Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for the Management of Niche-Related Abnormal Uterine Bleeding: A Prospective Open-Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
combined oral contraceptive pill 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), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles.
干预措施: transvaginal ultrasonography (Diagnostic Test)
combined oral contraceptive pill 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), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles.
干预措施: monophasic combined oral contraceptive pill (Drug)
levonorgestrel-releasing intrauterine system group
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.
干预措施: transvaginal ultrasonography (Diagnostic Test)
levonorgestrel-releasing intrauterine system group
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.
干预措施: 52 mg levonorgestrel-releasing intrauterine system (Device)
结局指标
主要结局
The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.
时间窗: 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.
次要结局
- Pelvic pain scores(at baseline and at 1, 3, and 6 months)
- The total number of postmenstrual and/or intermenstrual spotting days per cycle.(at baseline and at 1, 3, and 6 months post randomization)
- Total bleeding duration per cycle(at baseline and at 1, 3, and 6 months post randomization)
- dysmenorrhea scores(at baseline and at 1, 3, and 6 months post randomization)
- Sexual function(at baseline and at 1, 3, and 6 months post randomization)
- Treatment satisfaction(at 1, 3, and 6 months post randomization)
- Anatomical Niche Changes(at baseline and at 6 months post randomization)
- Adverse events(at 1, 3, and 6 months post randomization)
- Complications(At 1, 3, and 6 months post randomization)
- Reasons for discontinuation(At 1, 3, and 6 months post randomization)
研究者
Ahmed Abdel Latif Ahmed Alnezamy
Lecturer of Obstetrics and Gynecology, Faculty of Medicine
Benha University