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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05911815
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications	Radiation: hysterosalpingography

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: Aug 1, 2022
• Actual Study Completion Date: Jun 1, 2023

Outcome Measures

Primary Outcome Measures

1. Cesarean section niche appearance [baseline, pre-intervention]

   The ability of hysterosalpingography to detect the cesarean section niche appearance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams U	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdallah Saleh, Resident at gynecology department, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05911815
• Other Study ID Numbers: AinG6/2023
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 22, 2023