Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding

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).

Timeline

Start

2025-02-05

Primary completion

2025-05-01

Completion

2025-11-01

Publications

• 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.
• Background 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.
• 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.
• 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.
• 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.
• 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

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