Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery and Assessment of Its Risk Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- the incidence of cesarean scar niche among cesarean deliveries
Study Overview
Brief Summary
To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.
Detailed Description
It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital using Ultrasound:
Six months after the cesarean delivery, participants will be invited to the gynecologic outpatient clinic or department for ultrasound (US) examination to detect the presence of the niche.
Women without contraception will be examined during the follicular phase of the menstrual cycle to avoid an eventual early pregnancy. Otherwise, a random phase of the menstrual cycle will be accepted. Women who are pregnant at the time of US will be excluded. Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way, with trans-vaginal US performed first.
For the diagnosis of cesarean scar niche (defined as an anechoic defect in the anterior wall of the lower uterine segment, communicating with the endometrial cavity),we will use a predetermined definition of a defect at least 2.0 mm deep
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Delivery by cesarean section.
- •More than 6 months after delivery.
- •Cesarean section by senior resident or assistant lecturer.
Exclusion Criteria
- •Single layer technique in uterine closure.
- •Uterine anomaly.
Outcomes
Primary Outcomes
the incidence of cesarean scar niche among cesarean deliveries
Time Frame: 6 months after delivery
number of cases develop cesarean scar niche after cesarean deliveries
Secondary Outcomes
- risk factors that affect the development of the niche.(within 1 month of delivery)
Investigators
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University