Effectiveness and Safety of Levonorgestrel Intrauterine Device in Abnormal Uterine Bleeding, Adenomyosis and Perimenopausal Bleeding Patients

The levonorgestrel-releasing Intrauterine Device (IUD)is used in the treatment of AUB and as LARC (Long-Acting Reversible Contraceptive). It is an Intrauterine device that contains 52 mg of levonorgestrel (progesterone), released at a range of 20 mcg/day¹ and after five years it is decreased to half of its original value. IUD is removed by the end of the fifth year and can be replaced with a new one if necessary. The intrauterine device is inserted into the endometrial cavity of the patient. The horizontal arms of the device are folded and will be placed in the applicator tube. It is gently implanted in the uterus after the tube is introduced into the cervical canal. strings will be trimmed so that they don’t protrude too far into the vagina and the length of the string is recorded.

Cramping, dizziness, fainting, or a slower-than-normal heart rate may occur at the time of insertion.^2,3 This device is inserted in conditions like endometriosis, adenomyosis, and heavy menstrual bleeding. This device is contraindicated for conditions like uterine abnormality, pelvic inflammatory disease, abortion, postpartum endometritis, and acute cervicitis. The common side effects of this device include amenorrhea, bleeding or spotting between periods, heavy bleeding during the first few weeks after device insertion, abdominal and pelvic pain, headache, back pain, dizziness, nausea, tenderness of the breast and weight gain.⁴ AUB is described as irregularities in the menstrual cycle involving frequency, regularity, duration and volume of flow outside the pregnancy. IUD is used in types of AUB like AUB-Endometrial Hyperplasia (AUB-E), AUB- Ovulatory dysfunction (AUB-O), AUB-Leiomyoma (AUB-L), AUB-Adenomyosis (AUB-A).⁵ Adenomyosis is a condition in which the endometrium grows adjacent to the inner lining of the uterus, causing the uterine wall to grow in size causing heavy, painful, prolonged periods, and painful cramps.⁶

Peri menopausal Bleeding (PMB) is defined as the time from which changes in the pattern of the menstrual cycle are observed one year after the last menstrual period.⁷ This study was focused on the effectiveness and safety of Levonorgestrel IUD in abnormal uterine bleeding, adenomyosis and perimenopausal bleeding patients.

This study was conducted at the Department of Obstetrics and Gynecology, Krishna Institute of Medical Sciences (KIMS), Secunderabad after getting approval from the institutional ethical committee. It was a retrospective observational study with a sample size of 100 from the year 2015 to 2022 conducted in a tertiary care hospital. The brand name of the Levonorgestrel IUD used in this study was (MIRENA manufactured by Bayer Pharmaceuticals, USA.⁸ The data was collected from the KIMS hospital database). The institutional outcome scoring form included questions related to post-insertion side effects in 1 month, 6 months and 1 year. By following the answers of patients by contacting via phone we collected the information and gave outcome scoring. The Institutional Outcome Scoring form was used to get good, average and poor outcomes after insertion of the device in patients with AUB, Adenomyosis and PMB.

The inclusion criteria for the enrollment of female patients were between the ages 24 to 60 and with conditions like adenomyosis, AUB and PMB.

The exclusion criteria included confirmed or suspected pregnancy, abortion in the previous three months, renal dysfunction, liver dysfunction, malignant tumour, distorted uterine cavities and endometrial cancers like cervical cancer.

All the data collected were tabulated and categorized to apply statistical methods like frequency, percentage and one-way ANOVA to find the p-value. The data was collected by using patient reports.

In this study, we found that 57% of patients aged between 31 to 45, 39% were aged between 45 to 60, 2% were aged less than 30 and 2% were aged greater than 60. Table 1 represents that total of 100 patients was included in the study out of them 58% were AUB-E, 25% were AUB-A, 9% were AUB-L, 7% were PMB, 1% were AUB-C, p-value was found to be not significant. Our study implied that the most common condition among females was AUB-E.

Table 2 represents histopathological reports which imply that disordered Proliferative endometrium was most common in patients with 27%, 21% with proliferative endometrium, 20% with secretory endometrium and 21% with other findings (polyps, nil curetting) among 100 patients.

Clinical findings implied that a bulky uterus was the most common finding (59%) and the uterus was normal in 41%. Table 3 represents USG findings with 9% fibroids, 28% thickened endometrium and 24% adenomyosis changes.

Table 4 outlines post-insertion side effects, at 1 month we found spotting (44%) was the most common side effect followed by no side effect after insertion (43%), regular normal bleeding (12%) and expulsion was found in 1% of patients.

Table 5 outlines post-insertion side effects at 6 months in which we found regular normal bleeding in 50% of patients, decreased frequency of periods in 38.1% of the population, spotting in 6.57%, expulsion in 2.63% and removal in 2.63%. P value was found to be significant.

Table 6 outlines post-insertion side effects at 1 year, decreased frequency of periods in 46.8%, regular normal bleeding in 28.1% and amenorrhea in 25% of patients. P value was found to be significant.

Finally, in this study, we found that IUDs were safe and effective in 90% of patients and in 10% of patients it was removed, expelled or showed no effect.

In this study, we found that 57% of patients suffering from conditions like PMB, AUB and Adenomyosis were between 31 to 45 years of age and 2% were less than 30 years of age and greater than 60 years of age. Most common condition females presented with were AUB-E and the least common were PMB and AUB-C. Similar observations documented by Shyamala Kaitala et al. 2022 reported that a greater number of patients were suffering from AUB- A and HMB and the least were AUB-L.⁹ The number of patients suffering from AUB and the age group observed in our study is as per the earlier observations reported by Pallavi C. Dhamangaonkar et al. 2015.¹⁰ The findings of our study reflect that among the patients presented with AUB, PMB and Adenomyosis histopathological conditions, disordered proliferative endometrium was most common and secretory endometrium was less common In this study we found that in post-insertion side effects after 1, 6 and 12 months we found that spotting was more in 1^st month when compared to the 6^th month and 1-year, regular normal bleeding was less in 1^st month increased in 6^th month and again decreased after 1 year, Decreased frequency of periods after 6 months was found to be less when compared to 1 year, expulsion was seen after 1 month in 1% of patient and 2.63% of patients in 6^th month and no expulsion after 1year, removal of IUD due to severe side effects after 6^th month of insertion was seen in 2.63% of patients. The results are similar to the results observed by Pallavi C. Dhamangaonkar et al. 2015, and Gayatri Anipindi, and Vani I 2017 who concluded that Amenorrhea was reported in 73.3%, of heavy bleeding was found in 02.2% and spotting in 25% of patients after 1 year of insertion and Amenorrhea in 10% of patients at the end of 6 months and 40% at the end of 1 year respectively.^10–12 Overall, this study indicates that Levonorgestrel IUD is the safest and most effective with minimal side effects in conditions like AUB, Adenomyosis and PMB.

Levonorgestrel intrauterine device is effective and safe in conditions like Abnormal uterine bleeding, Adenomyosis and Peri menopausal bleeding with minimal side effects like spotting. The expulsion rate was also less when compared to other studies. The quality of life was improved in patients who were treated with IUD. To avoid surgery in AUB, Adenomyosis and PMB patients Levonorgestrel IUD was found to be safe and effective.

The limitation of the study includes the involvement of a small number of patients which gave a limited overview of postinsertion side effects and effectiveness of Levonorgestrel IUD in patients with AUB, Adenomyosis and PMB therefore further studies in this aspect involving a large number of patients with different age groups are necessary.

We would like to thank obstetrics and gynaecology department of Krishna Institute of Medical Sciences, Secunderabad, Telangana for hosting this research work. Our gratitude to all the people who have supported us in carrying out this research work successfully.