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NCT Number: NCT07114705

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transvaginal ultrasound

Diagnostic Test

This is the only method

Primary outcomes

  1. Name Presence of Cesarean Scar Niche

    Time frame: At time of ultrasound evaluation

    Detection of cesarean scar defect (niche) using transvaginal ultrasound.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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