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

Benha University

Status: Completed

Conditions: Cesarean Section Complications; Uterine Scar; Abnormal Uterine Bleeding

Treatments: Diagnostic Test: transvaginal ultrasonography; Drug: monophasic combined oral contraceptive pill; Device: 52 mg levonorgestrel-releasing intrauterine system

Study type: Interventional

Funder types: Other

Identifiers

NCT07229209

RC10-2-2025

Details and patient eligibility

About

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).

Full 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 (5-point Likert scale)
• 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

combined oral contraceptive pill group

Active Comparator group

Description:

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.

Treatment:

Drug: monophasic combined oral contraceptive pill

Diagnostic Test: transvaginal ultrasonography

levonorgestrel-releasing intrauterine system group

Active Comparator group

Description:

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.

Treatment:

Device: 52 mg levonorgestrel-releasing intrauterine system

Diagnostic Test: transvaginal ultrasonography