Demonstration project of oral TDF-containing PrEP, administered, once-daily orally to men having sex with men (MSM) and transgender women (TGW) in India: Study protocol.

BACKGROUND: India has successfully reduced Human Immuno-deficiency Virus (HIV) incidence, with a 66% decline since the year 2000 has been seen; however, control among Men having sex with Men (MSM) and transgender women (TGW) remains a critical challenge. Oral Pre-Exposure Prophylaxis (PrEP) may help close a critical HIV prevention gap for MSM and TGW in India; however, no studies to date have evaluated the feasibility of oral PrEP among MSM and TGW in India. METHODS: The proposed study aims at understanding the implementation of the provision of daily oral-Tenofovir (TDF) containing PrEP among MSM and TGW through the clinic and community-based delivery models in Pune, Maharashtra, and Jalandhar, Punjab respectively in India. The study aims at estimating PrEP adherence, facilitators, and barriers to PrEP use, retention, acceptability, and willingness to pay for PrEP. After the screening, eligible participants (n = 600) will receive PrEP medicines and will be monitored quarterly for HIV, STIs, and renal and liver toxicity for 12 months as per the schedule of events. The primary outcomes of interest are PrEP acceptability, PrEP adherence, retention rate, adverse medical events, and sexual behavioural changes with PrEP use and breakthrough infections while on PrEP. The study will assess the feasibility of two service delivery models; however, the data from the two service delivery models will be analyzed independently and will not be compared for feasibility and other outcome indicators. The study has been initiated after obtaining appropriate regulatory approvals. DISCUSSION: PrEP is efficacious in preventing HIV among high-risk population however there are scarce data on providing PrEP to MSM and TGW. The study will provide critical evidence to programs and policymakers on the implementation of PrEP in a "real world" setting, among MSM and TGW in India including identifying populations that can benefit most from this additional HIV prevention intervention along with acceptable delivery strategies and means of support for adherence. TRIAL REGISTRATION: Not applicable being a demonstration project. Efficacy is already proven.

Longitudinal Assessment of Calcium and Magnesium Levels in Women with Preeclampsia.

The present study reports the levels of maternal serum calcium and magnesium from early pregnancy until delivery, along with cord levels, in women who developed preeclampsia (PE) and compares them with those without PE. A total of 324 pregnant women (216 non-PE and 108 PE women) were included in this retrospective case-control study of prospectively collected data nested in an observational cohort study. Maternal blood was collected at 4 time points during pregnancy (V1 = 11-14 weeks, V2 = 18-22 weeks, V3 = 26-28 weeks, and V4 = at delivery) and umbilical cord blood at delivery. Independent t tests were used to compare calcium, magnesium, and their ratio between two groups, and their associations with PE were studied using regression models. Calcium levels were similar between groups at all time points. Magnesium levels were lower (p = 0.021) at V2 in PE group as compared with non-PE group. Maternal calcium and magnesium levels were negatively associated, with blood pressure in early pregnancy. In fully adjusted logistic regression analysis, lower magnesium levels were associated with an increased risk of PE at V2 (OR 0.25 [95% CI 0.07, 0.94] p = 0.04). Lower magnesium in mid-pregnancy was associated with higher risk of PE. These changes were observed before the diagnosis of PE, thereby suggesting that they may have a role in the etiology of PE.

Evaluation of implantation markers and immune cell infiltration in endometrial biopsy of female genital tuberculosis.

BACKGROUND: Female genital tuberculosis (FGTB) causes infertility in a significant number of females. The immunological impact of tuberculosis on endometrium in infertile females has not been studied before. The present study was designed to evaluate markers related to infiltrating immune cells and implantation in endometrial aspiration from infertile females and correlate with conventional tests and polymerase chain reaction (PCR) for tuberculosis (TB). METHODS: It was a prospective cohort study with 385 patients out of which IHC was done in 306 over a period of 3 years from 2013 to 2016 in a tertiary care hospital. Women with infertility, 20-35 years of age, without history of pulmonary TB or intake of antitubercular therapy were included. Endometrial samples were subjected to PCR for TB along with microbiological and histological examination for TB. Immunohistochemistry for CD45, CD3, CD20, CD4, CD8, CD68, CD138, Interferon gamma, Interleukin 10 (IL-10) and implantation markers MUC1 and Notch 1 were done on the endometrial samples along with 25 control subjects. RESULTS: Conventional tests for tuberculosis like staining for acid fast bacilli (AFB), granuloma on histology or culture positivity were seen in 2.61% (6/306; 1.96% had granulomas, 1/306; 0.32% was AFB positive, 2/306; 0.6% were liquid culture positive). PCR was positive in 190/306 (62.09%). CD3, CD20, CD45, CD68, CD4, CD8 and CD 138 expressing infiltrating cells were not significantly related to PCR positive cases. Interferon gamma expressing lymphocytes were significantly higher (38.94%) in PCR positive endometria compared to 26.72% in the PCR negative (p = 0.04). Notch -1 expression correlated significantly with the occurrence of pregnancy. A trend towards high intensity expression of Notch1 was seen in PCR negative cases. MUC-1 expression did not correlate with pregnancy although interferon gamma expression was significantly related to low intensity MUC1 expression. CONCLUSIONS: Immunohistochemical markers are not reliable tests in diagnosis of FGTB. Notch 1 expression though showing correlation with pregnancy has to be further evaluated with a panel of other implantation markers. STUDY FUNDING: Indian Council of Medical Research, New Delhi, India.

Gestational weight gain in the REVAMP pregnancy cohort in Western India: Comparison with international and national references.

Objective: To determine the trimester specific gestational weight gain (GWG) in a population of pregnant women from Western India and compare it with the Intergrowth-21st international and an Indian reference (GARBH-Ini cohort-Group for Advanced Research on BirtH outcomes). Study design: A prospective longitudinal observational study was undertaken in Pune, West India and data for gestational weight gain was collected [the REVAMP study (Research Exploring Various Aspects and Mechanisms in Preeclampsia)]. Generalized Additive Models for Location, Scale and Shape method (GAMLSS model) were used to create GWG centile curves according to gestational age, stratified by BMI at recruitment (n = 640) and compared with Intergrowth-21st reference and GARBH-Ini cohort. Multivariable regression analysis was used to evaluate the relationship between GWG and antenatal risk factors. Results: The median GWG was 1.68, 5.80, 7.06, and 11.56 kg at gestational ages 18, 26, 30, and 40 weeks, respectively. In our study, pregnant women gained less weight throughout pregnancy compared to Intergrowth-21st study, but more weight compared to the GARBH-Ini cohort centile curves in all the BMI categories. GWG in overweight/obese women (BMI ≥ 25) was significantly lower (<0.001) as compared to underweight (BMI < 18.5), or normal weight women (BMI ≥ 18.5 and <25). The median GWG at 40 weeks in underweight, normal and overweight/obese women was 13.18, 11.74, and 10.48 kg, respectively. Higher maternal BMI, older maternal age, higher parity and higher hemoglobin concentrations were associated with lower GWG, while taller maternal height was associated with greater GWG. Conclusion: GWG of Indian women is lower than the prescriptive standards of the Intergrowth charts.

Kaposi sarcoma (KS) with primary effusion lymphoma in HIV infected MSM (men having sex with men) co-infected with pulmonary tuberculosis and syphilis: a case report from India.

We describe a case of a 30-year-old MSM recently diagnosed with HIV, immunocompromised with a purplish or brown rash all over the body for 3 to 4 months. The histopathology of the cutaneous lesions and pleural effusion aspirate confirmed the diagnosis of Kaposi's sarcoma (KS) and primary effusion lymphoma (PEL). While KS is one of the AIDS-defining illnesses seen in immunocompromised patients having low CD4 count, PEL is a rare and distinct subset of AIDS-related lymphoma. Despite the widespread availability of HIV testing, HIV diagnosis gets delayed due to stigma among MSM. This case report emphasizes the importance of early suspicion for symptoms of HIV-associated opportunistic infections in high-risk populations like MSM. The report reiterates the need for an ambient stigma-free environment for improving HIV screening in this high-risk population.

Immunohistochemical evaluation of infiltrating immune cells in endometrial biopsy of female genital tuberculosis.

BACKGROUND: Female Genital Tuberculosis (FGTB) causes infertility in a large number of females in developing countries. Presence of granuloma on histopathological examination of endometrial samples is diagnostic of FGTB. But immunohistochemical evaluation of endometrial aspirates has not been explored before. AIM: To evaluate the immunohistochemical delineation of immune cells in FGTB. METHODS: 1515 infertile women from 20 to 35 years were enrolled and underwent endometrial aspiration (EA), which was subjected to microbiological and histopathological examination along with PCR. Patients positive for conventional tests like granulomas, acid fast bacilli, mycobacterial culture on LJ medium or liquid (MGIT) culture were started on antitubercular therapy. Conventional test negative but PCR positive patients were posted for laparoscopy. Immunohistochemistry (IHC) for LCA, CD68, CD3, CD4, CD8, CD 20, CD138, IFN gamma and IL10 were evaluated. RESULT: 38/1515 (2.5%) subjects tested positive for conventional methods. PCR-TB was positive in 615/1515 samples (40.59%). On IHC, the number of CD45 (LCA) positive immune cells (p = 0.03) and IFN gamma (p = 0.002) and IL10 expression (p = 0.012) at 1 + level were higher in the PCR positive samples. Laparoscopy done in 418/463 patients and 89/418 (21.3%) showed definitive findings of tuberculosis. CD3, CD4, CD8, CD20, CD68 and CD138 showed no correlation with PCR and laparoscopy. CONCLUSION: Increased IFN gamma and IL 10 expressing immune cells in PCR positive EA suggests subclinical early changes, and can be useful as a research tool but have no role in diagnosing FGTB.

Understanding issues around use of oral pre exposure prophylaxis among female sex workers in India.

BACKGROUND: Empowering female sex workers (FSWs) through women controlled HIV prevention option has been in focus globally. FSWs are important target for oral pre exposure prophylaxis (PrEP). A multi-centric qualitative study was conducted to explore the FSWs' willingness to use oral PrEP in India. METHODS: Seventy three interviews and 02 focus group discussions were conducted at 3 high HIV prevalent states in India during 2013-14. Study explored issues around willingness to use oral PrEP. The study was approved by the respective institutional ethics committee of the study sites. Thematic analysis using grounded theory approach was used to analyze the data in N-VIVO version 8.0. RESULTS: Thematic analysis showed events of forced condom-less sex. FSWs believed that oral PrEP could provide independence, financial gains, and privacy and therefore hoped to use it as an alternative to male condom. However, any impact on physical/ aesthetic attributes and reproductive system were not acceptable and could become a barrier. Provider initiated oral PrEP was not preferred. Providers voiced safety monitoring concerns. Adherence emerged as a challenge because of: (1) alcohol use; (2) taking PrEP tablet each day being boring; (3) Stigma because Oral PrEP is ARV based. Alcohol use and dread of repetitive dose brings forth the need for long acting oral PrEP. CONCLUSION: Oral PrEP is acceptable among FSWs; it should be rolled out alongside strong messages on STI protection and PrEP as compliment to condoms. PrEP roll out requires educating communities about HIV treatment versus prevention. Long-acting oral PrEP could address both 'boredom' and alcoholism and sustain adherence.

Barriers to optimal and appropriate use of uterotonics during active labour and for prevention of postpartum haemorrhage in public health care facilities: An exploratory study in five states of India.

OBJECTIVE: The main objective is to understand the practices regarding use of uterotonics during active labour and for prevention of postpartum haemorrhage and the barriers for its optimal and appropriate use at different levels of health facilities in five states of India. STUDY DESIGN: Mixed methods approach comprising of cross-sectional observational study of existing practices of uterotonics use during labour and early postpartum period for 1479 vaginal deliveries at 56 facilities. Quantitative data was collected using pre-tested proformas filled by on-site observers and qualitative data was collected by in-depth interviews of 125 maternity care providers of the observed facilities. MAIN OUTCOME MEASURE: Providers' knowledge, attitude and patterns of use of uterotonics during active labour and for prevention of postpartum haemorrhage during childbirth. RESULTS: On-site observation and interviews indicated inappropriate choice of uterotonics administered in varied doses for labour management across facilities. Unnecessary augmentation of labour was observed in 44.7% low-risk pregnancies and only 31% women were administered uterotonics in optimal doses for preventing postpartum haemorrhage. Only 46.4% providers in the observed facilities reported to have received maternal and child healthcare training according to the updated guidelines. Lack of supportive supervision for mandated practices among peers emerged as an important barrier for appropriate uterotonics usage in labour. CONCLUSION: There is an urgent scope of standardizing the institutional health policies regarding administration of uterotonics during labour and for prevention of postpartum haemorrhage. Capacity building of maternity care providers regarding appropriate uterotonics usage is recommended for all levels of health facilities.

Placental neurotrophin levels in gestational diabetes mellitus.

OBJECTIVE: Neurotrophins are known to influence the development and maturation of the feto-placental unit and affect fetal growth trajectories. This study reports the levels of nerve growth factor (NGF) and brain-derived growth factor (BDNF) in the placenta of women with gestational diabetes mellitus (GDM). METHODS: A total number of 60 women with GDM and 70 women without GDM (non-GDM) were included in the study. Placental NGF and BDNF levels were measured using commercially available ELISA kits. RESULTS: Placental NGF levels were lower (p < .05) in women with GDM compared to non-GDM women. Maternal body mass index (BMI), mode of delivery, and the gender of the baby influenced the placental NGF levels. Placental BDNF levels were similar in GDM and non-GDM women. There was an influence of baby gender on the placental BDNF levels while maternal BMI and mode of delivery did not show any effect. In regression models adjusted for maternal age at delivery, gestational age, maternal BMI, mode of delivery, and baby gender, the placental NGF levels in the GDM group were lower (-0.144 pg/ml [95% CI -0.273, 22120.016] p = .028) as compared to the non-GDM group. However, there was no difference in the BDNF levels between the groups. CONCLUSION: This study for the first time demonstrates differential effects on neurotrophic factors such as BDNF and NGF in the placenta in pregnancies complicated by GDM. Alterations in the levels of placental neurotrophins in GDM deliveries may affect placental development and fetal brain growth. This has implications for increased risk for neurodevelopmental pathologies in later life.

Role of Laparoscopy in the Diagnosis of Genital TB in Infertile Females in the Era of Molecular Tests.

STUDY OBJECTIVE: To assess diagnostic value of polymerase chain reaction (PCR) in endometrial aspirates (EAs) in comparison with conventional tests for diagnosis of female genital tuberculosis (TB) and to find agreement between EA PCR done for endometrial TB and laparoscopic findings of pelvic TB in women with unexplained infertility. DESIGN: Prospective observational cohort study. SETTING: Tertiary care hospital. PATIENTS: A total of 732 infertile females screened and 385 enrolled to undergo procedure to obtain EAs. INTERVENTIONS: EAs were tested by conventional tests (histopathology, acid-fast bacilli, Lowenstein-Jensen staining, liquid culture) and PCR for Mycobacterium tuberculosis. Patients with positive conventional tests were started on antitubercular treatment (ATT). Patients with negative conventional tests underwent laparohysteroscopy irrespective of PCR results to assess changes of tubercular infection in the pelvis. Peritoneal washings were also sent for liquid culture and PCR for TB, and suspicious lesions were biopsied at laparohysteroscopy. Findings at laparoscopy upgraded the diagnosis in these women. EAPCR results were analyzed to find agreement with the findings at laparoscopy. MEASUREMENTS AND MAIN RESULTS: Conventional tests were positive in 8 of 385 (2%) patients. PCR was positive in 58.1% (n = 224) of endometrial samples, with sensitivity of 62.5% (95% confidence interval [CI], 24.49-91.48), specificity of 41.91% (95% CI, 36.88-47.07), positive predictive value of 2.23% (95% CI, 1.31-3.78), negative predictive value of 98.14% (95% CI, 95.53-99.24), and a diagnostic accuracy of 42.34% (95% CI, 37.35-47.45) with conventional tests. A total of 265 patients underwent laparoscopy, of whom 165 were PCR positive and 100 were PCR negative. Laparoscopic findings suggestive of TB were found in 39.3% of patients who were PCR positive and 9% of patients who were PCR negative. Kappa agreement was 0.25, suggesting fair agreement between PCR and laparoscopy. CONCLUSION: PCR as a stand-alone diagnostic test for endometrial TB is not justified to confirm diagnosis and initiate ATT. The addition of laparohysteroscopy improves diagnostic yield for genital TB. Referring patients with a suspicion of female genital TB to tertiary care for 1-time laparoscopy is better than initiating ATT solely on the basis of PCR results.

The Cost-effectiveness of Human Immunodeficiency Virus (HIV) Preexposure Prophylaxis and HIV Testing Strategies in High-risk Groups in India.

BACKGROUND: The human immunodeficiency virus (HIV) epidemic in India is concentrated among 3.1 million men who have sex with men (MSM) and 1.1 million people who inject drugs (PWID), with a mean incidence of 0.9-1.4 per 100 person-years. We examined the cost-effectiveness of both preexposure prophylaxis (PrEP) and HIV testing strategies for MSM and PWID in India. METHODS: We populated an HIV microsimulation model with India-specific data and projected clinical and economic outcomes of 7 strategies for MSM/PWID, including status quo; a 1-time HIV test; routine HIV testing every 3, 6, or 12 months; and PrEP with HIV testing every 3 or 6 months. We used a willingness-to-pay threshold of US$1950, the 2017 Indian per capita gross domestic product, to define cost-effectiveness. RESULTS: HIV testing alone increased life expectancy by 0.07-0.30 years in MSM; PrEP added approximately 0.90 life-years to status quo. Results were similar in PWID. PrEP with 6-month testing was cost-effective for both MSM (incremental cost-effectiveness ratio [ICER], $1000/year of life saved [YLS]) and PWID (ICER, $500/YLS). Results were most sensitive to HIV incidence. PrEP with 6-month testing would increase HIV-related expenditures by US$708 million (MSM) and US$218 million (PWID) over 5 years compared to status quo. CONCLUSIONS: While the World Health Organization recommends PrEP with quarterly HIV testing, our analysis identifies PrEP with semiannual testing as the cost-effective HIV prevention strategy for Indian MSM and PWID. Since nationwide scale-up would require a substantial fiscal investment, areas of highest HIV incidence may be the appropriate initial targets for PrEP scale-up.

The REVAMP study: research exploring various aspects and mechanisms in preeclampsia: study protocol.

BACKGROUND: Preeclampsia is a major cause of maternal, fetal and neonatal morbidity and mortality, particularly in developing countries. Considering the burden of preeclampsia and its associated complications, it is important to understand the underlying risk factors and mechanisms involved in its etiology. There is considerable interest in the potential for dietary long chain polyunsaturated fatty acids (LCPUFA) as a therapeutic intervention to prevent preeclampsia, as they are involved in angiogenesis, oxidative stress, and inflammatory pathways. METHODS: The REVAMP study (Research Exploring Various Aspects and Mechanisms in Preeclampsia) follows a cohort of pregnant women from early pregnancy until delivery to examine longitudinally the associations of maternal LCPUFA with clinical outcome in preeclampsia. A multisite centre for advanced research was established and pregnant women coming to Bharati hospital and Gupte hospital, Pune, India for their first antenatal visit are recruited and followed up at 11-14 weeks, 18-22 weeks, 26-28 weeks, and at delivery. Their personal, obstetric, clinical, and family history are recorded. Anthropometric measures (height, weight), food frequency questionnaire (FFQ), physical activity, socioeconomic status, fetal ultrasonography, and color Doppler measures are recorded at different time points across gestation. Maternal blood at all time points, cord blood, and placenta at delivery are collected, processed and stored at - 80 °C. The children's anthropometry is assessed serially up to the age of 2 years, when their neurodevelopmental scores will be assessed. DISCUSSION: This study will help in early identification of pregnant women who are at risk of developing preeclampsia. The prospective design of the study for the first time will establish the role of LCPUFA in understanding the underlying biochemical and molecular mechanisms involved in preeclampsia and their association with developmental programming in children.

Use of histograms to assess the efficacy of uterotonic treatment for post-partum haemorrhage: A feasibility study.

Post-partum haemorrhage (PPH) is a major pathological condition leading to mortality of women worldwide. Its initial treatment has largely been focused on uterotonics. This paper examines the use of histograms to assess the efficacy of uterotonic treatment for PPH. Previous examinations of large datasets in which women were treated at 700 ml of measured blood loss according to strict protocols have shown a quantifiable peak in the histogram at 700-800 ml following treatment. It is not clear whether this is commonly seen in other studies. The main aim was therefore to assess whether post-treatment peaks are routinely seen in postpartum blood loss histograms and whether the peaks are seen only in treated women. Four datasets of more than 1000 women with measured blood loss were identified and the original data examined. The secondary peak was not only seen in histograms attributed to treatment, but also many of the histograms where women had not received uterotonic treatment. Many women received treatment despite having blood loss of less than 500 ml, and many women who stopped bleeding with final blood losses of more than 500 ml did not receive any uterotonics. The routine use of histogram analysis to assess the efficiency of uterotonic therapy is not recommended. The paper also provides further insights into clinical practice, with clinicians frequently using uterotonic therapies even when the volume of the blood loss is low. This demonstrates how uterotonic use in practice is often not linked to the standard 500 ml definition of post-partum haemorrhage.

Labour & delivery monitoring patterns in facility births across five districts of India: A cross-sectional observational study.

BACKGROUND & OBJECTIVES: India has recorded a marked increase in facility births due to government's conditional cash benefit scheme initiated in 2005. However, concerns have been raised regarding the need for improvement in the quality of care at facilities. Here we report the monitoring patterns during labour and delivery documented by direct observation in reference to the government's evidence-based guidelines on skilled birth attendance in five districts of India. METHODS: A cross-sectional study design with multistage sampling was used for observation of labour and delivery processes of low-risk women with singleton pregnancy in five districts of the country. Trained research staff recorded the findings on pre-tested case record sheets. RESULTS: A total of 1479 women were observed during active first stage of labour and delivery in 55 facilities. The overall frequency of monitoring of temperature, pulse and blood pressure was low at all facilities. The frequency of monitoring uterine contractions and foetal heart sounds was less than the expected norm, while the frequency of vaginal examinations was high at all levels of facilities. Partograph plotting was done in only 15.8 per cent deliveries, and labour was augmented in about half of the cases. INTERPRETATION & CONCLUSIONS: The findings of our study point towards a need for improvement in monitoring of maternal and foetal parameters during labour and delivery in facility births and to improve adherence to government guidelines for skilled birth attendance.

Knowledge and Skills of Ayurvedic and Homeopathic Practitioners to Provide Skilled Birth Attendance in India: An Observational Study.

BACKGROUND: To overcome the dearth of trained skilled birth attendants, mainstreaming of doctors from the alternative systems of medicine has been adopted by some states in India. OBJECTIVES: The objectives of the study were to explore the adequacy of knowledge and clinical skills of AYUSH practitioners (APs) (ayurvedic and homeopathic) engaged by the state governments to provide maternity care services, with a view to identify gaps if any, and to suggest measures for improvement. MATERIALS AND METHODS: A cross-sectional observational study was conducted in three states of India (Maharashtra, Rajasthan, and Odisha). The APs were assessed for (a) knowledge of essential obstetric care and identification and management of complications of pregnancy and (b) clinical skills during provision of antenatal and postnatal care (PNC) and during the conduct of deliveries. Adequate knowledge or skill demonstration was defined as a score of 70% or more. RESULTS: A total of 109 APs engaged in 37 peripheral level facilities were assessed. Nearly 76% of APs had adequate theoretical knowledge of essential obstetric care and identification and management of complications of pregnancy. Most APs demonstrated adequate skills while providing antenatal care but were deficient in taking past history and counseling pregnant women for danger signs during pregnancy and childbirth. APs in Maharashtra and Rajasthan had adequate skills for conducting vaginal deliveries but performed poorly in Odisha. Skills for resuscitation of newborn were deficient. Skills for providing PNC were adequate only among APs in Maharashtra. CONCLUSION: Through provision of appropriate in-service training and an enabling environment, APs may be a useful human resource for providing maternity care in the primary health-care settings in India.

Perceptions and experiences of women seeking treatment for obstetric fistula.

OBJECTIVE: To understand patients' perspectives on the causative factors and preventive measures of obstetric fistula; and the effect of fistula on the victims' psycho-social, sexual, and economic well being. METHODS: A questionnaire-based interview of 215 women with obstetric fistula admitted for treatment in 17 hospitals in India was carried out during 2010-2011. Responses of participants from poor, medium, and better performing states were categorized into pre-coded themes and compared. RESULTS: The majority of the women were from rural areas (75.3%), multiparous (68.8%), and with less than high school education (82.2%). The majority (70.7%) of the women reported attempt at home delivery by untrained persons. Poor awareness of where and when to seek care when faced with a difficult delivery, and poor quality of care in facilities were perceived as important causative factors. Delivery by trained providers and early referral of women with problems during labor were identified as important preventive factors. Spouses and families were supportive of treatment in spite of economic hardships, but most (79.5%) patients felt socially isolated after developing fistula. CONCLUSION: Poor awareness regarding delivery care among the women indicates a need for increasing birth preparedness in the community. Patients' perceptions of poor quality of care in facilities need to be addressed urgently. Psychological evaluation and counseling should be offered to fistula patients, to help them cope with adverse psycho-social and economic circumstances. The results of this study may provide insights for prevention and management of fistula, and may help to improve patient care and services.

Weekly iron folic acid supplementation plays differential role in maintaining iron markers level in non-anaemic and anaemic primigravida: A randomized controlled study.

Anaemia during pregnancy is most commonly observed and highly prevalent in South-East Asia. Various effective programmes have been laid down for its management, mainly daily supplementation of iron folic acid (IFA) tablets. Following the same, standard obstetrical practice has included the IFA supplementation without requiring the determination of iron deficiency. In this study, a total of 120 primigravida (N = 60; non-anaemic (Hb > 11 g/dl) and N = 60 anaemic (Hb = 8-11 g/dl)) were selected among those attending the Antenatal Clinic in Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India. They were supplemented with daily and weekly IFA tablets till 6 weeks postpartum. Corresponding changes in haemoglobin level on advance of pregnancy, side effects and compliance associated with daily and weekly IFA supplementation and its associations with iron status markers were studied. The inflammatory markers were also estimated. The statistical significance level (p < 0.05) between the groups were assessed by applying unpaired t-test using SPSS (version 16.0). The obtained results publicized the salutary role of daily IFA supplementation in improving the haemoglobin level and iron status markers in anaemic pregnant women though the levels could not reach up to the non-anaemic haemoglobin levels. However, weekly IFA supplementation seems to be a better approach in non-anaemic pregnant women where almost comparable results were obtained in terms of haematological parameters, gestation length and birth weight. CONCLUSION: Weekly IFA supplementation found to be as effective as daily supplementation in iron sufficient non-anaemic pregnant women whereas anaemic pregnant women should be prescribed daily IFA supplementation irrespective of iron replete/deplete state.

Pattern of episiotomy use & its immediate complications among vaginal deliveries in 18 tertiary care hospitals in India.

BACKGROUND & OBJECTIVES: In developed countries, efforts have been made to restrict episiotomy practice. However, in developing countries the episiotomy rates continue to be high. This study was conducted to evaluate the pattern of episiotomy use and its immediate complications among women delivering at tertiary level public hospitals in India. METHODS: Prospective data of all women undergoing vaginal delivery including instrumental delivery were collected daily from the labour room registers of the 18 tertiary care hospitals on a structured proforma. Weekly data from all sites were sent to a central unit for compilation and analysis. Odds ratio was used to compare the proportion of genital trauma among women with and without episiotomy both in nulliparous and multiparous women. RESULTS: Among 1,20,243 vaginal deliveries, episiotomy was performed in 63.4 per cent (n=76,305) cases. Nulliparaous women were 8.8 times more likely to undergo episiotomy than multiparous women. The various genital tract injuries reported were first degree perineal tear (n=4805, 3.9%), second degree perineal tear (n=1082, 0.9%), third and fourth degree perineal tear (n=186, 0.2%), anterior vaginal trauma requiring suturing (n=490, 0.4%), extension of episiotomy/vaginal laceration/excessive bleeding from episiotomy or tear (n=177, 0.15%), vulval/vaginal haematoma (n=70, 0.06%) and cervical tear (n=108, 0.08%). The combined rate of third and fourth degree perineal tears was observed to be significantly lower (p<0.001) among nullipara who received episiotomy (0.13%) compared to those who delivered without episiotomy (0.62%). INTERPRETATIONS & CONCLUSIONS: Significantly lower rates of third or fourth degree perineal tear were seen among nulliparous women undergoing episiotomy. The risk and benefit of episiotomy and its complications need to be evaluated through randomized clinical trials in the Indian context.