Safety and efficacy of two repeated cycles of ulipristal acetate in the management of symptomatic uterine fibroid among Indian women.

INTRODUCTION: To evaluate the safety and efficacy along with the impact on uterine and fibroid vascular indices of 2 repeat 12-week courses of ulipristal acetate (UPA) among Indian women. MATERIAL AND METHODS: Ninety-four premenopausal women aged 18-45 years with at least 1 symptomatic fibroid of size ranging from 1 cm to 10 cm were included in the study. All participants received 2 courses of 5 mg of UPA orally for 12 weeks starting from the 5th day of their menstrual cycle with a 2-menstrual-cycle break in between. The efficacy was measured in terms of time to amenorrhoea, percentage of women who achieved amenorrhoea for the last 35 consecutive days, reduction in uterine and fibroid volume, as well as its vascularity at the end of the first and second treatment cycle. RESULTS: Eighty-six women completed the first treatment cycle whereas only 65 women completed the second treatment course. Seventy-nine per cent of women achieved amenorrhoea for 35 consecutive days during the first treatment cycle. Median time to amenorrhoea was 7 days and 5 days during the first and second treatment cycle, respectively. Percentage reduction of the mean fibroid volume was 32% and 52% after the first and second treatment cycle, respectively. We observed an increase in fibroid vascular indices (pulsatility index and resistive index) suggesting reduction in fibroid vascularity. Serum oestradiol remained at mid-follicular phase. No serious drug emergent side effect was noted. CONCLUSIONS: Two interrupted repeat course of 5mg UPA is well tolerated efficient and safe in symptomatic fibroid among Indian women.

Serum Uric Acid Levels as a Risk Stratification Tool in Hypertensive Disorders of Pregnancy: A Retrospective Study.

BACKGROUND: Worldwide, hypertensive disorders of pregnancy (HDP) are among the leading causes of maternal and fetal morbidity and mortality. Serum uric acid is a test that can evaluate the severity of HDP and the associated maternal and fetal morbidity and mortality. AIM: To examine the relationship between maternal serum uric acid levels and the severity of HDP and overall pregnancy outcomes. MATERIAL AND METHODS: A retrospective study was conducted on women with a gestational age > 20 weeks and BP >140/90 mmHg over three years. A total of 134 patients were included in the study. Patients with chronic hypertension, hyperuricemia without hypertension, and other major illnesses were excluded. Data were collected from medical records, including age, gravida, parity, weight, height, gestational age, blood pressure at admission, urine albumin, and serum uric acid levels. RESULTS: Of the 134 enrolled women with HDP, 76 had gestational hypertension, 41 had preeclampsia, and 17 had eclampsia. Mean uric acid levels in mg/dL were 6.06±1.651, 6.20±0.824, and 7.38±1.26 in gestational hypertension, preeclampsia, and eclampsia, respectively, which was a significant association (p=0.002). Mean uric acid in mg/dL was 5.86±1.27 in intensive care unit (ICU) patients compared to 6.45±1.39 in ward patients (p=0.015). There was a significantly increased risk of ICU admission and preterm delivery (r=-0.401, p<0.001) in patients with elevated uric acid levels. There was a significantly increased risk of low-birth-weight babies with elevated uric acid levels (r=-0.278, p=0.001). However, there was no statistically significant increased risk of newborn intensive care unit admissions (p=0.264) with elevated uric acid levels. CONCLUSION: Serum uric acid levels vary significantly in HDP and were found to be elevated in severe preeclampsia and eclampsia. It can be considered for risk stratification in HDP based on disease severity; however, its role in determining outcomes is debatable. Using serum uric acid levels in predictive models along with known biomarkers may determine its possible additional value in disease prediction and severity.

Comparison of Bleeding Pattern and Quality of Life Before and After the Insertion of a Levonorgestrel Intrauterine System for Heavy Menstrual Bleeding: A Seven-Year Review.

Background This study aimed to examine the role of a levonorgestrel intrauterine system (LNG-IUS) in the treatment of heavy menstrual bleeding (HMB) regarding improvements in bleeding patterns and quality of life (QOL) and determine the reason for its failure or withdrawal from treatment in some patients. Methodology This retrospective study was conducted in a tertiary care center in eastern India. A seven-year assessment, with both qualitative and quantitative assessments, of the effect of LNG-IUS in women with HMB was performed using the Menorrhagia Multiattribute Scale (MMAS) and Medical Outcomes Study 36-Item Short-Form Health Survey (MOS SF-36) score as a tool to assess the QOL, and the pictorial bleeding assessment chart (PBAC) to assess bleeding patterns. The study population was divided into the following four groups based on duration: three months to one year, one to two years, two to three years, and more than years. The continuation, expulsion, and hysterectomy rates were evaluated. Results The mean MMAS and MOS SF-36 scores increased significantly (p < 0.05) from 36.73 ± 20.40 to 93.72 ± 14.62 and 35.33 ± 6.73 to 90.54 ± 15.89, respectively. The mean PBAC score decreased from 176.36 ± 79.85 to 32.19 ± 63.87. In total, 348 women (94.25%) continued the LNG-IUS, and 3.44% had uncontrolled menorrhagia. Furthermore, at the end of seven years, the expulsion rate was 2.28% due to adenomyosis and pelvic inflammatory disease, and the hysterectomy rate was 5.75%. In addition, 45.97% and 48.27% of the participants had amenorrhea and hypomenorrhea, respectively. Conclusions LNG-IUS improves bleeding and QOL in women with HMB. In addition, it requires less skill and is a non-invasive and nonsurgical option, which should be considered first.

Hysterectomy and women's health in India: evidence from a nationally representative, cross-sectional survey of older women.

BACKGROUND: Hysterectomy, particularly when conducted in women younger than 45 years, has been associated with increased risk of non-communicable diseases. In India, research indicates that hysterectomy is a common procedure for women, but there have been no studies on its long-term effects. We examined patterns of hysterectomy amongst women in India and associations with their health and well-being in later life. METHODS: This analysis utilised the first wave of the Longitudinal Study on Aging in India, a nationally representative study of adults that included a module on health and well-being. We analysed data on 35,083 women ≥45 years in India. We estimated prevalence of hysterectomy and performed multivariable logistic regression to identify associated risk factors and to examine the association between hysterectomy status and eight self-reported chronic conditions, hospitalisation and mobility. RESULTS: The prevalence of hysterectomy among women >=45 years was 11.4 (95% CI: 10.3, 12.6), with higher odds among urban women (aOR: 1.39; 1.17,1.64) and higher economic status (highest compared to lowest quintile: aOR: 1.95; 1.44, 2.63). Hysterectomy history was associated with four chronic conditions: hypertension (aOR: 1.51; 95% CI: 1.28, 1.79), high cholesterol (aOR: 1.43; 1.04, 1.97), diabetes (aOR: 1.69; 1.28, 2.24), and bone/joint disease (aOR: 1.54; 1.20, 1.97) and higher odds of any hospitalisation in the past year (aOR: 1.69; 1.36, 2.09). CONCLUSIONS: In India, evidence suggests that hysterectomy is associated with major chronic conditions. The assessment for hysterectomy as a treatment option for gynaecological morbidity should consider potential health consequences in later life.

The Appropriate Criteria in Patients Selection for Myomectomy in the Era of Minimally Invasive Surgery: A Case Report.

Background: Myoma is the most common benign monoclonal neoplasm of the uterus with increased frequency during reproductive years of women. Case Presentation: A twenty two year old female presented with abdomen lump, dysmenorrhoea, and heavy menstrual bleeding. Multiple myomas were diagnosed based on clinical and radiological findings. Abdominal myomectomy was performed and 75 myomas were enucleated followed by reconstruction of uterus. The second case was a 28 year old married woman presented with heavy menstrual bleeding and dysmenorrhoea. Ultrasound reported single posterior wall myoma of 8×6.3×5.8 cm in size. Laparoscopic myomectomy was performed. At follow-up visit, both cases were completely free of any symptoms. Conclusion: Myomectomy is a feasible and safe option and a uterine preserving surgery even in the presence of multiple myomas. Setting appropriate criteria in selecting patients for abdominal myomectomy rather than MIS is essential to avoid conversion and associated morbidity.

Modified WHO Partograph in Labour Room: A Quality Improvement Initiative to Find Out Concerns, Challenges and Solutions.

Every day many women die in pregnancy and childbirth, most of which are preventable. Regular and timely labour monitoring by partograph is of utmost importance. The aim of this study was to increase partograph use by residents in the Department of Obstetrics and Gynecology in all eligible women from existing 25% to 90% over six months through a quality improvement (QI) process. A team of six members including consultants, residents, and staff nurses did a root cause analysis through fishbone analysis to identify why the rate of use of partograph is only 25% of all cases. Many strategies were implemented through Plan-Do-Study-Act (PDSA) cycles for the cause identified. The interventions were allocation of triage area for timely identification of eligible women in the active phase of labour, training of residents, involving interns and nurses for use in shortage of staff, making departmental written policy, and assigning checking authority, to shift patients with attached partograph only; partograph has to be attached in the file right from the beginning when sisters make women admission file. These were done in five PDSA cycles and the outcome was measured by a control chart. The rate of partograph use increased from 25% to 92% over the study period of six months from September 2020 to February 2021. Regular audits were conducted to maintain the results. It can thus be concluded that partograph appears easy to implement and inexpensive, but its use still has enormous difficulties. But a QI approach can help in improving adherence to partograph use, by solving the root cause of the concern and challenges.

Study of Adaptability and Efficacy of Menstrual Cups in Managing Menstrual Health and Hygiene: A Descriptive Longitudinal Study.

Introduction Menstrual cup is a device made up of silicon for menstrual hygiene. Despite its being safe, eco-friendly, cheap, and durable its non-acceptability may be due to higher adoption barriers. We conducted this study to assess the adaptability and efficacy of menstrual cups. Methods It was a descriptive longitudinal study, conducted in a tertiary care institute in eastern India. Women of 18-50 years of age, educated till secondary level were included in the study, to be conducted over three months. The quantitative response for the satisfaction with the menstrual cup was measured on a five-point Likert scale after each menstrual cycle. Side effects, the quantity of blood flow and frequency of cleaning the menstrual cup, and how many participants will continue to use it were also asked. Results After the third menstrual cycle, 68.9% of participants stated that they would continue the menstrual cup usage. The mean total satisfaction score improved from 5.4 (first cycle) to 12.6 (third cycle) (p<0.001). The majority (67%) had no side effects, 10% had irritation and leakage, and 13% had an unpleasant odor. Conclusions The study shows that menstrual cups are a better alternative. Adaptability increases gradually through proper counseling, peer support, and practice.

Rate of premalignant and malignant endometrial lesion in "low-risk" premenopausal women with abnormal uterine bleeding undergoing endometrial biopsy.

OBJECTIVE: To determine the incidence of endometrial hyperplasia and endometrial cancer (EH/EC) in low-risk premenopausal women with abnormal uterine bleeding (AUB) undergoing endometrial biopsy and to build a predictive model that includes clinical variables for predicting EH/EC in these women. METHODS: This retrospective study was conducted between January 2015 and March 2020. All premenopausal women aged <55 years with AUB who underwent endometrial sampling during a specified time period were included. Data regarding baseline characteristics, sonographic findings, and histological reports were collected from patient record sheets. RESULTS: During the specified time period, 1,089 premenopausal women underwent endometrial biopsy for AUB. Complete data analysis was done for 1,084 women. Of the endometrial samples, 95.3% revealed benign pathology, whereas 4.7% of the samples had major endometrial pathology EH/EC. On step-wise logistic regression analysis, intermenstrual bleeding (IMB) (OR, 3.15), body mass index (BMI) >25 kg/m2 (odds ratio [OR], 4.4705), age >40 years (OR, 1.14), endometrial thickness (ET) >13 mm (OR, 2.59), and hypothyroidism (OR, 1.35) were significantly associated with EH/ EC. Considering the pretest probability for an EH/EC of 4.7%, this prediction model with a likelihood ratio of 14.2% demonstrated a post-test probability of 41% in the presence of the above-mentioned variables. CONCLUSION: The risk of EH/EC was lower in low-risk premenopausal women with AUB. However, premenopausal women with IMB aged >40 years, hypothyroidism, BMI >25 kg/m2, and thickened endometrium (ET >13 mm) are at high risk of EH/EC; therefore, endometrial biopsy should be considered early in their management plan.

Impact of polycystic ovary syndrome on quality of life of women in correlation to age, basal metabolic index, education and marriage.

Polycystic ovary syndrome (PCOS) is the major endocrine related disorder in young age women. Physical appearance, menstrual irregularity as well as infertility are considered as a sole cause of mental distress affecting health-related quality of life (HRQOL). This prospective case-control study was conducted among 100 PCOS and 200 healthy control cases attending tertiary care set up of AIIMS, Patna during year 2017 and 2018. Pre-validated questionnaires like Short Form Health survey-36 were used for evaluating impact of PCOS in women. Multivariate analysis was applied for statistical analysis. In PCOS cases, socioeconomic status was comparable in comparison to healthy control. But, PCOS cases showed significantly decreased HRQOL. The higher age of menarche, irregular/delayed menstrual history, absence of child, were significantly altered in PCOS cases than control. Number of child, frequency of pregnancy, and miscarriage were also observed higher in PCOS cases. Furthermore, in various category of age, BMI, educational status and marital status, significant differences were observed in the different domain of SF-36 between PCOS and healthy control. Altogether, increased BMI, menstrual irregularities, educational status and marital status play a major role in altering HRQOL in PCOS cases and psychological care must be given during patient care.