Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in Detection of Ceserean Section Niche
1 other identifier
interventional
2
0 countries
N/A
Brief Summary
The aim of this study is to compare the identification of CS scar niche between 2D transvaginal ultrasonography alone and with the use of saline infusion as a contrast. Does it differ in the measurements and identification or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2021
CompletedStudy Start
First participant enrolled
June 20, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2022
CompletedJune 22, 2021
June 1, 2021
6 months
June 16, 2021
June 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
accurate evaluation of CS section niche
comparison of imaging CS niche by 2D transvaginal US and sonohysterography
6 months from the date of approval
Study Arms (1)
2D transvaginal ultrasonography
OTHERInterventions
saline infusion transvaginally followed by 2D transvaginal ultrasound imaging
Eligibility Criteria
You may qualify if:
- women with previous CS section scar seeking pregnancy or having gynecological complications
You may not qualify if:
- women having other gynecological pathology other than niche
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at diagnostic radiology department
Study Record Dates
First Submitted
June 16, 2021
First Posted
June 22, 2021
Study Start
June 20, 2021
Primary Completion
December 20, 2021
Study Completion
February 20, 2022
Last Updated
June 22, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share