Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery

Active, not recruiting

• Conditions: Dehiscence; Cesarean Section
• Interventions: Procedure: cesarean section

• Registration Number: NCT05900492
• Lead Sponsor: Beni-Suef University

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-04
• Last Update Submitted: 2023-06-11
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
previous 1 cesarean section	cesarean section	patient who had her first Cesarean section
previous 2 cesarean sections	cesarean section	patient who had her second Cesarean sections
previous 3 or more cesarean sections	cesarean section	patient who had 3 or more Cesarean sections

Primary Outcome Measures

Name	Time	Method
the incidence of cesarean scar niche among cesarean deliveries	6 months after delivery	number of cases develop cesarean scar niche after cesarean deliveries

Secondary Outcome Measures

Name	Time	Method
risk factors that affect the development of the niche.	within 1 month of delivery	age- BMI- post operative infection - PROM(preterm rupture of membrane)

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt