The dynamics of SARS-CoV-2 infection in unvaccinated and vaccinated populations in Mumbai, India, between 28 December 2020 and 30 August 2021.

The emergence and evolution of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants that could compromise vaccine efficacy (VE) with re-infections in immunized individuals have necessitated continuous surveillance of VE. Here, the occurrence and dynamics of SARS-CoV-2 infections in the context of vaccination during the second wave of infection in Mumbai were evaluated. RT-PCR cycle threshold (Ct) values of the open reading frame (ORF)/envelope (E)/nucleocapsid (N) genes obtained from a total of 42415 samples, comprising unvaccinated (96.88%) and vaccinated cases (3.12%) were analyzed between December 28, 2020, and August 30, 2021. A lower incidence of SARS-CoV-2 infection in fully vaccinated cases (5.07%) compared to partially vaccinated cases (6.5%) and unvaccinated cases (13.453%) was recorded. VE was significant after the first dose of vaccination (ORF gene p-value = 0.003429, and E/N gene p-value = 0.000866). Furthermore, VE was observed to be significant when the post-immunization (first dose) period was stratified to within 30 days (ORF gene p-value = 0.0094 and E/N gene p-value = 0.0023) and to 60 days following the second dose of vaccination (ORF gene p-value = 0.0238). Also, significantly higher efficacy was observed within individuals receiving two doses compared to a single dose (ORF gene p-value = 0.0132 and E/N gene p-value = 0.0387). The emergence of breakthrough infections was also evident (odds ratio= 0.34; 95% confidence interval= 0.27-0.43). Interestingly, viral loads trended towards being higher in some groups of partially vaccinated individuals compared to completely vaccinated and unvaccinated populations. Finally, our results delineated a significantly higher incidence of SARS-CoV-2 acquisition in males, asymptomatic individuals, individuals with comorbidities, and those who were unvaccinated.

Incidence & factors influencing maternal near miss events in tertiary hospitals of Maharashtra, India.

Background & objectives: Government of India (GoI) released operational guidelines for maternal near miss-review (MNM-R) in 2014 for use by programme managers of public health system to assist them for conducting MNM-R. The objective of the present study was to review the incidence and factors influencing MNM events in two tertiary hospitals of Maharashtra, India, as per the operational guidelines of the GoI released in 2014 and identify delays based on three-delay model to prevent such events in future. Methods: This prospective observational study was conducted in two tertiary hospitals of Maharashtra, from July 2018 to November 2020. All women during pregnancy, childbirth or postpartum upto 42 days meeting the eligibility criteria of MNM as per the 2014 GoI guidelines were included as cases (n=228), interviewed and discussed during the monthly MNM meetings at these hospitals. Results: The incidence of MNM was 11/1000 live births; the ratio of MNM to maternal deaths was 1.2:1. Leading causes of MNM were haemorrhage (36.4%) and hypertensive disorders of pregnancy (30.3%). Haemorrhage was maximum (70.6%) in abortion and ectopic pregnancies. Majority of the women (80.2%) were anaemic, of whom 32.4 per cent had severe anaemia. Eighty six per cent of women included in the study had MNM events at the time of admission and 81 per cent were referred from lower facilities. Level one and two delays were reported by 52.6 and 32.5 per cent of women, respectively. Level three delay at referral centres and at tertiary hospitals was reported by 69.7 and 48.2 per cent of women, respectively. Interpretation & conclusions: The findings of this study suggest that MNM-R should be undertaken at all tertiary hospitals in India as per GoI guidelines to identify gaps based on three-delay model. These hospitals should implement interventions as per the identified gaps with emphasis on strengthening the infrastructure, facilities and manpower at the first-referral units.

Association of traditional marital practices with contraceptive decision-making, couple communication, and method use among couples in rural Maharashtra, India.

In India, traditional social practices around marriage, such as non-involvement of prospective brides in choice of partner and timing of marriage, child/early marriage, dowry and purdah, compromise women's agency at the time of marriage and may also affect contraceptive practices in marriage. This paper examines the associations between traditional marital practices and contraceptive behaviours, including women's control over contraceptive decision-making, couples' communication about contraception, and ever use of contraceptives, among married women aged 18-29 years (N = 1,200) and their husbands in rural Maharashtra, India. Multivariable logistic regression was used to examine the association between these marginalising social practices and family planning behavioural outcomes, adjusting for demographic and parity confounders. Wives who were the primary decision-makers on who to marry had higher odds of ever having communicated with their husband on pregnancy prevention (AOR 1.76, 95% CI 1.16-2.68), and ever using modern contraceptives (AOR 2.19, 95% CI 1.52-3.16). Wives who were the primary decision-makers on when to marry also had higher odds of ever having used modern contraceptives (AOR 1.86, 95% CI 1.21-2.93). Women's involvement in marital choice may facilitate couples' engagement related to family planning, possibly via the establishment of better communication between partners.

Missing men in family planning: understanding the socio-spatial differentials in male sterilization and male spacing methods of contraception in India.

Male involvement in family planning results in improved reproductive health and gender outcomes for women. In India, the use of family planning methods remains largely female-dominated. Recent media reports have indicated a rapid decline in male sterilization use in the past few years. This study aimed to assess the trends in, patterns of and factors associated with the use of male sterilization and male spacing methods in India using data from four rounds of the National Family Health Survey, conducted from 1992 to 2016. Bivariate analysis was done to see the trends in, and patterns of, male sterilization and spacing methods, while multinomial logistic regression was used to understand the factors associated with male spacing methods and sterilization. The results show a marked decline in the prevalence of male sterilization from 1992-93 (3.5%) to 2015-16 (0.3%) in India. Of the 640 districts, only 21 had a more than 2% prevalence of male sterilization. Scheduled tribe couples were two times more likely to use male sterilization than other (upper/no caste) groups. Couples from the northern region were significantly more likely to use male sterilization (aOR: 1.68, 95% CI: 1.43-1.97) compared with those from the south. There was a regional disparity in male condom use, with a very small proportion of couples in the southern (1.1%), north-eastern (2.4%) and eastern (3.3%) regions using the method compared with couples from the northern region (9.7%). Couples from the northern (aOR: 8.89, 95% CI: 8.44-9.38), north-eastern (aOR: 11.37, 95% CI: 10.62-12.18), eastern (aOR: 6.96, 95% CI: 6.60-7.34), western (aOR: 4.65, 95% CI: 4.40-4.92) and central (aOR: 10.89, 95% CI: 10.35-11.46) regions were also significantly more likely to use male spacing methods than those from southern India. Therefore, a greater focus on increasing the use of male sterilization and condoms is required in India to reduce the gender disparity in the use of family planning methods.

Health system cost for providing antiretroviral therapy, family planning, and pregnancy-related services to women living with HIV in public health settings, Mumbai, India.

Background: Integration of HIV care into family planning (FP) services would help in reducing unintended pregnancies among women living with HIV. Objectives: This study focuses on determining the health system cost for providing the linked HIV-FP services per beneficiary for the year 2019-2020. Materials and Methods: Using mixed micro-costing approach costs were collected from two tertiary hospitals in Maharashtra, India. The economic costs collected from gynaecology department and anti-retroviral treatment center were combined and added with package, program, and intervention costs to obtain health-system costs. We conducted probabilistic sensitivity analysis. Results: The unit cost and annual per-capita cost for providing HIV care (without considering cost of drugs and investigations) per beneficiary were INR 1033.8 (USD 13.6) and INR 9304.2 (USD 122.7), respectively. The unit cost was least for the outpatient services INR 197.5 (USD 2.6), followed by inpatient services INR 2735.92 (USD 36.21) and operation theater INR 4410 (USD 58.2). Cost was highest for dual-permanent (INR 13866.8 [USD 182.9]) followed by dual-reversible user (INR 2104.8 [USD 24.8]). It was the least for a person who only used condoms at INR 1674.1 (USD 22.1). In pregnancy-related services, cost for ante-natal services was least (INR 2043.6 [USD 27.96]), followed by vaginal delivery (INR 7120.5 [USD 93.93]), abortion (INR 11530.5 [USD 152.097]), and C-section (INR 18703.8 [USD 246.7]). Conclusion: We found no staggeringly additional costs for providing FP and pregnancy-related services to HIV-affected population, in comparison to general population. The findings could improve programs and insurance with a focus on this vulnerable population.

Associations between Contraceptive Decision-Making and Marital Contraceptive Communication and use in Rural Maharashtra, India.

Women's contraceptive decision-making control is crucial for reproductive autonomy, but research largely relies on the Demographic and Health Survey (DHS) measure which asks who is involved with decision-making. In India, this typically assesses joint decision-making or male engagement. Newer measures emphasize female agency. We examined three measures of contraceptive decision-making, the DHS and two agency-focused measures, to assess their associations with marital contraceptive communication and use in rural Maharashtra, India. We analyzed follow-up survey data from women participating in the CHARM2 study (n = 1088), collected in June-December 2020. The survey included the DHS (measure 1), Reproductive Decision-Making Agency (measure 2), and Contraceptive Final Decision-Maker measures (measure 3). Only Measure 1 was significantly associated with contraceptive communication (adjusted odds ratio [AOR]: 2.75, 95 percent confidence interval [CI]: 1.69-4.49) and use (AOR: 1.73, 95 percent CI: 1.14-2.63). However, each measure was associated with different types of contraceptive use: Measure 1 with condom (adjusted relative risk ratio [aRRR]: 1.99, 95 percent CI: 1.12-3.51) and intrauterine device (IUD) (aRRR: 4.76, 95 percent CI: 1.80-12.59), Measure 2 with IUD (aRRR: 1.64, 95 percent CI: 1.04-2.60), and Measure 3 with pill (aRRR: 2.00, 95 percent CI: 1.14-3.52). Among married women in Maharashtra, India, male engagement in decision-making may be a stronger predictor of contraceptive communication and use than women's agency, but agency may be predictive of types of contraceptives used.

An integrated multidisciplinary model of care for addressing comorbidities beyond reproductive health among women with polycystic ovary syndrome in India.

Background & objectives: Polycystic Ovary Syndrome (PCOS) is becoming an area of global and national health concern. It requires a life cycle approach from adolescence to menopause. To comprehensively address the wide spectrum of this disorder, a multidisciplinary model of care was established for women with PCOS in a government setting in India with an objective to screen and manage multifaceted manifestations of PCOS and to diagnose and treat associated comorbidities such as metabolic syndrome, dermatologic manifestations and psychological issues. Methods: A model of integrated multidisciplinary PCOS clinic was implemented for services and research at ICMR-National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai Maharashtra, India. This is a one-stop holistic centre for managing menstrual, cosmetic, infertility, obesity, metabolic and psychological concerns of women affected with PCOS. Two hundred and twenty six women diagnosed with PCOS using the Rotterdam criteria were screened for metabolic comorbidities with anthropometry, ultrasonography, hormonal and biochemical tests and for psychological problems. Analysis was performed using SPSS version 19.0. Results: Mean body mass index (BMI) was 26.1 kg/m2, higher for Asians. Hirsutism was observed in 53.6 per cent of women. Metabolic syndrome was seen among 35.3 per cent and non-alcoholic fatty liver in 18.3 per cent. Psychological issues such as anxiety and depression were identified in majority of the women 31.4 per cent of women could achieve pregnancy at the end of one year of multidisciplinary management. Interpretation & conclusions: The results of the present study suggest that an integrated multidisciplinary approach led to the early identification and treatment of comorbidities of PCOS, especially metabolic syndrome. There is hence an urgent need to implement multidisciplinary PCOS clinics in government health facilities.

Evaluation of cytokine profile in cervicovaginal lavage specimens of women having asymptomatic reproductive tract infections.

Reproductive tract infections (RTIs) such as vaginal candidiasis and bacterial vaginosis (BV) are common among sexually active women and can be both symptomatic or asymptomatic. The microbiota of the reproductive tract triggers immune response at the cervicovaginal interface resulting in secretion of cytokines during the course of these RTIs. The objective of this study was to evaluate the cytokine profile in cervicovaginal lavage of women having asymptomatic vaginal infections. Measurement of vaginal cytokines was done for various interleukins including IL-1ß, IL-6, IL-8, IL-10, IL-12/IL23p40, IL-17A, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) by ProcartaPlex™ Multiplex Immunoassay. Women having vaginal Candida infection had increased concentration of IL-1ß (p=.01), IL-6 (p=.007), IL-8 (p=.327), IL-12/IL23p40 (p=.049) and IFN-γ (p=.125). The results of our study suggest that evaluation of these cytokines could be explored as an additional measure to determine host inflammatory response in women having asymptomatic vaginal candidiasis.Impact StatementWhat is already known on this subject? Studies assessing the vaginal cytokine profile to assess the vaginal milieu in various cohorts such as post-menopausal women, pregnant women, women with history of preterm birth, CIN and scheduled IVF cycle are being undertaken. Variable cytokine response has been reported in literature in women with symptomatic bacterial vaginosis and Candida infection. However, much less is known about vaginal cytokine profile in asymptomatic infection.What do the results of this study add? The results of the study show increased concentration of the pro-inflammatory cytokines IL-1ß, IL-6 IL-8, IL-12/IL23p40 and interferon gamma (IFN-γ) in women having asymptomatic Candida, vaginal leucocytosis and raised vaginal pH.What are the implications of these findings for clinical practice and/or further research? Evaluation of vaginal cytokine profile (IL-1ß, IL-6 IL-8, IL-1ß, IL-12/IL23p40 and IFN-γ) could be explored as an additional measure to determine inflammation in asymptomatic women. Vaginal cytokines (IL-1ß, IL-6 IL-8, IL-1ß, IL-12/IL23p40 and IFN-γ) could be used further for development of a point of care test.

Maternal near miss events in India.

Background & objectives: Maternal morbidity is an indicator of the quality of a country's maternal health services. Maternal near miss (MNM) can provide valuable information in this context and hence these cases need to be reviewed which can indirectly play a major role in reducing maternal mortality ratio in India. The objectives of the present review were to find the prevalence/incidence, criteria used for identification, review the causes of MNM cases and identify the contributory factors responsible for the occurrence of these cases based on three-delay model. Methods: Articles were identified from the PubMed, Google Scholar, Scopus and Cochrane Library using search terms such as 'Maternal Near Miss','maternal morbidity', 'India' among others. All health facility-based observational studies conducted in India published between 2010 to 2019 irrespective of data collection period, and criteria used for identification of MNM cases were included for review. Data were extracted from included studies and summarized in terms of prevalence/incidence, ratio and percentage. Results: Out of 25 studies, majority were prospective observational conducted at government health facilities. The incidence of MNM varied widely from 3.9 to 379.5 per 1000 live births and 7.6-60.4 per 1000 deliveries. MNM: Maternal Death varied from 1.7:1 to 21.8:1; studies used different criteria to define MNM cases. Interpretation & conclusions: Hypertensive disorders and anaemia were the leading direct and indirect causes of MNM, respectively. There was a lack of uniformity in using the criteria for MNM across studies conducted in India over the last decade. Future studies on MNM in India should follow the uniform criteria mentioned in the MNM-Review guidelines released by the Government of India in 2014 for obtaining systematic data and proper summary estimates.

Male-female concordance in reported involvement of women in contraceptive decision-making and its association with modern contraceptive use among couples in rural Maharashtra, India.

OBJECTIVE: Women's involvement in contraceptive decision-making increases contraceptive use and reduces unmet need, but study of this has been limited to women's self-reports. Less research is available examining couple concordance and women's involvement in contraceptive decision-making as reported by both men and women. STUDY DESIGN: We carried out a cross-sectional study using data from rural India (N = 961 young married couples). Using multivariable regression we examined the association between concordance or discordance in spousal reports of wife's involvement in contraceptive decision-making and modern contraceptive use, adjusting for demographics, intimate partner violence, and contraceptive use discussion. RESULTS: More than one third (38.3%) of women reported current modern contraceptive use. Report of women's involvement in contraceptive decision-making showed 70.3% of couples agreed that women were involved, jointly or alone (categorized as Concordant 1), 4.2% agreed women were not involved (categorized at Concordant 2), 13.2% had women report involvement but men report women were uninvolved (categorized as Discordant 1), and 12.2% had women report uninvolvement but men report that women were involved (categorized as Discordant 2). Discordant 2 couples had lower odds of modern contraceptive use relative to Concordant 1 couples (adjusted RR = 0.61, 95% CI 0.45-0.83). No other significant differences between Concordant 1 couples and other categories were observed. CONCLUSION: One in four couples indicated discordance on women's involvement in contraceptive decision making, with Discordant 2 category having lower odds of contraceptive use. Couples' concordance in women's involvement in contraceptive decision-making offers a target for family planning research and interventions to better meet their needs. Trial registration ClinicalTrial.gov, NCT03514914. https://clinicaltrials.gov/ct2/show/NCT03514914.

Evidence on women's involvement in decision-making are limited to women's self reports and often not specific to contraceptive decision-making. This study uses couples dyadic data to assess male­female concordance on women's involvement in contraceptive decision-making and contraceptive use outcomes. Couple's concordance on women's involvement in contraceptive decision-making is associated with contraceptive use. There is potential in couple-focused family planning counseling that enhances women's contraceptive decision-making agency to improve women's contraceptive use.

Discordance between TST and QFT-TBGold Plus for Latent Tuberculosis Screening among Under-Five Children: An Interim Analysis.

AIM: To analyze the agreement between tuberculin skin test (TST) and fourth-generation QuantiFERON (QFT)-TB Gold Plus [interferon gamma (INF-γ) release assays (IGRA)] for latent tuberculosis infection (LTBI) diagnosis among under-five children who are undernourished and/or who have history of contact with active tuberculosis (TB) patients. METHODS: Children from the age group of 6 months to 5 years (undernourished or tuberculosis household contacts) were screened through anganwadis (government playschools) and TB Health posts from Mumbai, India during September 2019 to January 2021. Both TST and QFT-TB Gold Plus test were carried out to diagnose LTBI. RESULTS: Out of the total 299, 35 (11.7%) (95% CI 8.1-15.3%) children tested positive by IGRA (QFT-TB Gold Plus) and 68 (22.7%) (95% CI 18.0-27.4%) by TST, suggestive of moderate concordance (κ = 0.483) between both tests. IGRA and TST showed moderate concordance in children <24 months (κ = 0.478). Moreover, 26 (21.1%) children with TB contact had both TST and IGRA positive with moderate concordance (κ = 0.550). A fair concordance (κ = 0.396) was observed between IGRA and TST in undernourished children. Also, 45 (15.0%) children showed discordance of which 39 (13.0%) had positive TST but negative IGRA and 6 (2.0%) had negative TST but positive IGRA. CONCLUSIONS: The study strongly recommends both TST and QFT-TB Gold Plus test for the diagnosis of LTBI in under-five children. A moderate concordance in children <24 months endorses the reliability of QFT-TB Gold Plus in diagnosing LTBI in this age group. This study highlights the need for screening undernourished children for LTBI to consider repeating IGRA testing for TST positives as per the window period and risk of ongoing exposure.

The current study focuses on discordance and concordance between tuberculin skin test (TST) and fourth-generation QuantiFERON (QFT)-TB Gold Plus [interferon gamma (INF-γ) release assays (IGRA)] for latent tuberculosis infection (LTBI) diagnosis among at-risk under-five children who are underweight and/or who have history of contact with active tuberculosis patients. The IGRA prevalence came out to be 11.7% (95% CI 8.1­15.3%) whereas the TST prevalence turned out to be 22.7% (95% CI 18.0­27.4%). A stronger concordance was observed between IGRA and TST among the age group of 2 to 5 years, and a relatively fair one for children below the age of 1 year. The present study strongly recommends to include both TST and IGRA test for the diagnosis of LTBI with respect to Indian pediatric population. This study also suggests the importance of repetition of IGRA for TST positive patients. Another vital opinion that is showcased in the present study is the inclusion of undernourished pediatric population residing in at-risk areas like urban slums for routine LTBI screening programs.

Vision-Based Driver's Cognitive Load Classification Considering Eye Movement Using Machine Learning and Deep Learning.

Due to the advancement of science and technology, modern cars are highly technical, more activity occurs inside the car and driving is faster; however, statistics show that the number of road fatalities have increased in recent years because of drivers' unsafe behaviors. Therefore, to make the traffic environment safe it is important to keep the driver alert and awake both in human and autonomous driving cars. A driver's cognitive load is considered a good indication of alertness, but determining cognitive load is challenging and the acceptance of wire sensor solutions are not preferred in real-world driving scenarios. The recent development of a non-contact approach through image processing and decreasing hardware prices enables new solutions and there are several interesting features related to the driver's eyes that are currently explored in research. This paper presents a vision-based method to extract useful parameters from a driver's eye movement signals and manual feature extraction based on domain knowledge, as well as automatic feature extraction using deep learning architectures. Five machine learning models and three deep learning architectures are developed to classify a driver's cognitive load. The results show that the highest classification accuracy achieved is 92% by the support vector machine model with linear kernel function and 91% by the convolutional neural networks model. This non-contact technology can be a potential contributor in advanced driver assistive systems.

Significance of Vitamin D Binding Protein in Assessing Vitamin D Status Among Under-Five Children.

Despite ample sunshine, 50-90% Indian children have Vitamin D deficiency (VDD). This enigma of widespread VDD needs exploration especially among under-fives as physiological variations in Vitamin D Binding Protein (VDBP) levels could be potential confounders in the interpretation of total 25-hydroxyvitamin D [25(OH)D]. However, there is scarce information about relevance of VDBP levels in under-five age group. We therefore, explored association of VDBP levels among 1-5 year old children with VDD. Serum levels of 25(OH)D, VDBP, calcium, parathyroid hormone (PTH) and alkaline phosphatase were estimated in 210 apparently healthy children in the age group of 1-5 years. VDD was defined as serum 25(OH)D levels < 20 ng/ml as per the IOM classification. VDBP levels were classified as low if levels were < 168 µg/ml as per the kit. The prevalence of VDD was 79.5% (n = 167) and VDBP levels were low in 48.6% (n = 102) of children. 25(OH)D levels correlated positively with VDBP (r = 0.298, p = 0.0001). A significant number of children (52.7%) with VDD had low VDBP (p = 0.015). and despite adequate sun exposure, 43% of children showed VDD and 56.6% had low VDPB levels. The low VDBP levels largely explain low 25OHD levels without necessarily implying VDD. It may add a new dimension for better understanding of widespread VDD among under-five children. It thus, points towards the need for redefining cut offs and complete evaluation of vitamin D status among under-fives including VDBP.

Childhood dietary patterns and body composition at age 6 years: the Children of SCOPE study.

Dietary patterns describe the quantity, variety, or combination of different foods and beverages in a diet and the frequency of habitual consumption. Better understanding of childhood dietary patterns and antenatal influences could inform intervention strategies to prevent childhood obesity. We derived empirical dietary patterns in 1142 children (average age 6.0 (0.2) years) in Auckland, New Zealand whose mothers had participated in the Screening for Pregnancy Endpoints (SCOPE) cohort study and explored associations with measures of body composition. Participants (Children of SCOPE) had their diet assessed by food frequency questionnaire (FFQ) and empirical dietary patterns were extracted using factor analysis. Three distinct dietary patterns were identified; 'Healthy', 'Traditional' and 'Junk'. Associations between dietary patterns and measures of childhood body composition (waist, hip, arm circumferences, body mass index (BMI), bioelectrical impedance analysis (BIA) derived body fat percentage, and sum of skinfold thicknesses (SST)) were assessed by linear regression, with adjustment for maternal influences. Children who had higher 'Junk' dietary pattern scores had 0.24cm greater arm (0.08 SD (95%CI 0.04, 0.13)) and 0.44cm hip (0.05 SD (95% CI 0.01, 0.10)) circumferences, 1.13cm greater SST (0.07 SD (95%CI 0.03, 0.12)) and were more likely to be obese (OR=1.74 (95%CI 1.07, 2.82)); those with higher 'Healthy' pattern scores were less likely to be obese (OR=0.62 (95%CI 0.39, 1.00)). In a large mother-child cohort, a dietary pattern characterised by high sugar and fat foods was associated with greater adiposity and obesity risk in children aged 6 years, while a 'Healthy' dietary pattern offered some protection against obesity. Targeting unhealthy dietary patterns could inform public health strategies to reduce the prevalence of childhood obesity.

Knowledge of symptoms and risk factors of breast cancer among women: a community based study in a low socio-economic area of Mumbai, India.

BACKGROUND: Breast cancer (BC) is leading cancer among women in India accounting for 27% of all cancers among women. Factors that make the policymakers and public health system worried are rising incidence of breast cancer in India and more importantly high death rates among breast cancer patients. One of the leading causes of high breast cancer deaths is lack of awareness and screening leading to the late presentation at an advanced stage. Therefore, the current research aimed to understand the knowledge of breast cancer symptoms and risk factors among women in a low socio-economic area of Mumbai. METHODS: A cross-sectional study was conducted at Prabhadevi, Mumbai and primary data was collected from 480 women aged 18-55 years. Structured questionnaire was used to collect quantitative data pertaining to awareness, signs and symptoms of breast cancer. Bivariate and multivariate regression techniques were used for understanding of the socio-demographic differentials in breast cancer awareness among women. RESULTS: The study found that around half (49%) of the women were aware of breast cancer. The women who were aware of breast cancer considered lump in breast (75%), change in shape and size of breast (57%), lump under armpit (56%), pain in one breast (56%) as the important and common symptoms. Less than one-fifth of the women who were aware of breast cancer reported early menstruation (5.6%), late menopause (10%), hormone therapy (13%), late pregnancy (15%) and obesity (19%) as the risk factors for breast cancer. The multivariate regression analysis showed women who had more than 10 years of schooling (Adjusted Odds Ratio: 3.93, CI: 2.57-6.02, P < 0.01) were about 4 times more likely to be aware of breast cancer than women who had less than 10 years of schooling. CONCLUSION: In conclusion, knowledge of danger signs and risk factors of breast cancer were low among women in the community. This may lead to late detection of breast cancer among women in the community. Therefore, the study calls for advocacy and larger intervention to enhance knowledge of breast cancer among women in the particular region with a special reference to women with low education.

Vaginal microbiota of asymptomatic bacterial vaginosis and vulvovaginal candidiasis: Are they different from normal microbiota?

Vaginal microbiota contributes in maintaining and protecting the urogenital niche from infections and their sequelae. Despite extensive research, microbiome studies have often ignored asymptomatic bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). The present study aimed to explore the cultivable vaginal bacterial and mycological communities in women asymptomatic for BV and VVC using multiplex PCR and species-specific PCR. Vaginal swabs collected from 199 participants asymptomatic for urogenital infections, scored by Nugent criteria indicated 73.9% had normal microbiota, 11.6% intermediate and 14.5% BV. The most frequent Lactobacillus species in normal women were L. iners (69.4%), L. crispatus (24.5%), L. reuteri (20.4%). Women with BV colonized L. iners (62.1%); L. rhamnosus (41.4%); L. salivarius (13.7%) and L. reuteri (7.2%). Furthermore, L. crispatus was associated with normal microbiota, whereas L. iners was a frequent member of normal and dysbiotic microbiota. Lactobacillus abundance and species richness reduced in asymptomatic BV. Also L. crispatus, L. fermentum, L. acidophilus and L. delbruckii were absent in these women. L. iners significantly co-existed with other Lactobacillus species, indicating its failure in independently maintaining the healthy vaginal niche. Of 30.4% women detected with Candida, 72.1% constituted non-albicans Candida. Predominance of C. albicans increased from 18.4% in healthy to 60% in women with asymptomatic BV; whereas distribution of BV related bacteria did not vary across the groups. Heterogeneous population of lactobacilli in 80.8% of normal women calls attention towards cumulative effects of these species in safeguarding the vaginal microenvironment. Since the microbiota of asymptomatic BV was different from healthy, screening and management could be encouraged to avoid further complications of infections.

A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

BACKGROUND: Prior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage and counsel husbands on gender equity and family planning (GE + FP), was demonstrated by increased pill and condom use and a reduction in MSV. However, the intervention had limited reach to women and was therefore unable to expand access to highly effective long acting reversible contraceptives such as the intrauterine device (IUD). We developed a second iteration of the intervention, CHARM2, which retains the three sessions from the original CHARM but adds female provider- delivered counseling to women and offers a broader array of contraceptives including IUDs. This protocol describes the evaluation of CHARM2 in rural Maharashtra. METHODS: A two-arm cluster randomized controlled trial will evaluate CHARM2, a gender synchronized GE + FP intervention. Eligible married couples (n = 1200) will be enrolled across 20 clusters in rural Maharashtra, India. Health providers will be gender-matched to deliver two GE + FP sessions to the married couples in parallel, and then a final session will be delivered to the couple together. We will conduct surveys on demographics as well as GE and FP indicators at baseline, 9-month, and 18-month follow-ups with both men and women, and pregnancy tests at each time point from women. In-depth interviews will be conducted with a subsample of couples (n = 50) and providers (n = 20). We will conduct several implementation and monitoring activities for purposes of assuring fidelity to intervention design and quality of implementation, including recruitment and tracking logs, provider evaluation forms, session observation forms, and participant satisfaction surveys. DISCUSSION: We will complete the recruitment of participants and collection of baseline data by July 2019. Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03514914 .

Prognostic implications of histological tumor regression (Böhm's score) in patients receiving neoadjuvant chemotherapy for high grade serous tubal & ovarian carcinoma.

OBJECTIVE: Primary objective of this study was to determine prognostic significance of Bohm's histopathological regression score in patients who received neoadjuvant chemotherapy (NACT) for treatment of high grade serous (HGS) tubal & ovarian carcinoma. METHODS: This was a retrospective cohort study of patients who received NACT between 2010 and 2015. The 3 point histopathological regression score of Böhm was used to classify chemotherapy response. Survival outcomes between the 3 different subgroups was analysed and compared with standard clinico-pathological variables using the Cox proportional hazards model and log-rank test. RESULTS: Study cohort comprised 111 patients. Chemotherapy response score (CRS) 3 was observed in 47 (42.4%) and CRS 1and CRS 2 in 22 (19.8%) and 42 (37.8%) women respectively. Women with CRS score of 1 and 2 combined showed a three-fold increased risk of progression on both univariate and multivariate assessment (HR 3.54; C.I 2.19-5.72, p < 0.001). The median overall survival for patients with CRS 1 was 34 months, CRS 2 was 30 months and 47 months for CRS 3. CRS 1 and 2 combined was the only variable that held significance in prediction of reduced overall survival on multivariate assessment (HR 3.26, C.I 1.91-5.54, p 0.0006). CRS 1 and 2 were also associated with 5.15-fold increased risk of relapse within 6 months of completion of chemotherapy (Odds ratio OR 5.15, C.I 0.07-0.47, p - 0.002). CONCLUSION: CRS is an independent prognosticator of survival and reliable predictor of relapse within 6 months in advanced high grade serous tubal and ovarian carcinoma patients receiving NACT.

Do elevated symptoms of depression predict adherence and outcomes in the UPBEAT randomised controlled trial of a lifestyle intervention for obese pregnant women?

BACKGROUND: Lifestyle interventions for obese pregnant women have been widely researched but little is known about predictors of low adherence or poor outcomes. This study evaluated the prospective associations between elevated symptoms of antenatal depression and gestational diabetes, adherence and gestational weight gain in a large RCT of a behavioural intervention for obese pregnant women. The effect of the intervention on symptoms of depression at follow-up was also examined. METHODS: The UPBEAT RCT randomised 1555 obese pregnant women to receive a dietary and physical activity lifestyle intervention or standard care. Symptoms of antenatal depression were assessed with the Edinburgh Postnatal Depression Scale at baseline (15+ 0-18+ 6 weeks' gestation) and follow-up (27+ 0-28+ 6 weeks' gestation). Gestational diabetes was assessed with an oral glucose tolerance test at 27+ 0-28+ 6 weeks' gestation. Adherence was pre-defined as receiving at least 5 of 8 intervention sessions. Gestational weight gain was calculated as the difference between pre-pregnancy weight (estimated as measured baseline weight minus 1.25 kg) and last measured weight at 34+ 0-36+ 0 weeks' gestation. Due to substantial missing data in certain variables, multiple imputation was used to impute missing data. Women who were no longer pregnant at 27+ 0-28+ 6 weeks' gestation were excluded from the sample for these analyses. RESULTS: One thousand five-hundered twenty-six women were included in these analyses following multiple imputation; 797 (52.2%) had complete data. 13.4% had elevated symptoms of antenatal depression at baseline. There was no evidence for associations between antenatal depression status and gestational diabetes (adjusted OR 0.80, 95%CI 0.52 to 1.22, p = 0.30), adherence (adjusted OR 1.16, 95%CI 0.63 to 2.15, p = 0.63) or gestational weight gain (adjusted regression coefficient 0.52, 95%CI -0.26 to 1.29, p = 0.19). The intervention was not associated with change in depressive symptoms at follow-up (regression coefficient 0.003, 95%CI -0.49 to 0.49, p = 0.99). Similar results were obtained in complete case analyses. CONCLUSIONS: Elevated symptoms of antenatal depression did not predict gestational diabetes, adherence or gestational weight gain in this large RCT of a lifestyle intervention for obese pregnant women. The intervention also did not influence symptoms of depression at follow-up. Obese pregnant women with elevated symptoms of depression should not be excluded from lifestyle interventions. TRIAL REGISTRATION: ISRCTN89971375 . Registered 28 November 2008.

Therapeutic plasma exchange as a novel treatment for severe intrahepatic cholestasis of pregnancy: Case series and mechanism of action.

INTRODUCTION: Intrahepatic cholestasis of pregnancy is characterised by pruritus and elevated serum bile acids. The pruritus can be severe, and pharmacological options achieve inconsistent symptomatic improvement. Raised bile acids are linearly associated with adverse fetal outcomes, with existing management of limited benefit. We hypothesised that therapeutic plasma exchange removes pruritogens and lowers total bile acid concentrations, and improves symptoms and biochemical abnormalities in severe cases that have not responded to other treatments. METHODS: Four women with severe pruritus and hypercholanemia were managed with therapeutic plasma exchange. Serial blood biochemistry and visual analogue scores of itch severity were obtained. Blood and waste plasma samples were collected before and after exchange; individual bile acids and sulfated progesterone metabolites were measured with HPLC-MS, autotaxin activity and cytokine profiles with enzymatic methods. Results were analysed using segmental linear regression to describe longitudinal trends, and ratio t tests. RESULTS: Total bile acids and visual analogue itch scores demonstrated trends to transiently improve following plasma exchange, with temporary symptomatic benefit reported. Individual bile acids (excluding the drug ursodeoxycholic acid), and the sulfated metabolites of progesterone reduced following exchange (P = .03 and P = .04, respectively), whilst analysis of waste plasma demonstrated removal of autotaxin and cytokines. CONCLUSIONS: Therapeutic plasma exchange can lower potentially harmful bile acids and improve itch, likely secondary to the demonstrated removal of pruritogens. However, the limited current experience and potential complications, along with minimal sustained symptomatic benefit, restrict its current use to women with the most severe disease for whom other treatment options have been exhausted.