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

Benha University80 enrolled

Overview

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. * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abnormal Uterine Bleeding Cesarean Section Complications Uterine Scar

Interventions

transvaginal ultrasonographyDIAGNOSTIC_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.

monophasic combined oral contraceptive pillDRUG

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.

52 mg levonorgestrel-releasing intrauterine systemDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, Egypt