Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001008415
Ethics application status
Approved
Date submitted
26/05/2025
Date registered
11/09/2025
Date last updated
11/09/2025
Date data sharing statement initially provided
11/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title

Effectiveness of hysteroscopic resection of a niche
VERSUS Expectant management in women with premenstrual spotting
postmenstrual spotting
Scientific title

Effectiveness of hysteroscopic resection of a niche
VERSUS Expectant management in women with premenstrual spotting , A randomized controlled trial. .
Secondary ID [1] 314709 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean section niche 337628 0
postmentrual spotting 338494 0
Condition category
Condition code
Reproductive Health and Childbirth 333955 333955 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General or regional (spinal) anesthesia depending on the extent of the
procedure and surgeon preference.
duration of the intervention : 30 -60 minutes .
surgeon : senior specialist of endoscopic surgery.
*Positioning:
Lithotomy position with appropriate padding to avoid nerve injury.
Bladder should be emptied before the procedure.
3. Surgical Equipment:
*Rigid hysteroscope (5–9 mm) with operative channel.
*30° lens for better visualization.
*Electrosurgical loop momopolar or bipolar resectoscope .
*Uterine distension medium (normal saline for bipolar or glycine for
monopolar energy).
*Cervical dilators, if necessary.
*Fluid management system to monitor inflow and outflow.Cervical Dilation (if required):
Gradual dilation up to size compatible with the resectoscope.
2. Diagnostic Hysteroscopy:
Initial inspection of uterine cavity to locate the cesarean scar defect,
usually found at the anterior lower uterine segment.
4. Identification of Niche:
Appears as a pouch or depression at the scar site, often with retained
blood or mucus.
5. Resection Steps: a. Resect the Inferior Edge:
Use a bipolar loop or scissors to excise the fibrotic and overhanging
inferior edge of the niche to improve drainage and eliminate the pocket.
*Remove any granulation tissue or polypoidal growth inside the niche.
*Avoid aggressive resection of the superior edge to minimize thinning
of the overlying myometrium.
c. Coagulation:
Apply light coagulation to bleeding points, avoiding excessive energy
near the uterine serosa.
6.Fluid Balance Monitoring:
Monitor input and output of distension fluid to avoid fluid overload
(especially with glycine).
strategies to assess the adherence to the intervention is accurate record of operative notes.
Intervention code [1] 331161 0
Treatment: Surgery
Comparator / control treatment
Control arm: Expectant management&Follow-up: 6 and 12 months
follow up the clinical improvement of the patient without any medical or surgical intervention.
Control group
Active

Outcomes
Primary outcome [1] 341606 0
Number of days of post menstrual spotting
Timepoint [1] 341606 0
6 months post treatment
Secondary outcome [1] 448056 0
Patient satisfaction.
Timepoint [1] 448056 0
6 months post treatment
Secondary outcome [2] 448057 0
quality of life
Timepoint [2] 448057 0
6 months post treatment

Eligibility
Key inclusion criteria
*Women aged 18–45 years.
*History of at least one cesarean delivery.
*Presence of a uterine niche on transvaginal ultrasound.
*Complaints of postmenstrual spotting lasting >2 days per cycle.
*Regular menstrual cycles
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Active pelvic infection
*known coagulation disorders.
*Intrauterine device in place.
*Other causes of abnormal uterine bleeding (e.g., fibroids, polyps

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analysis.
Continuous variables: Student’s t-test or Mann–Whitney U test.
Categorical variables: Chi-square or Fisher’s exact test.
Repeated measures: ANOVA or mixed-models analysis.
Based on previous studies, assuming a mean difference of 2 days in
postmenstrual spotting and a standard deviation of 2.5 days, with 80% power
and 5% alpha error, approximately 50 women per group are needed (allowing
10% loss to follow-up: total n = 110).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 27084 0
Egypt
State/province [1] 27084 0

Funding & Sponsors
Funding source category [1] 319261 0
Self funded/Unfunded
Name [1] 319261 0
none
Country [1] 319261 0
Primary sponsor type
Hospital
Name
Maternity and children hospital faculty of medicine Minia University
Address
Country
Egypt
Secondary sponsor category [1] 321537 0
None
Name [1] 321537 0
no secondary sponsor
Address [1] 321537 0
Country [1] 321537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317674 0
Institutional Review Board faculty of Medicine Minia University
Ethics committee address [1] 317674 0
Ethics committee country [1] 317674 0
Egypt
Date submitted for ethics approval [1] 317674 0
19/05/2025
Approval date [1] 317674 0
14/07/2025
Ethics approval number [1] 317674 0
MUFMIRB 1626/07/2025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141774 0
Prof Reham Elkhateeb
Address 141774 0
Minia University, Damaris, Second Al Minya, Minya Governorate 2431436, Egypt .
Country 141774 0
Egypt
Phone 141774 0
+201011966648
Fax 141774 0
Email 141774 0
[email protected]
Contact person for public queries
Name 141775 0
Reham Elkhateeb
Address 141775 0
Minia University, Damaris, Second Al Minya, Minya Governorate 2431436, Egypt .
Country 141775 0
Egypt
Phone 141775 0
+201011966648
Fax 141775 0
Email 141775 0
[email protected]
Contact person for scientific queries
Name 141776 0
Reham Elkhateeb
Address 141776 0
Minia University, Damaris, Second Al Minya, Minya Governorate 2431436, Egypt .
Country 141776 0
Egypt
Phone 141776 0
+201011966648
Fax 141776 0
Email 141776 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.