polyps, and salinities

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams U

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at gynecology department

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: March 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)