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Not yet recruiting NCT07114705

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

Observational Scar Niche Infertility, Post Menstrual Spotting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transvaginal ultrasound.
Who it may be relevant to
Registry conditions: Scar Niche, Infertility, Post Menstrual Spotting. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Diagnostic test Transvaginal ultrasound
    This is the only method

Primary outcome measures

  • Name Presence of Cesarean Scar Niche [Time frame: At time of ultrasound evaluation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07114705 · So-med-25-7-15MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗