Cesarean Scar NicheNCT06466343
Immunohistopathologic Findings of Cesarean Scar Niche
A study testing hysteroscopic resection of lower edge of cesarean scar niche in people with Cesarean Scar Niche, run by Sohag University at 1 site in Egypt.
Trial summary
Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made. Still, a niche has generally been defined as the myometrium's depression of at least 2 mm (Lumbanraja et al., 2024). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Scar Niche
- What is being tested?
- hysteroscopic resection of lower edge of cesarean scar niche
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Any Women with history of previous CS once or more with period more than one year from the last CS and had CS scar defect diagnosed by TVUS.
Who cannot join
- All women diagnosed with pelvic inflammatory disease, suspected with gynecological malignancy, postmenopausal women, women with heart disease, liver disease, renal impairment or bleeding tendency will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag
mohamed Ab Galal, lecturer, 01095926603, mohamed_hussien1@med.sohag.edu.eg
About this study
Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made. Still, a niche has generally been defined as the myometrium's depression of at least 2 mm (Lumbanraja et al., 2024).
The literature is lacking in information about the accurate histopathologic characteristics of cesarean scar niche ridges that have been removed by hysteroscopy, as well as what critical findings to highlight and what gynaecologists can anticipate from pathology reports of cesarean scar niche specimens (AbdullGaffar \& Almulla ,2022).
In this study the aim of the work is to study the histopathologic findings in cesarean scar niche specimens repaired by hysteroscopy in our institution, identify the causes of local thinning of the uterine scar after c-section to direct gynecologists regarding the efficacy of their hysteroscopic corrective repair of cesarean scar niche concerning the amelioration of symptoms, restoration of fertility, and patient follow-up.
Read the detailed description
Subjects \& Methods Study will be conducted on non-pregnant women with symptomatic uterine scar niche after lower segment CS at Obstetrics and Gynecology department at Sohag University Hospitals.
Patient recruitment:
All eligible patients attending at the Obstetrics and Gynecology outpatient clinic at the department will be approached by the attending physician A through explanation about the nature of the study to each patient. All patients agreeing to participate in the study will be asked to sign the informed written consent before enrollment in the study.
Ultrasound examination:
Uterine scar niche will be diagnosed by transvaginal Logic P7, GE US (frequency 50/60Hz) postmenstrual. In longitudinal plane of the uterus at anterior wall at site of CS, the depth, width, and residual myometrial thickness will be measured. All measures will be done by single operator.
Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made.The myometrium's depression of at least 2 mm.
Operative procedure:
For every patient, related clinical data will be gathered, age, parity, clinical presentation, number of previous CSs, history of secondary infertility, history of previous niche repair surgeries, and follow-up data will be included in this.
Operative hysteroscopy will be used for surgical treatment in the cases.
Histopathological examination:
The hematoxylin and eosin (H\&E) slides will be inspected to identify any changes related to the mucosa as well as the types of lining mucosa of the resected edges, the types of stroma and stroma-associated changes, the presence of myometrial tissue, and scarring. Slides will be also screened for inflammatory, hemorrhagic, degenerative changes, foreign body giant cell reaction and Masson trichrome stain: for staining of fibrosis (Higuchi et al., 2022).
Immunohistochemistry:
Using a sliding microtome, all paraffin-embedded blocks will be cut into 4-µm-thick sections. The parts will be floated in a water bath at 42°C before being put on slides. The antigens will be recovered in an antigen retrieval reagent following deparaffinization, CD3: a marker for T lymphocyte, CD20: a marker for B lymphocytes and CD34: a marker for angiogenesis.
Follow up:
Patients will be asked to come after 3 months for asking about improvement of symptoms, quality of life, transvaginal US evaluation will be done, and a questionnaire will be filled out (Herdman et al.,2003)
Statistical analysis:
The collected data was organized, tabulated, and statistically analyzed using Statistical Package for Social Science (SPSS) version 16 (SPSS Inc, USA). For quantitative data, mean and standard deviation (SD) will be calculated and for comparison between two means, the students (t) test will be used. For qualitative data, the frequency and percent distribution will be calculated and for comparison between groups, chi square (X2) will be used. For interpretation of results p value will be significant if less than 0.05.
- Conditions
- Cesarean Scar Niche
- Being tested
- hysteroscopic resection of lower edge of cesarean scar niche
- Keywords
- cesarean scar, Niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopic resection of lower edge of cesarean scar nicheProcedure or surgery
Operative hysteroscopy will be used for surgical treatment in the cases. Hysteroscopic management of niche will be done according to the following steps: Operative procedure will be done postmenstrual, cervical preparation will be done by giving the patients misoprostol (misotac®) 400mcg two hours preoperative. Surgically, operative resectoscope (KARL STORZ, Germany,27 Fr gauge) will be inserted into the uterine cavity after cervical dilatation by Hegar uterine dilator up to 8. Distilled water will be used as distension media. Using a resectoscope, the lower edge of the niche will be trimmed, the base will be coagulated by using monopolar cutting current at 30-50 MHz.
The resected parts will be submitted together as one sampled specimen in one container of formaldehyde 30% (dissolved 800 ml water and 200 ml formaldehyde)
| Study group | Role | What they receive |
|---|---|---|
| symptomatic non pregnant women | Other | Operative hysteroscopy will be used for surgical treatment in the cases. Hysteroscopic management of niche will be done according to the following steps: Operative procedure will be done postmenstrual, cervical preparation will be done by giving the patients misoprostol (misotac®) 400mcg two hours preoperative. Surgically, operative resectoscope (KARL STORZ, Germany,27 Fr gauge) will be inserted into the uterine cavity after cervical dilatation by Hegar uterine dilator up to 8. Distilled water will be used as distension media. Using a resectoscope, the lower edge of the niche will be trimmed, the base will be coagulated by using monopolar cutting current at 30-50 MHz. Receives: Procedure: hysteroscopic resection of lower edge of cesarean scar niche |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence and type of different pathological variations within examined CS niche specimens.
measure the incidence and type of different pathological variations within examined CS niche specimens.
Measured: three weeks
Secondary outcomes (1)
correlation of predominant pathological variation with symptoms of patient and radiological findings.
estimate correlation of predominant pathological variation with symptoms of patient and radiological findings.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study will be conducted on non-pregnant women with symptomatic uterine scar niche after lower segment CS at Obstetrics and Gynecology department at Sohag University Hospitals.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelnasser Galal, Sohag University
- Investigators
- mohamed Ab Galal, A.lecturer, Principal investigator, sohag faculty of medicine sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466343
- Sponsor's protocol ID
- Soh-Med-24-05-06MD
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistopathologic Findings of Cesarean Scar Niche
- ClinicalTrials.gov ID
- NCT06466343
- Acronym / sponsor ID
- Soh-Med-24-05-06MD
- Conditions
- Cesarean Scar Niche
- Keywords
- cesarean scar, Niche
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Jun 2024 (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.
Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made. Still, a niche has generally been defined as the myometrium's depression of at least 2 mm (Lumbanraja et al., 2024).
The literature is lacking in information about the accurate histopathologic characteristics of cesarean scar niche ridges that have been removed by hysteroscopy, as well as what critical findings to highlight and what gynaecologists can anticipate from pathology reports of cesarean scar niche specimens (AbdullGaffar \& Almulla ,2022).
In this study the aim of the work is to study the histopathologic findings in cesarean scar niche specimens repaired by hysteroscopy in our institution, identify the causes of local thinning of the uterine scar after c-section to direct gynecologists regarding the efficacy of their hysteroscopic corrective repair of cesarean scar niche concerning the amelioration of symptoms, restoration of fertility, and patient follow-up.
Detailed description
Subjects \& Methods Study will be conducted on non-pregnant women with symptomatic uterine scar niche after lower segment CS at Obstetrics and Gynecology department at Sohag University Hospitals.
Patient recruitment:
All eligible patients attending at the Obstetrics and Gynecology outpatient clinic at the department will be approached by the attending physician A through explanation about the nature of the study to each patient. All patients agreeing to participate in the study will be asked to sign the informed written consent before enrollment in the study.
Ultrasound examination:
Uterine scar niche will be diagnosed by transvaginal Logic P7, GE US (frequency 50/60Hz) postmenstrual. In longitudinal plane of the uterus at anterior wall at site of CS, the depth, width, and residual myometrial thickness will be measured. All measures will be done by single operator.
Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made.The myometrium's depression of at least 2 mm.
Operative procedure:
For every patient, related clinical data will be gathered, age, parity, clinical presentation, number of previous CSs, history of secondary infertility, history of previous niche repair surgeries, and follow-up data will be included in this.
Operative hysteroscopy will be used for surgical treatment in the cases.
Histopathological examination:
The hematoxylin and eosin (H\&E) slides will be inspected to identify any changes related to the mucosa as well as the types of lining mucosa of the resected edges, the types of stroma and stroma-associated changes, the presence of myometrial tissue, and scarring. Slides will be also screened for inflammatory, hemorrhagic, degenerative changes, foreign body giant cell reaction and Masson trichrome stain: for staining of fibrosis (Higuchi et al., 2022).
Immunohistochemistry:
Using a sliding microtome, all paraffin-embedded blocks will be cut into 4-µm-thick sections. The parts will be floated in a water bath at 42°C before being put on slides. The antigens will be recovered in an antigen retrieval reagent following deparaffinization, CD3: a marker for T lymphocyte, CD20: a marker for B lymphocytes and CD34: a marker for angiogenesis.
Follow up:
Patients will be asked to come after 3 months for asking about improvement of symptoms, quality of life, transvaginal US evaluation will be done, and a questionnaire will be filled out (Herdman et al.,2003)
Statistical analysis:
The collected data was organized, tabulated, and statistically analyzed using Statistical Package for Social Science (SPSS) version 16 (SPSS Inc, USA). For quantitative data, mean and standard deviation (SD) will be calculated and for comparison between two means, the students (t) test will be used. For qualitative data, the frequency and percent distribution will be calculated and for comparison between groups, chi square (X2) will be used. For interpretation of results p value will be significant if less than 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study will be conducted on non-pregnant women with symptomatic uterine scar niche after lower segment CS at Obstetrics and Gynecology department at Sohag University Hospitals.
| Arm | Type | Receives |
|---|---|---|
| symptomatic non pregnant women | Other | Procedure: hysteroscopic resection of lower edge of cesarean scar nicheOperative hysteroscopy will be used for surgical treatment in the cases. Hysteroscopic management of niche will be done according to the following steps: Operative procedure will be done postmenstrual, cervical preparation will be done by giving the patients misoprostol (misotac®) 400mcg two hours preoperative. Surgically, operative resectoscope (KARL STORZ, Germany,27 Fr gauge) will be inserted into the uterine cavity after cervical dilatation by Hegar uterine dilator up to 8. Distilled water will be used as distension media. Using a resectoscope, the lower edge of the niche will be trimmed, the base will be coagulated by using monopolar cutting current at 30-50 MHz. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any Women with history of previous CS once or more with period more than one year from the last CS and had CS scar defect diagnosed by TVUS.
Key exclusion criteria (1 listed)
- All women diagnosed with pelvic inflammatory disease, suspected with gynecological malignancy, postmenopausal women, women with heart disease, liver disease, renal impairment or bleeding tendency will be excluded from the study.
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 |
|---|---|---|
| hysteroscopic resection of lower edge of cesarean scar nicheOperative hysteroscopy will be used for surgical treatment in the cases. Hysteroscopic management of niche will be done according to the following steps: Operative procedure will be done postmenstrual, cervical preparation will be done by giving the patients misoprostol (misotac®) 400mcg two hours preoperative. Surgically, operative resectoscope (KARL STORZ, Germany,27 Fr gauge) will be inserted into the uterine cavity after cervical dilatation by Hegar uterine dilator up to 8. Distilled water will be used as distension media. Using a resectoscope, the lower edge of the niche will be trimmed, the base will be coagulated by using monopolar cutting current at 30-50 MHz. The resected parts will be submitted together as one sampled specimen in one container of formaldehyde 30% (dissolved 800 ml water and 200 ml formaldehyde) | Procedure or surgery | symptomatic non pregnant women |
Primary outcome
the incidence and type of different pathological variations within examined CS niche specimens.
Time frame: three weeks
measure the incidence and type of different pathological variations within examined CS niche specimens.
1 secondary outcome
correlation of predominant pathological variation with symptoms of patient and radiological findings.
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Cesarean Scar Niche
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Effect of Methotrexate on Blood Loss During Laparoscopic Management of CS Scar Pregnancy
Cesarean Scar Pregnancy
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Impact of a Bladder Flap on Cesarean Scar Niche Development
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Platelet Rich Plasma for Uterine Scar
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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. This study is not recruiting at the moment.
mohamed Ab Galal, A.lecturer principal investigator
sohag faculty of medicine sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscopic resection of lower edge of cesarean scar niche in people with Cesarean Scar Niche, run by Sohag University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed Ab Galal, A.Lecturer (01095926603, mohamed_hussien1@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence and type of different pathological variations within examined CS niche specimens. (time frame: three weeks). 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 20 Jun 2024.