The Relationship Between the Number of Ceserean Sections and Scar Niche Development

The Relationship Between the Number of Ceserean Sections and Scar Niche Development :Cross Sectional Study

Aim of the work This study aims to investigate the relationship between the number of previous cesarean sections (CS) and the incidence of a cesarean scar niche.

Study Overview

• Status: Not yet recruiting
• Conditions: Scar Niche; Infertility, Post Menstrual Spotting
• Intervention / Treatment: Diagnostic test: Transvaginal ultrasound

Detailed Description

Cesarean section (CS) is a common surgical procedure globally, with increasing rates over the past few decades (WHO, 2021). This rise has led to concerns about its long-term complications, including the formation of Cesarean scar niches, also known as isthmoceles (the most common), Cesarean scar defect, Cesarean scar pouch, Cesarean scar diverticulum, Uterine niche and Myometrial defect at cesarean scar. These niches are characterized by discontinuation of the myometrium at the site of the previous CS, often presenting as a hypoechoic area within the lower uterine segment (Elkashef et al., 2023).

The prevalence of cesarean scar niches varies widely, ranging from 6.9% to 69%, depending on the diagnostic method used and the population studied (Elkashef et al., 2023; Alassi et al., 2022). In Egypt, the incidence of CS has increased significantly, contributing to a higher risk of niche formation. Recent studies have highlighted a significant relationship between the number of cesarean deliveries and the risk of developing a scar niche, with multiple CS being a major risk factor (Elkashef et al., 2023).

For instance, multiple cesarean sections may interfere with tissue perfusion and are associated with increased width and depth of the scar defects (Tilahun et al., 2023).

Cesarean scar niches are associated with various clinical symptoms, including abnormal uterine bleeding, chronic pelvic pain, dysmenorrhea, and subfertility, significantly impacting a woman's quality of life (Alassi et al., 2022). The formation of these niches can also lead to complications such as ectopic pregnancies and placenta accreta spectrum disorders (Jauniaux, et al., 2022). Understanding these risks and factors is crucial for developing preventive strategies and managing potential complications.

• Study Type: Observational
• Enrollment (Estimated): 82

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes women of reproductive age who have undergone one or more cesarean section deliveries. Participants will be recruited from obstetrics and gynecology outpatient clinics. The study focuses on evaluating the presence and severity of scar niche in relation to the number of cesarean sections.

Description

Inclusion Criteria:

• History of at least one previous cesarean section in non pregnant women.

Exclusion Criteria:

• Women with known uterine anomalies (e.g., bicornuate uterus, uterine septum). Previous uterine surgery other than CS (e.g., myomectomy). History of uterine rupture in previous pregnancies.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Women with 1 Previous Cesarean Section or more	Diagnostic test: Transvaginal ultrasound; This is the only method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Name Presence of Cesarean Scar Niche	Detection of cesarean scar defect (niche) using transvaginal ultrasound.	At time of ultrasound evaluation

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): August 2, 2025
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): September 2, 2026

Study Registration Dates

• First Submitted: August 3, 2025
• First Submitted That Met QC Criteria: August 3, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Scar niche
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage; Infertility; Metrorrhagia
• Other Study ID Numbers: So-med-25-7-15MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I dont know

Drug and device information, study documents

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