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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined oral contraceptive pill group | Active Comparator | 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. |
|
| levonorgestrel-releasing intrauterine system group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transvaginal ultrasonography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and at 6 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and at 1, 3, and 6 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED ALNEZAMY, MD | Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha Univesity Hospital | Banhā | Qalyubia Governorate | 13512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21858885 | Background | Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077. | |
| 27393285 |
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Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label.
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| monophasic combined oral contraceptive pill | Drug | 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. |
|
|
| 52 mg levonorgestrel-releasing intrauterine system | Device | 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. |
|
|
| 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 | 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. | 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. | 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) | 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. | at 1, 3, and 6 months post randomization |
| Anatomical Niche Changes | Assessed via transvaginal ultrasonography including residual myometrial thickness, niche depth, length, and width. | at baseline and at 6 months post randomization |
| Adverse events | Participants reported this to the main investigator via follow up visits or telephone calls | at 1, 3, and 6 months post randomization |
| Complications | Participants reported this to the main investigator via follow up visits or telephone calls | 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 | At 1, 3, and 6 months post randomization |
| Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5. |
| 21343754 | Background | Vikhareva Osser O, Valentin L. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Mar;117(3):525-532. doi: 10.1097/AOG.0b013e318209abf0. |
| 32228874 | Background | Donnez O. Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased. Fertil Steril. 2020 Apr;113(4):704-716. doi: 10.1016/j.fertnstert.2020.01.037. |
| 29536581 | Background | Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049. |
| 19968774 | Background | Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1. |
| 39680143 | Result | Stavridis K, Balafoutas D, Vlahos N, Joukhadar R. Current surgical treatment of uterine isthmocele: an update of existing literature. Arch Gynecol Obstet. 2025 Jan;311(1):13-24. doi: 10.1007/s00404-024-07880-w. Epub 2024 Dec 16. |
| 37506497 | Result | Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15. |
| 35985862 | Result | Murji A, Sanders AP, Monteiro I, Haiderbhai S, Matelski J, Walsh C, Abbott JA, Munro MG, Maheux-Lacroix S; International Federation of Gynecology and Obstetrics (FIGO) Committee on Menstrual Disorders and Related Health Impacts. Cesarean scar defects and abnormal uterine bleeding: a systematic review and meta-analysis. Fertil Steril. 2022 Oct;118(4):758-766. doi: 10.1016/j.fertnstert.2022.06.031. Epub 2022 Aug 17. |
| 36720538 | Result | You SH. The symptomatic cesarean scar defect with oral contraceptive pills treatment following evacuation of a cesarean scar pregnancy. Taiwan J Obstet Gynecol. 2023 Jan;62(1):181-183. doi: 10.1016/j.tjog.2022.04.012. No abstract available. |
| 31381242 | Result | Chen YY, Tsai CC, Lan KC, Ou YC. Preliminary report on the use of a levonorgestrel intrauterine system for the treatment of intermenstrual bleeding due to previous cesarean delivery scar defect. J Obstet Gynaecol Res. 2019 Oct;45(10):2015-2020. doi: 10.1111/jog.14060. Epub 2019 Aug 5. |
| 36935068 | Result | Zhang J, Zhu C, Yan L, Wang Y, Zhu Q, He C, He X, Ji S, Tian Y, Xie L, Liang Y, Xia W, Mol BW, Huirne JAF. Comparing levonorgestrel intrauterine system with hysteroscopic niche resection in women with postmenstrual spotting related to a niche in the uterine cesarean scar: a randomized, open-label, controlled trial. Am J Obstet Gynecol. 2023 Jun;228(6):712.e1-712.e16. doi: 10.1016/j.ajog.2023.03.020. Epub 2023 Mar 17. |
| 27473332 | Result | Zhang X, Yang M, Wang Q, Chen J, Ding J, Hua K. Prospective evaluation of five methods used to treat cesarean scar defects. Int J Gynaecol Obstet. 2016 Sep;134(3):336-9. doi: 10.1016/j.ijgo.2016.04.011. Epub 2016 Jun 30. |
| 37417378 | Result | Zheng F, Chen S, Yang W, Li J, Huang Q, Qin H, Wei J, Lin J. Comparison of the efficacy of oral contraceptives and levonorgestrel intrauterine system in intermenstrual bleeding caused by uterine niche. Ginekol Pol. 2024;95(8):621-626. doi: 10.5603/GP.a2023.0067. Epub 2023 Jul 7. |
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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