Role of Geminin as a Tool for Augmenting Accurate Diagnosis of Cervical Neoplasia.

AIM: To determine the role of geminin as a tool for differentiating various types of cervical intraepithelial neoplasia (CIN) and cervical carcinoma (CC). METHODS: Seventy women newly diagnosed with CIN or CC undergoing cervical biopsy were included; their clinical profile, human papilloma virus (HPV) positivity, and colposcopy findings were noted, and biopsy tissue was analyzed for geminin content. RESULTS: On geminin immunohistochemistry, 100% of women with CIN3 and 96.29% of women with CC had geminin two plus or more. When analyzed as ordinal variables, there was a significant correlation (spearman's rho 0.35, p 0.01) between geminin and biopsy results (CIN1, CIN2, CIN3, and CC). CONCLUSIONS: Screening tests for cervical cancer, like conventional pap smears, liquid-based pap smears, and triaging with HPV, have limitations. It is important to be able to differentiate between high-grade lesions, invasive cancer, and low-grade lesions. The detection of geminin in these cells may aid in the confirmation of the diagnosis and ensure adequate treatment. Cervical intraepithelial lesions and carcinoma cervix demonstrated a correlation between increased geminin expression in CIN1 vs. CC and CIN2 vs. CC. Geminin may be a potential surrogate marker for higher-grade cervical lesions, and further research is needed to corroborate evidence in this direction.

Antenatal factors and risk of postpartum hyperglycemia in women with gestational diabetes mellitus: A central India prospective cohort study.

Introduction: Global prevalence of gestational diabetes mellitus (GDM) ranges from <1% to 28%. Risk of postpartum diabetes (PPDM) is 7 times higher in women with GDM. We aimed to identify antenatal risk factors associated with postpartum hyperglycemia so that these women may be subjected to targeted screening in a low resource setting. Methods: Screening for GDM was done with a 75gram GTT using IADPSG criteria in women between 28-29 weeks and post-partum screening for hyperglycemia was done using 75 gm 2hour OGTT. Results: Mixed effect linear regression model to assess PPDM as outcome against age, pre pregnancy weight, baby weight at birth, HbA1C and postpartum BMI as predictors was significant at overall level (p=0.00). HbA1C (p =0.00) and pre pregnancy weight (p=0.001) were significant at individual level. Same model for postpartum prediabetes was significant at overall level and assumed significance for pre pregnancy weight (p=0.00), baby birth weight (p= 0.001), postpartum BMI (p=0.00) and HbA1C (p= 0.05) at individual level. The same model for postpartum abnormal sugars (PPDM or prediabetes) was significant at overall level (p = 0.00). Conclusion: Women with GDM represent a vulnerable population that is likely to develop a chronic metabolic disease at a young age exposing them to morbidity associated with unrecognized untreated hyperglycemia. Easily detectable clinical and biochemical antenatal risk factors may help identify women eligible for targeted screening for early diagnosis and treatment as well as use of preventive interventions against type2 diabetes after GDM.

The diagnostic accuracy of preoperative perfusion index as a predictor of postspinal anesthesia hypotension in parturients undergoing cesarean delivery: A prospective non-blinded observational study.

Background and Objectives: Spinal anesthesia is the technique of choice for elective cesarean section with a prominent side effect of postspinal anesthesia hypotension (PSH). This needs an early prediction to avoid feto-maternal complication. This study aimed to assess the diagnostic accuracy of perfusion index (PI) and inferior vena cava collapsibility index (IVCCI) in the prediction of PSH. Material and Methods: Thirty parturients of American Society of Anesthesiologists Physical Status (ASA-PS) 1 and two undergoing cesarean delivery participated in the study. IVCCI, PI, baseline systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and heart rate (HR) were noted in the preoperative period. The fall of MBP by 20% from baseline or below 65 mm Hg was considered PSH. After spinal anesthesia, SBP, DBP, MBP, and HR were noted again for diagnosing PSH. Results: It did not show any statistical difference when comparing the PI between the PSH and non-PSH groups in both the PSH definition groups. IVCCI was significantly higher when PSH was considered MBP <65 mm Hg (P = 0.01). However, IVCCI was found to be statistically insignificant if PSH was considered a 20% reduction in baseline MBP. The correlation matrix between IVCCI and PI showed Pearson's r-value of 0.525, indicating a substantial relationship between the two (P = 0.003). Multivariate logistic regression analysis had shown that neither IVCCI nor PI was a good predictor of PSH in parturients for both definition groups for PSH. Conclusion: Although there is a modest correlation between PI and IVCCI, both cannot be used to predict postspinal hypotension in parturients undergoing elective lower-segment cesarean section (LSCS).

Prevalence, Regional Variations, and Predictors of Overweight, Obesity, and Hypertension Among Healthy Reproductive-Age Indian Women: Nationwide Cross-Sectional Polycystic Ovary Syndrome Task Force Study.

BACKGROUND: A clear understanding of the anthropometric and sociodemographic risk factors related to BMI and hypertension categories is essential for more effective disease prevention, particularly in India. There is a paucity of nationally representative data on the dynamics of these risk factors, which have not been assessed among healthy reproductive-age Indian women. OBJECTIVE: This cross-sectional polycystic ovary syndrome (PCOS) task force study aimed to assess the anthropometric and sociodemographic characteristics of healthy reproductive-age Indian women and explore the association of these characteristics with various noncommunicable diseases. METHODS: We conducted a nationwide cross-sectional survey from 2018 to 2022 as part of the Indian Council of Medical Research-PCOS National Task Force study, with the primary aim of estimating the national prevalence of PCOS and regional phenotypic variations among women with PCOS. A multistage random sampling technique was adopted, and 7107 healthy women (aged 18-40 years) from 6 representative geographical zones of India were included in the study. The anthropometric indices and sociodemographic characteristics of these women were analyzed. Statistical analysis was performed to assess the association between exposure and outcome variables. RESULTS: Of the 7107 study participants, 3585 (50.44%) were from rural areas and 3522 (49.56%) were from urban areas. The prevalence of obesity increased from 8.1% using World Health Organization criteria to 40% using the revised consensus guidelines for Asian Indian populations. Women from urban areas showed higher proportions of overweight (524/1908, 27.46%), obesity (775/1908, 40.62%), and prehypertension (1008/1908, 52.83%) categories. A rising trend of obesity was observed with an increase in age. Women aged 18 to 23 years were healthy (314/724, 43.4%) and overweight (140/724, 19.3%) compared with women aged 36 to 40 years with obesity (448/911, 49.2%) and overweight (216/911, 23.7%). The proportion of obesity was high among South Indian women, with 49.53% (531/1072) and 66.14% (709/1072), using both World Health Organization criteria and the revised Indian guidelines for BMI, respectively. BMI with waist circumference and waist-to-height ratio had a statistically significant linear relationship (r=0.417; P<.001 and r=0.422; P<.001, respectively). However, the magnitude, or strength, of the association was relatively weak (0.3<|r|<0.5). Statistical analysis showed that the strongest predictors of being overweight or obese were older age, level of education, wealth quintile, and area of residence. CONCLUSIONS: Anthropometric and sociodemographic characteristics are useful predictors of overweight- and obesity-related syndromes, including prehypertension, among healthy Indian women. Increased attention to the health of Indian women from public health experts and policy makers is warranted. The findings of this study can be leveraged to offer valuable insights, informing health decision-making and targeted interventions that mitigate risk factors of overweight, obesity, and hypertension. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23437.

Normative range of various serum hormonal parameters among Indian women of reproductive age: ICMR-PCOS task force study outcome.

Background: The hormonal profile varies considerably with age, gender, ethnicity, diet or physiological state of an individual. Limited population-specific studies have studied the variations in hormonal parameters among apparently healthy women. We aimed to analyse the biological reference interval for various hormonal parameters in the reproductive-aged healthy Indian women. Methods: Out of 3877 participants that were clinically evaluated, 1441 subjects were subjected to laboratory investigations. All participants underwent a detailed clinical, biochemical and hormonal profiling. The hormone analysis was carried out at a single centre using a uniform methodology. Among the participants evaluated for biochemical and hormonal parameters, subjects that presented any abnormal profile or had incomplete investigations (n = 593) were excluded for further analysis. Findings: The mean age (±SD) of the subjects retained in the final analysis (n = 848) was 29.9 (±6.3) years. In the present study, the biological reference interval (2.5th-97.5th centile) observed were: serum T4: µg/dL (5.23-12.31), TSH: µg/mL (0.52-4.16) and serum prolactin: ng/mL (5.13-37.35), LH: mIU/mL (2.75-20.68), FSH: mIU/mL 2.59-15.12), serum total testosterone: ng/mL (0.06-0.68), fasting insulin: mIU/mL (1.92-39.72), morning cortisol: µg/dL (4.71-19.64), DHEAS:µg/dL (50.61-342.6) and SHBG: nmol/L (21.37-117.54). Unlike T4, TSH, LH, and E2, the biological reference interval for prolactin, FSH, testosterone, C-peptide insulin and DHEAS varied when the subjects were stratified by age (p < 0.05). The comparative analysis showed marginal differences in the normative ranges for the hormones analysed among different populations. Interpretation: Our first large composite data on hormonal measures will benefit future endeavours to define biological reference intervals in reproductive-aged Indian women. Funding: The study was financially supported by the grant-in-aid from ICMR vide file No:5/7/13337/2015-RBMH.

The immunohistochemical biomarker B-cell lymphoma-2 expression in malignant and premalignant lesions of the uterine cervix and its association with human papillomavirus infection.

Introduction: Cervical cancer is one of the leading causes of cancer deaths among women. It results due to human papillomavirus (HPV) infection. Cervical intraepithelial neoplasia (CIN) is the preinvasive condition of cervical cancer. Various objective immunohistochemical (IHC) markers have been studied for cervical cancer. This study is aimed at studying the expression of B-cell lymphoma-2 (Bcl-2) IHC marker among preinvasive and invasive lesions of cervical cancer and its association with HPV infection. Methodology: This prospective study was conducted over a period of 1 year in a tertiary care hospital in central India, included 73 women suffering from CIN and cancer cervix. The expression of Bcl-2 and the presence of HPV genotypes were studied. Results: Out of 73 patients, 34 had cancer cervix, out of which 15 (44%) had Bcl-2 positivity, 24 had CIN 1, out of which 13 (54%) had Bcl-2 positivity, 10 had CIN 2, out of which 4 (40%) had Bcl-2 positivity and 5 had CIN 3, out of which 3 (60%) had Bcl-2 positivity. No significant difference was found in Bcl-2 positivity among CIN-1, CIN-2, CIN-3, and cancer cervix cases with a Chi-square value of 1.116 and P = 0.77. HPV positivity was found in 41 (56%) out of 73 patients where HPV 16 subtype was the most common (31.5%), followed by HPV 18 (13.7%). No significant association between HPV positivity and Bcl-2 positivity was found with P = 0.34. Conclusion: Bcl-2 IHC seems to have variable expression among CIN cases. Although its expression is low among invasive cancer cases when compared with preinvasive lesions, the difference is not significant. Similarly, no significant association was found between Bcl-2 expression and HPV infections.

First-Trimester Reference Intervals for Thyroid Function Testing among Women Screened at a Tertiary Care Hospital in India.

Objectives Due to differences in the method of assay and population-specific factors, each laboratory needs to establish its own gestation-specific reference intervals (GRIs) for thyroid hormones. Materials and Methods Three-hundred forty-one women with less than 14 weeks gestation were screened at a tertiary care hospital in Chhattisgarh, India. Serum levels of thyroid-stimulating hormone (TSH), free thyroxine (fT4), and thyroid peroxidase antibody (anti-TPO) were measured using an ADVIA Centaur XP immunoassay. GRIs (2.5th and 97.5th percentiles) were determined for TSH and fT4. TSH and fT4 concentrations were converted to multiples of the median (MoM) values. Effect of maternal age, gestational age, and maternal weight was analyzed. Statistical Analysis Quantitative variables were expressed as means and standard deviations (SD), and qualitative variables were expressed as frequencies and percentages. Normality of the data was checked using the Kolmogorov-Smirnov test. Values that were normally distributed were expressed only as means and SD. Those that were not normally distributed were expressed as medians and interquartile range. For all statistical analysis, p < 0.05 was considered as statistically significant. Results First-trimester GRI was 0.245 to 4.971 mIU/L for TSH, 10.2 to 18.9 pmol/L for fT4, and 27.0 to 56.89 kIU/L for anti-TPO. There was no significant difference in the mean serum TSH ( p = 0.920), fT4 ( p = 0.714), or anti-TPO ( p = 0.754) values among women in 4 to 7th week and 7 to 14th week of gestation. The 1st and 99th centile MoMs were 0.03 and 4.09 for TSH and 0.66 and 1.39 for fT4. There was a significant positive correlation between the maternal weight and TSH MoM values ( p = 0.027, r = 0.120). Conclusion These laboratory- and first-trimester-specific GRI for TSH and fT4 shall help in proper diagnosis and treatment of subclinical thyroid dysfunctions. TSH and fT4 MoM values can be used to indicate high or low values in a quantitative manner independent of the reference ranges and may be used by other laboratories.

Serum testosterone level and semen quality in male patients with sickle cell disease in outpatient department of Chhattisgarh: a case-control study.

INTRODUCTION: Infertility issues in men with sickle cell disease (SCD) have been studied more frequently than those in women. Semen analysis of men with SCD often shows sperm abnormalities in up to 91%. No such study has been conducted in India so far, and Chhattisgarh being a state with a high incidence of male infertility as well as SCD, this study holds significance. OBJECTIVES: 1. To identify whether male patients attending All India Institute of Medical Sciences Outpatient Department with SCD have abnormal testosterone and/or poor semen quality. 2. Counseling of infertile male patients with SCD regarding future childbearing, prognosis, fertility preservation, and management options. METHODS: This study was an age-matched case-control study; 58 participants of age between 18-45 years were assigned in each group. RESULTS: The sperm count was higher in HbSS, while volume and pH were greater in HbAA. However, no significant difference (P>0.05) was found in total motility or progressive motility. A highly significant difference (P<0.001) was observed in pH, sperm count, total motility, and normal morphology. There was a significant difference (P=0.005) in volume. The values of the HbSS subjects were higher than the standard reference values. The values of the HbAA subjects were higher than the standard reference value. However, no significant difference (P>0.05) was found in sperm count or vitality. CONCLUSION: Men in Chhattisgarh with SCD do not suffer from any reproductive disorders such as delayed sexual maturity, low serum testosterone, poor semen quality, or hypogonadism.

Prediction of Preeclampsia Using First-Trimester Uterine Artery Doppler and Pregnancy-Associated Plasma Protein-A (PAPP-A): A Prospective Study in Chhattisgarh, India.

Introduction Preeclampsia is a major contributor of maternal and perinatal morbidity and mortality. Uterine artery waveform and biomarkers like pregnancy-associated plasma protein-A (PAPP-A) may reflect the pathophysiology of preeclampsia. Thus, we aim to find out whether abnormal uterine artery pulsatility index (PI) and low serum PAPP-A in the first trimester can predict preeclampsia. Methodology Antenatal women at 11-13+6 weeks of gestation visiting All India Institute Of Medical Science (AIIMS) in Raipur were enrolled after informed consent. Uterine artery Doppler was done with the early anomaly scan at 11-13+6 weeks. Serum levels of PAPP-A were analyzed. The women were followed up at intervals up to delivery. Incidence of preeclampsia and gestational hypertension was noted. Results The incidence of preeclampsia was 12.7%, and that of gestational hypertension was 4.9%. The mean uterine artery PI among those who developed hypertension in pregnancy was 2.007, which was significantly higher than the unaffected group (p=0.01). The first-trimester uterine artery PI as a screening tool showed a sensitivity of 68%, specificity of 52.99%, and detection rate (DR) of 55.63%. The mean PAPP-A MoM of the affected group was 0.67 which was significantly higher than the unaffected group (p<0.001). The first trimester PAPP-A as a screening tool showed a sensitivity of 28%, specificity of 90.6%, and DR of 79.58%. Conclusion Both the tests were concluded to be good predictors of hypertension in pregnancy. Identification of high-risk factors, screening, and surveillance are of utmost importance in order to predict preeclampsia and initiation of preventive therapy.

Experience, Challenges and Outcome of Implementing Universal New Born Hearing Screening in a Medical College Hospital Set Up.

In India, newborn hearing screening programs have been implemented as a part of research studies since early 1970s. Amongst the previously reported programs most are from the southern region and very few are from the west and the northern region of the country. There is a lack of evidence of such program in other region of the country. 1. To study the outcome, experience, and challenges faced during the implementation of the universal newborn hearing screening program in a medical college set up of Raipur, Chhattisgarh. 2. To determine the prevalence of hearing impairment with a two tier screening protocol with Otoacoustic emission and Auditory Brainstem Response. The Prospective Non randomised study was carried out between December 2017 and December 2019. A total of 1200 neonates delivered at the medical college, Raipur were screened using the two tier screening protocol. In our study, the prevalence of hearing loss was 2 per 1000 live births for bilateral hearing loss and 1 per 1000 live births for unilateral hearing loss. Implementing universal newborn screening in a vast country like India is a challenging task because of a high birth rate, diverse socio-economic and cultural background with limited resources. Though several hospitals and clinics have implemented the UNHS program, yet there is a dearth of literature regarding the program outcome, success, challenges, and lessons learnt. Therefore best practices of such evolved programs should be in public domain.

EEG-ERP Correlates of Cognitive Dysfunction in Polycystic Ovarian Syndrome.

Background: Polycystic ovarian syndrome (PCOS) has been shown to affect the psychological and cognitive status of a woman. However, amidst various conflicting reports in this regard, very few studies attempted to assess these aspects objectively using electroencephalography (EEG) and event-related potential (ERP). Purpose: To assess changes in neurocognitive and psychological parameters of PCOS women without any other comorbidities. Methods: PCOS women aged 18 years to 35 years, diagnosed from obstetrics and gynecology OPD who are otherwise free of any other comorbidities, were assessed for psychological status (anxiety and depression using the State-Trait Anxiety Inventory and Beck Depression Inventory, respectively). Thereafter, a cognitive assessment was done subjectively by the Montreal Cognitive Assessment (MoCA) questionnaire and objectively by using EEG [absolute and relative power of alpha, beta, and theta waves along with theta/beta ratios (TBR) and theta/alpha ratio (TAR)] and P300 amplitude and latency of ERP during a visual oddball paradigm task in control (n = 30) and PCOS (n = 37) subjects. Results: PCOS women showed significantly higher anxiety and depression scores along with low MoCA scores. Significantly reduced absolute alpha, increased frontal beta, and markedly increased theta (relative) power with increased TAR in the PCOS group were seen. Also, a significant reduction in P300 amplitude with prolonged latency during the visual oddball paradigm task was evident in them. Conclusion: Reduced alpha and higher theta activity with increased TAR are indicative of poor neural processing ability. Reduced P300 amplitude with more latency also suggests a cognitive decline, which is corroborated by reduced MoCA scores. Our study objectively indicates the presence of subclinical cognitive impairment in PCOS patients even without any comorbidities.

Effect of Exogenous Progesterone on Fetal Nuchal Translucency: An Observational Study.

Introduction Nuchal translucency is a reliable first trimester screening test for fetal structural and chromosomal defects. Neonates with increased nuchal thickness are at greater risk for anomalies. Exogenous progesterone supplementation may affect nuchal translucency and thus the first trimester anomaly screening. We aimed to study if there was a difference in nuchal thickness between women receiving progesterone in the first trimester compared to those who were not supplemented with progesterone. Material and methods Forty-seven women with documented progesterone intake in the first trimester for at least 10 continuous days before the day of the nuchal translucency scan served as the study group compared to 47 other women who did not receive progesterone. Nuchal translucency was measured between 11 and 13 weeks and six days of gestation. Results The mean nuchal translucency increased with increasing gestation in both groups. Maximum mean nuchal translucency was greatest in the age group 18-20 years (1.35 + 0.1 millimeters) in women receiving progesterone compared to 36-40 years (1.65 + 0.49 millimeters) in controls. The mean nuchal translucency in women receiving progesterone was 1.15 + 0.26 millimeters, and in those that did not receive progesterone, it was 1.23 + 0.35 millimeters (p = 0.314). Conclusions Nuchal translucency increased with increasing gestation in both groups, irrespective of progesterone supplementation. There was no significant difference in mean nuchal translucency in women supplemented with progesterone compared to those that did not receive progesterone in the first trimester.

Anxiety among pregnant women during the COVID-19 pandemic in India - A multicentric study.

While higher anxiety during antenatal period cause several maternal and foetal health related complications, lower anxiety levels are found to be associated with lesser "precautionary behaviours" and consequently greater risk of infection, during the COVID-19 pandemic. In this study, we aimed to assess rates and determinants of generalized anxiety at the time of the pandemic as well as anxiety that was specific to the context of being pregnant during the COVID-19 pandemic. (COVID-19-antenatal anxiety) in Indian women. This hospital-based, cross-sectional study using face-to-face interviews was conducted at antenatal clinics of five medical college hospitals in India. The Generalized Anxiety Disorder-7 scale (GAD -7) and a customized scale to assess antenatal COVID-19 anxiety along with other tools that assessed social support and COVID-19-risk perception were administered to 620 pregnant women. We found that the percentage of women with moderate or severe anxiety based on GAD -7 was 11.1%. Multivariate analysis showed that higher COVID-19-risk perception, greater antenatal COVID-19 anxiety and lower perceived support significantly predicted moderate and severe generalized anxiety. Greater number of weeks of gestation, lower education, semiurban habitat and lower perceived social support were significant predictors of antenatal COVID-19 anxiety. We conclude that the rates of anxiety in pregnant women though not very high, still warrant attention and specific interventions.

Favorable Pregnancy Outcome in a Granulomatosis With Polyangiitis Patient With Renal Insufficiency.

To present a case of successful pregnancy outcome in a granulomatosis with polyangiitis (GPA) patient with renal insufficiency. GPA, formerly known as Wegener's granulomatosis, is a rare necrotizing systemic vasculitis, presenting with classical clinical triad of manifestations involving upper and lower airway and glomerulonephritis. An association of Antineutrophil cytoplasmic antibodies with GPA has been established and the antibodies are present in most patients with active disease. Pregnancy with GPA is burdened with the risk of possible maternal and fetal complications, further leading to higher morbidity and mortality rate. Due to sparsity of studies of GPA in pregnancy, management needs to be individualised. Diagnostic workup should include serological markers, radiological and histopathological examination. Cyclophosphamide combined with prednisolone is the standard induction regimen. A 22-year-old woman, multigravida at 35 weeks of gestation was referred to our department owing to 1-year diagnosis of GPA. During active phase, the disease manifested as pneumonia and acute kidney injury and perinuclear anti-neutrophil cytoplasmic antibodies (P-ANCAs) were positive. She received pulse therapy of injection cyclophosphamide and methylprednisolone as induction regimen, followed by tapering doses of oral prednisolone and azathioprine for maintenance therapy. The disease was in remission at the onset of pregnancy but had flare up at 34 - 35 weeks of gestation and she presented with renal dysfunction. Neither the disease nor the treatment adversely affected the pregnancy and she delivered a healthy baby at 37 weeks. The unpredictable disease course and complications at unexpected gestation appears to be a major variable to take into account when assessing the risk of pregnancy with GPA. Early diagnosis, monitoring and timely intervention resulted in favourable pregnancy outcome in our patient.

Evaluation of the Prevalence, Regional Phenotypic Variation, Comorbidities, Risk Factors, and Variations in Response to Different Therapeutic Modalities Among Indian Women: Proposal for the Indian Council of Medical Research-Polycystic Ovary Syndrome (ICMR-PCOS) Study.

BACKGROUND: There is scanty data in India on polycystic ovary syndrome (PCOS) from several small, undersized, convenience-based studies employing differing diagnostic criteria and reporting varied regional prevalence. It is difficult to draw clear-cut conclusions from these studies; therefore, the present multicentric, well-designed, large-scale representative countrywide epidemiological study on PCOS across India was conceived with the aim to generate the actual prevalence rates of PCOS in India with a total sample size of approximately 9000 individuals. OBJECTIVE: The primary objectives of the study are to estimate the national prevalence of PCOS in India and the burden of comorbidities and to compare the variation in efficacy of standard therapeutic modalities for metabolic dysfunction in women with PCOS. METHODS: This multicentric umbrella study consists of three different substudies. Substudy 1 will involve recruitment of women aged 18-40 years using a multistage sampling technique from randomly selected polling booths across urban and rural areas to estimate national prevalence, phenotypic variation, and risk factors among regions. Substudy 2 involves recruitment of subjects from the community pool of substudy 1 and the institutional pool for quantitation of comorbidities among women with PCOS. Substudy 3, an interventional part of the study, aims for comparison of variation in efficacies of common treatment modalities and will be conducted only at 2 centers. The eligible consenting women will be randomized in a 1:1 ratio into 2 arms through a blinding procedure. All these women will undergo clinical, biochemical, and hormonal assessment at baseline and at 3 and 6 months. The data generated will be analyzed using the reliable statistical software SPSS (version 26). RESULTS: The study is ongoing and is likely to be completed by April 2022. The data will be compiled and analyzed, and the results of the study will be disseminated through publications. CONCLUSIONS: The Indian Council of Medical Research-PCOS study is the first of its kind attempting to provide accurate and comprehensive data on prevalence of PCOS in India. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2018/11/016252; ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=26366. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23437.

Role of various screening techniques in detecting preinvasive lesions of the cervix among symptomatic women and women having unhealthy cervix.

INTRODUCTION: Cervical cancer which is preventable, occurs due to humanpapiloma virus infection and results in a preinvasive condition called cervical intraepithelial neoplasm (CIN) before the development of cancer. Majority of the patients with CIN or early stage of cervical cancer present with symptoms such as abnormal vaginal discharge or bleeding, and unhealthy looking cervix. Selectively screening these symptomatic patients, can detect more number of positive cases and also most effective screening technique for these selective patients can be advocated. MATERIALS AND METHODS: All married women between 21 and 65 years attending gynecology outpatient department of a tertiary care health center in Central India and having unhealthy cervix or abnormal vaginal discharge were included. All women were subjected to Pap smear, visual inspection under acetic acid (VIA), visual inspection under Lugol's iodine (VILI) and colposcopy. Biopsy was taken in all cases. Diagnostic value of each screening method was determined in terms of sensitivity, specificity, positive predictive value and negative predictive value. RESULTS: Out of 352 patients, around 20% of them were found to have abnormal cytology. The sensitivity and specificity of Pap smear was found to be 34% and 94%. But colposcopy has high sensitivity and low specificity, i.e., 99% and 31%, respectively. On the other hand the sensitivity and specificity of VIA and VILI are comparable i.e., 65% and 45% and 64% and 48% respectively. Pap smear shows high positive predictive value among all, i.e., 85% and colposcopy shows 58% for the same. CONCLUSION: Pap smear carries low sensitivity but high positive predictive value. As compared to Pap smear, VIA and VILI are more sensitive and are of low cost. Colposcopy can be considered as a preferred method of screening due to its extremely high sensitivity.

Relationship of subclinical hypothyroidism and obesity in polycystic ovarian syndrome patients.

OBJECTIVES: To determine the prevalence of obesity and its relationship with subclinical hypothyroidism in women with polycystic ovarian syndrome (PCOS). To compare the clinico-biochemical parameters of obese and lean PCOS patients. MATERIALS AND METHODS: A total of 287 women with PCOS were included in this study after consent. The demographic, anthropometry, clinical, and hormonal (thyroid-stimulating hormone [TSH] and total testosterone) parameters were recorded along with pelvic ultrasonography (USG) for all PCOS subjects. They were divided into lean (body mass index [BMI] between 18.5 and 22.9) and overweight (BMI ≥23), and the number of subclinical hypothyroid patients were calculated in each group. The clinico-biochemical parameters of both groups were compared. RESULTS: The majority (61%) of our patients were overweight. There was no significant difference in the prevalence of subclinical hypothyroidism between overweight and lean PCOS patients. The obese PCOS patients were older than lean PCOS patients, and they had higher serum testosterone with elevated systolic and diastolic blood pressure (BP). CONCLUSION: The majority of our patients were found to be overweight and there was no association between obesity and subclinical hypothyroidism among PCOS patients.

Role of Saline Infusion Sonohysterography in Infertility Evaluation.

INTRODUCTION: Etiology of infertility is multifactorial, and fallopian tube abnormality being one of the most important causes accounts for up to 40% of female subfertility if not less and is further increasing. Saline infusion sonohysterography (SIS) procedure is gaining popularity and is being widely practiced and accepted as a screening tool in assessing tubal patency in infertile patients attending infertility clinic and has become popular as a routine test for the evaluation of the uterine cavity in the investigation of infertility and abnormal uterine bleeding. OBJECTIVE: To compare the results of SIS with that of hysterosalpingography in infertility evaluation and to observe the role of SIS to find out endometrial pathology and tubal patency in infertility patients. MATERIALS AND METHODS: A retrospective, observational study was done on the basis of record maintained in the ultrasound register and case record sheets of all infertile women who underwent infertility treatment and fulfilled the inclusion criteria from June 2015 to August 2016. RESULTS: SIS had sensitivity of 91%, specificity of 76% positive predictive value (PPV) of 95%, negative predictive value (NPV) of 66%, and accuracy of 89% of SIS in evaluating tubal patency. Further, SIS showed sensitivity of 83.3%, specificity of 60%, PPV of 75%, NPV of 75%, and accuracy of 72% in detecting pelvic pathology. CONCLUSION: In a low-resource country like India where patients are also less educated, SIS can prove to be a useful tool in initial workup of infertility patients with better compliance, low cost, and better results in a single visit.

Vitamin D Status and Cardio-Metabolic Risk in Indian Postmenopausal Women.

INTRODUCTION: The prevalence of chronic and non-communicable health disorders like cardiovascular diseases and metabolic syndrome is increasing worldwide including in India. The various risk factors for these health issues need to be addressed. The role of vitamin D deficiency in the causation of all these abnormal health conditions among postmenopausal women is a matter of debate now-a-days. AIM: To determine the correlation of serum vitamin D levels with various cardio-metabolic risk factors and metabolic syndrome (MetS) in postmenopausal women (PMW). MATERIALS AND METHODS: Total of 64 PMW were included in this cross-sectional study. Clinical (waist circumference, body mass index, blood pressure) and biochemical (fasting plasma glucose, lipid profile and serum 25-hydroxyl vitamin D levels) parameters were measured. MetS was defined using modified National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP-III) guidelines. Serum 25-hydroxyl vitamin D levels <50 nmol/l, between 52.5-72.5 nmol/l and >75 nmol/l were classified as deficient, insufficient and sufficient, respectively. RESULTS: MetS was prevalent in 33 (52%) subjects. There were no differences in serum vitamin D levels or proportion of vitamin D deficient individuals in those with and without MetS. 33 women (52%) had vitamin D deficiency. Cardio-metabolic risk profile was similar in both vitamin D deficient and replete women. CONCLUSION: Despite a high prevalence of vitamin D deficiency and MetS in Indian PMW, serum vitamin D concentrations do not correlate with the cardio-metabolic risk factors or MetS.

Association of Cytochrome-17 (MspA1) Gene Polymorphism with Risk of Gall Bladder Stones and Cancer in North India.

BACKGROUND: Cholelithiasis is associated in 54%-98% of patients with carcinoma of the gallbladder, and a high incidence among females suggests a role of female hormones in the etiology of the disease. Cytochrome P450C17α (CYP-17) is a key enzyme involved in estrogen metabolism and polymorphisms in CYP-17 are associated with altered serum levels of estrogens. Thus, we investigated whether the CYP-17 MspA1 gene polymorphism might impact on risk of gall bladder cancers or gallstones, as well as to determine if this gene polymorphism might be linked with estrogen serum levels and lipid profile among the North Indian gall bladder cancer or gallstone patients. MATERIALS AND METHODS: CYP-17 gene polymorphisms (MspA1) were genotyped with PCR-RFLP in cancer patients (n=96), stone patients (n=102), cancer+stone patients (n=52) and age/sex matched control subjects (n=256). Lipid profile was estimated using a commercial kit and serum estrogen was measured using ELISA. RESULTS: The majority of the patients in all groups were females. The lipid profile and estrogen level were significantly higher among the study as compared to control groups. The frequency of mutant allele A2 of CYP17 MspA1 gene polymorphism was higher among cancer (OR=5.13, 95% CI+3.10-8.51, p=0.0001), stone (OR=5.69, 95%CI=3.46-9.37, p=0.0001) and cancer+stone (OR=3.54, 95%CI=1.90-6.60, p=0.0001) when compared with the control group. However there was no significant association between genotypes of CYP17 MspA1 gene polymorphism and circulating serum level of estrogen and lipid profile. CONCLUSIONS: A higher frequency of mutant genotype A1A2 as well as mutant allele A2 of CYP-17 gene polymorphism is significantly associated with risk of gallbladder cancer and stones. Elevated levels of estrogen and an altered lipid profile can be used as predictors ofgall bladder stones and cancer in post menopausal females in India.