Abnormal Uterine Bleeding, Cesarean Section Complications, Uterine Scar
Conditions
Keywords
cesarean scar defect, Uterine niche, abnormal uterine bleeding, oral contraceptive pills, levonorgestrel intrauterine system, randomized controlled trial
Brief summary
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).
Detailed description
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. * OCP group: 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), taken for 21 days starting on day 2 of menstruation for six consecutive cycles. * LNG-IUS group: Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first three days of menstruation for 6 months. 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: * Number of days of postmenstrual/intermenstrual spotting * Total bleeding duration per cycle * Pelvic pain and dysmenorrhea scores (10-point visual analogue scale) * Sexual well-being (FSFI-6 score) * Treatment satisfaction (satisfied/very satisfied vs. other responses) * Adverse events, complications, and reasons for discontinuation (including LNG-IUS expulsion) At 6 months, transvaginal ultrasonography was repeated to assess residual myometrial thickness, niche depth, length, and width.
Interventions
DIAGNOSTIC_TESTtransvaginal ultrasonography
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.
DRUGmonophasic combined oral contraceptive pill
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.
DEVICE52 mg levonorgestrel-releasing intrauterine system
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* women with at least one previous cesarean section. * presenting with postmenstrual or intermenstrual bleeding for ≥3 consecutive cycles lasting ≥2 days, and a total bleeding duration \>7 days per cycle. * All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth.
Exclusion criteria
* pregnancy * malignancy * other identifiable causes of abnormal uterine bleeding * abnormal cervical cytology * cervicitis * pelvic inflammatory disease * endometrial polyps * uterine fibroids * contraindications to either combined oral contraceptive pill or levonorgestrel-releasing intrauterine system * desire for pregnancy * refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline. | at baseline and at 6 months post randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total number of postmenstrual and/or intermenstrual spotting days per cycle. | at baseline and at 1, 3, and 6 months post randomization | 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. |
| Total bleeding duration per cycle | at baseline and at 1, 3, and 6 months post randomization | 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 |
| Pelvic pain scores | at baseline and at 1, 3, and 6 months | Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain. |
| dysmenorrhea scores | at baseline and at 1, 3, and 6 months post randomization | Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain. |
| Sexual function | at baseline and at 1, 3, and 6 months post randomization | 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) |
| Treatment satisfaction | at 1, 3, and 6 months post randomization | 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. |
| Anatomical Niche Changes | at baseline and at 6 months post randomization | Assessed via transvaginal ultrasonography including residual myometrial thickness, niche depth, length, and width. |
| Adverse events | at 1, 3, and 6 months post randomization | Participants reported this to the main investigator via follow up visits or telephone calls |
| Complications | At 1, 3, and 6 months post randomization | Participants reported this to the main investigator via follow up visits or telephone calls |
| Reasons for discontinuation | At 1, 3, and 6 months post randomization | Participants reported this to the main investigator via follow up visits or telephone calls |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAHMED ALNEZAMY, MD
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
Outcome results
None listed