Scar NicheNCT07114705
The Relationship Between the Number of Ceserean Sections and Scar Niche Development
An observational study of Scar Niche and Infertility, Post Menstrual Spotting, run by Sohag University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Scar Niche, Infertility, Post Menstrual Spotting
- What is being tested?
- Transvaginal ultrasound
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2025to 2 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- History of at least one previous cesarean section in non pregnant women.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scar Niche, Infertility, Post Menstrual Spotting
- Being tested
- Transvaginal ultrasound
- Keywords
- Scar niche
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDiagnostic test
This is the only method
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Women with 1 Previous Cesarean Section or more | Not described Receives: Diagnostic Test: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Name Presence of Cesarean Scar Niche
Detection of cesarean scar defect (niche) using transvaginal ultrasound.
Measured: At time of ultrasound evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Aug 2025 (estimated)
- Primary completion2 Aug 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar NicheStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Nasser Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114705
- Sponsor's protocol ID
- So-med-25-7-15MS
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I dont know
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Number of Ceserean Sections and Scar Niche Development :Cross Sectional Study
- ClinicalTrials.gov ID
- NCT07114705
- Acronym / sponsor ID
- So-med-25-7-15MS
- Conditions
- Scar Niche, Infertility, Post Menstrual Spotting
- Keywords
- Scar niche
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (estimated)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Women with 1 Previous Cesarean Section or more | – | Diagnostic Test: Transvaginal ultrasound |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- History of at least one previous cesarean section in non pregnant women.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasoundThis is the only method | Diagnostic test | Group 1: Women with 1 Previous Cesarean Section or more |
Primary outcome
Name Presence of Cesarean Scar Niche
Time frame: At time of ultrasound evaluation
Detection of cesarean scar defect (niche) using transvaginal ultrasound.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided. I dont know
Related trials for Scar Niche
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruitingObservational study
Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS
Scar Niche
Recruiting
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
Caesarean Scar Niche
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Scar Niche and Infertility, Post Menstrual Spotting, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Name Presence of Cesarean Scar Niche (time frame: At time of ultrasound evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.