2D and 3D Ultrasound Assessment of Cesarean Section Scars
1 other identifier
observational
300
1 country
1
Brief Summary
Prospective observational study conducted on women with previous 1 or 2 CS candidate for elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
1 active site
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
April 8, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedApril 14, 2017
April 1, 2017
1 year
April 8, 2017
April 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Scar dehiscence
as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
At time of surgery
Study Arms (2)
dehiscencd scar
women who are discovered with scar dehiscence during cesarean section
Intact scar
women with intact scar detected during cesarean section
Interventions
During Cesarean delivery the lower uterine segment (LUS) was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
Eligibility Criteria
women with prior 1 or 2 cesarean sections candidate for elective cesarean sewction
You may qualify if:
- weeks of gestational age
- singleton pregnancy,
- cephalic presentation,
- not in labor
- intact membranes
- with history of one or two previous CS
You may not qualify if:
- disorders of amniotic fluid,
- placenta previa
- history of other uterine surgery, e.g, myomectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, Cairo Governorate, 12151, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged, MD
Kasr Alainy medical school
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 8, 2017
First Posted
April 13, 2017
Study Start
May 1, 2017
Primary Completion
May 1, 2018
Study Completion
July 1, 2018
Last Updated
April 14, 2017
Record last verified: 2017-04