An interventional study of transvaginal ultrasonography and monophasic combined oral contraceptive pill in Abnormal Uterine Bleeding, Cesarean Section Complications and Uterine Scar, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
The purpose of the study is to compare the clinical efficacy and niche morphological changes following treatment with combined oral contraceptive pills (OCPs) versus a levonorgestrel-releasing intrauterine system (LNG-IUS) in women with symptomatic uterine niche-related abnormal uterine bleeding (AUB).
After eligibility and consenting, participants were randomized in a 1:1 ratio using a computer-generated block randomization list (block size of six). Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes, which were opened after consent.
All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth. Residual myometrial thickness, niche depth, length, and width were assessed.
Both treatments were provided free of charge. Participants could switch to the alternative method upon study completion. Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label. Assessments were performed at baseline and at 1, 3, and 6 months. Participants recorded:
95 studies on the registry are indexed under Metrorrhagia; 24 are open to participants now.
This study's enrollment of 166 is above the median of 109 across 73 interventional studies indexed under Metrorrhagia.
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Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received a monophasic combined oral contraceptive pill containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles.
Diagnostic Test: transvaginal ultrasonography · Drug: monophasic combined oral contraceptive pill
Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months.
Diagnostic Test: transvaginal ultrasonography · Device: 52 mg levonorgestrel-releasing intrauterine system
At baseline and at 6 months after the start of treatment, transvaginal ultrasonography was performed to assess residual myometrial thickness, niche depth, length, and width.
Participants received a monophasic combined oral contraceptive pills containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles.
Also known as: Technospiron
Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months.
Also known as: Mirena
The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
Time frame: at baseline and at 6 months post randomization
The total number of postmenstrual and/or intermenstrual spotting days per cycle.
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
Time frame: at baseline and at 1, 3, and 6 months post randomization
Total bleeding duration per cycle
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls. It includes days of menstruation plus days of spotting
Time frame: at baseline and at 1, 3, and 6 months post randomization
Pelvic pain scores
Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain.
Time frame: at baseline and at 1, 3, and 6 months
dysmenorrhea scores
Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain.
Time frame: at baseline and at 1, 3, and 6 months post randomization
Sexual function
Assessed using the validated 6-item Female Sexual Function Index (FSFI-6). The FSFI-6 score is the sum of the participant ordinal responses to the six items; the score can range from 2 to 30. Female sexual dysfunction is diagnosed if the total score is ≤ 19 (Isidori et al., J Sex Med 2010)
Time frame: at baseline and at 1, 3, and 6 months post randomization
Treatment satisfaction
Participants recorded on a 5-point Likert scale (where 1 means very dissatisfied and 5 means very satisfied), then dichotomized for analysis as yes for "Satisfied/Very Satisfied" and no for other responses.
Time frame: at 1, 3, and 6 months post randomization
Anatomical Niche Changes
Assessed via transvaginal ultrasonography including residual myometrial thickness, niche depth, length, and width.
Time frame: at baseline and at 6 months post randomization
Adverse events
Participants reported this to the main investigator via follow up visits or telephone calls
Time frame: at 1, 3, and 6 months post randomization
Complications
Participants reported this to the main investigator via follow up visits or telephone calls
Time frame: At 1, 3, and 6 months post randomization
Reasons for discontinuation
Participants reported this to the main investigator via follow up visits or telephone calls
Time frame: At 1, 3, and 6 months post randomization
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Benha University