Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cesarean Section; Dehiscence
• Intervention / Treatment: Procedure: cesarean section

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Beni-Suef University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
previous 1 cesarean section; patient who had her first Cesarean section	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
previous 2 cesarean sections; patient who had her second Cesarean sections	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
previous 3 or more cesarean sections; patient who had 3 or more Cesarean sections	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of cesarean scar niche among cesarean deliveries	number of cases develop cesarean scar niche after cesarean deliveries	6 months after delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: sara M salem, MD, Faculty of Medicine Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: cesarean scar niche R.F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No