Efficacy of levonorgestrel-releasing intrauterine system (LNG-IUS) in managing abnormal uterine bleeding: A prospective study at maternal hospital, GMC Jammu

Background: Abnormal uterine bleeding (AUB) is a common gynecological condition affecting women of reproductive age. This study aimed to evaluate the efficacy of the levonorgestrel -releasing intrauterine system (LNG -IUS) in managing AUB, focusing on bleeding p atterns, comorbidities, and ultrasound findings.

A prospective interventional study was conducted at Maternity Hospital, Government Medical College (GMC), Jammu, from January 2022 to January 2023. Eighty women aged 30 -45 years with AUB were enroll ed. LNG -IUS was inserted, and patients were followed up at 1, 4, and 12 months. Bleeding patterns, hemoglobin levels, and ultrasound findings were recorded.

Significant improvements were observed in bleeding patterns, with amenorrhea rates increas ing from 5.7% at 1 month to 73.5% at 12 months. Hemoglobin levels improved from a baseline mean of 6.8 g/dL to 9.8 g/dL. Comorbidities such as hypertension (18.8%) and diabetes (7.5%) were prevalent. Ultrasound findings revealed adenomyosis in 37.5% and fibroids in 18.6% of participants.

LNG-IUS is an effective, nonsurgical treatment for AUB, significantly reducing menstrual bleeding and improving hemoglobin levels. It is a viable option for women seeking fertility -sparing management of AUB.

Abnormal uterine bleeding (AUB), LNG-IUS, Adenomyosis, Uterine fibroids, Menorrhagia, Amenorrhea

Abnormal uterine bleeding (AUB) is a prevalent gynecological condition characterized by irregular menstrual bleeding in terms of frequen cy, duration, or volume. It affects 10 -30% of women of reproductive age and accounts for a significant proportion of gynecological consultations (Munro et al., 2011) [3]. AUB can result from various causes, including hormonal imbalances, uterine fibroids, adenomyosis, and systemic conditions such as thyroid disorders or coagulopathies. The levonorgestrel-releasing intrauterine system (LNG -IUS), commonly known as Mirena, has emerged as a highly effective treatment for AUB. It releases levonorgestrel locally, inducing endometrial suppression and reducing menstrual blood loss. Studies have demonstrated that LNG-IUS reduces blood loss by 86% within three months and up to 97% by 12 months (Fraser et al., 2020) [1]. Additionally, it offers contraceptive benefits and Preserves fertility, making it an attractive option for women seeking nonsurgical management of AUB. This study aimed to evaluate the efficacy of LNG -IUS in managing AUB, focusing on bleeding patterns, comorbidities, and ultrasound findings among women at Maternity Hospital, GMC Jammu, over a one-year period.

Study design and setting This prospective interventional study was conducted at Maternity Hospital, Government Medical College (GMC), Jammu, from January 2022 to January 2023. The study inc luded 80 women aged 30-45 years with AUB and a uterine size of less than 12 weeks. International Journal of Clinical Obstetrics and Gynaecologyhttps://www.gynaecologyjournal.com ~ 1323 ~ Inclusion criteria ● Women aged 30-45 years with heavy menstrual bleeding. ● Uterine size 3 cm). ● Active pelvic inflammatory disease or unexplained genital bleeding. ● Systemic diseases (e.g., liver, renal, or neurological disorders). ● Contraindications to LNG-IUS. ● Bleeding due to pregnancy (abortion etc) Procedure Participants underwent a thorough c linical evaluation, including history-taking, physical examination, and diagnostic tests such as transvaginal ultrasonography, Pap smear, and endometrial biopsy. LNG -IUS was inserted in the outpatient department using a no -touch technique. Patients were ad vised to maintain a menstrual calendar to track bleeding patterns and were followed up at 1, 4, and 12 months. Outcome measures ● Bleeding patterns assessed using the Pictorial Blood Loss Assessment Chart (PBAC). ● Hemoglobin levels at baseline and follow-up visits. ● Ultrasound findings, including fibroids, adenomyosis, and endometrial thickness. Statistical analysis Data were analyzed using SPSS version 25. Descriptive statistics were used to summarize demographic and clinical characteristics. Paired t -tests were used to compare hemoglobin levels before and after LNG-IUS insertion. Table 1: Profile of Comorbidities (n = 80) Comorbidities Number (n = 80) Percentage Diabetes 06 07.5% Hypertension 15 18.8% Thyroid 05 06.3% Malignancy — — Others 13 16.3%

From the table 1, the study results showed that the study included 80 women with a mean age of 38.5 years and out of 80 participants, 39 (48.8%) had at least one co -morbidity. Co - morbidities prevalent were hypertension (18.8%) and diabetes (7.5%) being the most common. Table 2: Profile of Bleeding Patterns (up to 1 year, n = 80) Bleeding Patterns 1 month (n = 80) 4 months (n = 80) 1 year (n = 80) Amenorrhea 5 (6.3%) 16 (20%) 50 (62.5%) Heavy bleeding — 2 (2.5%) 1 (1.3%) Moderate flow 9 (11.3%) 4 (5%) 3 (3.8%) Spotting 64 (80%) 55 (68.8%) 17 (21.3%) From the table2, the study results revealed the bleeding patterns in different categories with spotting as the commonest pattern 80% at 1 month 68% at 4 months to 21.3% at 12 months and amenorrhea as the most common attained at 12 months period from 6.3% at one month to 62.5% at 1 year showing significant improvements. Table 3: Bleeding Pattern in Adenomyosis (up to 1 year, n = 80) Bleeding Pattern 1 month (n = 40) 4 months (n = 40) 1 year (n = 40) Spotting 31 (77.5%) 31 (77.5%) 20 (50%) Moderate flow 7 (17.5%) 3 (7.5%) — Amenorrhea — 2 (5%) 20 (50%) Menorrhagia 2 (5%) 4 (10%) — From table 3, the results revealed that out 80 participants 40 were diagnosed with adenomyosis and out of thes e 40 participants the Spotting decreases significantly by the 1 -year from 77.5% to 50 % indicating better management of symptoms. Moderate flow (17.5% at 1 month and 7.5% at 4 month to 0 at 12 months) and menorrhagia (5 % at 1 month and 10% at 4 month to 0 at 12 months) are eliminated by the 1 -year reflecting improved outcomes. While as Amenorrhea increases significantly at the 1 -year mark from 0 at 1 month and 5% at 4 month to 50 % at 12 months showing a positive trend toward reduced bleeding. Table 4: Bleeding Pattern in Uterine Myomas (up to 1 year, n = 80) Bleeding Pattern 1 month (n = 15) 1 month (n = 15) 4 months (n = 15) 1 year (n = 15) Spotting 12 (76.9%) 12 (76.9%) 12 (76.9%) 3 (23%) — Moderate flow 3 (23%) 3 (23%) 1 (7.7%) 10 (69.2%) Amenorrhea — - 2 (15.4%) 1 (7.7%) Menorrhagia - - - From the table 4, the study results showed that out of 80 participants 15 were having myomas and out of 15, 76.9% International Journal of Clinical Obstetrics and Gynaecologyhttps://www.gynaecologyjournal.com ~ 1324 ~ represented with spotting at 1 month and 4 month that significantly reduced to 23% at 12 month while as the amenorrhea represented by none of the participant at 1 month attained 15.4% at 4 month then decreased to 7.7% at 12 month. Table 5: Hemoglobin-Levels Time period Mean hb level (g/dl) Improvement from baseline Baseline 6.8 — 1 Month 7.4 +0.6 4 Months 9.2 +2.4 12 Months 9.8 +3.0 From the table 5, the results revealed that the mean Hb level at the start of the study was 6.8 g/dL, indicating anemia in most participants. However at 1 Month Post -Insertion: Hb levels improved to 7.4 g/dL, sho wing a +0.6 g/dL increase, 4 Months Post-Insertion: Hb levels further improved to 9.2 g/dL, a +2.4 g/dL increase from baseline and at 12 Months Post-Insertion: Hb levels reached 9.8 g/dL, a +3.0 g/dL increase from baseline, indicating significant improveme nt in anemia. Overall Hemoglobin levels improved significantly from a baseline mean of 6.8 g/dL to 9.8 g/dL at 12 months (p<0.001). Table 6: Ultrasound Findings (n = 80) Ultrasound Findings Number (n = 80) Percentage Fibroid (total) 15 18.6% Subserous fibroid 5 6.3% Intramural fibroid 6 7.5% Anterior wall fibroid 1 1.3% Multiple small fibroids 2 2.5% Submucous fibroid 1 1.3% Adenomyosis (Total) 30 37.5% Adenomyoma 15 18.8% From table 6, the study results showed that out of 80 participants, Aden omyosis was the commonest USG finding affecting 30 (37.5%) study participants while as fibroids and myoma being the same in number each affecting 15(18.8%) participants. However among fibroids, the intra -mural fibroid represented the common finding affecting 6 (7.5%) participants.

In the present study, the majority of the women (48.8%) had at least one comorbidity, with hypertension (18.8%) and diabetes (7.5%) being the most common. This finding is consistent with the study by Gupta et al. (2019) [2], where systemic conditions such as hypertension and diabetes were frequently associated with abnormal uterine bleeding (AUB), exacerbating menstrual irregularities and contributing to anemia.10 The mean age of the participants was 38.5 years, which a ligns with the study by Raghuwanshi et al , where the majority of patients were in the age group of 31 -40 years, further supporting the demographic profile of women presenting with AUB [11]. The study revealed significant improvements in bleeding patterns o ver the 12 -month follow -up period. Spotting, which was the most common bleeding pattern at baseline (80%), decreased to 21.3% by the 12th month. Conversely, amenorrhea, observed in only 6.3% of participants at 1 month, increased significantly to 62.5% by t he end of the study. This trend aligns with the findings of Kriplani et al, who reported that LNG -IUS effectively reduces menstrual bleeding and promotes amenorrhea in a substantial proportion of users. 15 The reduction in heavy bleeding and moderate flow further underscores the efficacy of LNG -IUS in managing AUB, as demonstrated in the study by Andersson a nd Rybo, where LNG- IUS reduced menstrual blood loss by up to 97% after 12 months of use [9]. In the subgroup analysis of participants with adenomyosis (n=40), similar improvements were observed. Spotting decreased from 77.5% at baseline to 50% at 12 months, while amenorrhea increased from 0% at baseline to 50% at 12 months. These findings are consistent with the study by Desai et al , where LNG -IUS signifi cantly reduced bleeding and improved quality of life in women with adenomyosis.14 The elimination of moderate flow and menorrhagia by the 12th month further highlights the therapeutic benefits of LNG -IUS in this population, as reported by Hidalgo et al , wh o noted a strong suppression of endometrial activity with LNG -IUS use [3]. Among participants with uterine myomas (n=15), spotting decreased from 76.9% at baseline to 23% at 12 months, while amenorrhea increased to 15.4% by the 4th month but decreased slightly to 7.7% by the 12th month. Although the sample size for this subgroup was small, the results suggest that LNG -IUS can also be effective in managing bleeding patterns in women with uterine myomas, albeit to a lesser extent compared to those with adenomyosis. This is supported by the study by Singh et al , where LNG-IUS was found to be effective in reducing menstrual blood loss in women with fibroids [13]. The study also demonstrated significant improvements in hemoglobin levels, with mean Hb increasing f rom 6.8 g/dL at baseline to 9.8 g/dL at 12 months. This improvement is clinically significant, as it indicates a reduction in anemia, which is a common complication of AUB. The rise in Hb levels is consistent with the reduction in menstrual blood loss observed in this study and is comparable to findings from Kriplani et al, who reported a mean Hb increase from 7.2 g/dL to 10.1 g/dL after 6 months of LNG-IUS use [15]. Ultrasound findings revealed that adenomyosis was the most common pathology (37.5%), follow ed by fibroids (18.8%). These findings are consistent with the PALM -COEIN classification, which identifies adenomyosis and fibroids as common structural causes of AUB. The high prevalence of adenomyosis in this study underscores the need for effective non-surgical treatment options, such as LNG -IUS, in this population, as highlighted by Dhakane et al. (2021) [11]. Overall, the study findings are consistent with previous research that has demonstrated the efficacy of LNG -IUS in reducing International Journal of Clinical Obstetrics and Gynaecology https://www.gynaecologyjournal.com ~ 1325 ~ menstrual blood loss, improving hemoglobin levels, and promoting amenorrhea in women with AUB. The high patient satisfaction rates and low expulsion rates observed in this study further support the use of LNG -IUS as a first -line treatment for AUB, particularly in women who wis h to preserve their fertility or avoid surgical interventions, as reported by Desai et al.

The levonorgestrel -releasing intrauterine system (LNG -IUS) is an effective and well -tolerated treatment option for women with abnormal uterine bleeding ( AUB). The study demonstrated significant improvements in bleeding patterns, with a notable increase in amenorrhea and a reduction in spotting, heavy bleeding, and moderate flow over a 12 -month period. These changes were accompanied by a significant improve ment in hemoglobin levels, indicating a reduction in anemia, which is a common complication of AUB. The study also highlighted the effectiveness of LNG -IUS in managing AUB associated with adenomyosis and uterine myomas, although the benefits were more pronounced in women with adenomyosis. The high prevalence of adenomyosis in this study underscores the importance of considering LNG -IUS as a first-line treatment for this condition. In conclusion, LNG -IUS provides a safe, effective, and reversible alternative to surgical interventions for the management of AUB. It not only reduces menstrual blood loss but also improves quality of life and patient satisfaction. The device is particularly beneficial for women who wish to preserve their fertility or avoid hystere ctomy. Given its favorable safety profile and high efficacy, LNG -IUS should be considered as a primary treatment option for women with AUB, especially those with comorbid conditions such as hypertension and diabetes. Funding No funding sources. Conflict of Interest None declared.

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