Evaluation Of The Diagnostic Role Of Hysterosalpingograph... | NCT05911815

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

NCT05911815

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Cesarean Section Complications

Interventions

hysterosalpingography

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Jun 9, 2023

First Submission Date that Met QC Criteria

Jun 20, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided