At a glance
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Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for the Management of Niche-Related Abnormal Uterine Bleeding: A Prospective Open-Label Randomized Controlled Trial
In Brief
A clinical study evaluating transvaginal ultrasonography, monophasic combined oral contraceptive pill, and 1 other intervention for Abnormal Uterine Bleeding and 2 related conditions. Completed, enrolled 166 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
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.
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.