Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery

Cesarean Section Clinical Trial

Official title:

Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery and Assessment of Its Risk Factors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05900492
• Other study ID #: cesarean scar niche R.F
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Delivery by cesarean section.

2. More than 6 months after delivery.

3. Cesarean section by senior resident or assistant lecturer.

Exclusion Criteria:

1. Single layer technique in uterine closure.

2. Uterine anomaly.

Related Conditions & MeSH terms

• Cesarean Section
• Dehiscence

Intervention

Procedure:
• cesarean section
caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of cesarean scar niche among cesarean deliveries	number of cases develop cesarean scar niche after cesarean deliveries	6 months after delivery
Secondary	risk factors that affect the development of the niche.	age- BMI- post operative infection - PROM(preterm rupture of membrane)	within 1 month of delivery