Predictors for antenatal services and pregnancy outcome in a rural area: A prospective study in Wardha district, India.

Background :Antenatal care is essential to reduce morbidity and mortality among newborn babies and pregnant women. Aims: To study the pattern of utilization of antenatal services and to find out the potential predictors, their distributions and their association with antenatal care utilization and pregnancy outcomes. Settings and Design :A prospective longitudinal study was conducted in Deoli, a rural teaching area of a medical college of Wardha district, Maharashtra state. Materials and Methods : Medical social workers contacted all the registered 305 pregnant women in 1 month. A total of 274 women were included in the study. The response rate was 89.83%. Statistical Analysis Used : Percentages, rate ratio. Results : Mean age at marriage was 19.8±3.6 years, and the average age at first pregnancy was 21.6± 4.5 years. Of the 274 pregnant women, 156 (56.9%) were pregnant for the first time (gravida 1), and the remaining 118 (43.1%) pregnant women, gravida 2 and above, had an average of 2.1 living sons and 1.9 living daughters. Only 92 (33.6%) women had undergone the minimum recommended antenatal checkup during their current pregnancy, and 188 (68.6%) women had institutional deliveries. A large proportion of women in Deoli do not receive proper health care during pregnancy and childbirth. Conclusion : In Deoli, antenatal services, in spite of being essential to the care of pregnant women, are being poorly delivered.

Prevalence and pattern of childhood morbidity in a tribal area of Maharastra.

Previous studies have demonstrated that tribal children suffer from a higher rate of morbidity. Gender discrimination in the form of dietary neglect of the female children has also been noted. The community based cross-sectional study was carried out in tribal PHC Salona of Chikhaldara Block, Amaravati District, Maharashtra to study the prevalence and pattern of morbidities in children. 2603 study children between 0-72 months of age were covered in a house to house survey by the investigator. Parents of eligible children were interviewed using a pre-tested questionnaire for socio-demographic details, personal habits, past and current medical history. The prevalence of overall morbidities was 34.7% and it was higher in female as compared to male children (34.8% vs. 29.7%; chi2 = 9.3, p <0.005). Among individual morbidities, the prevalence of acute respiratory infections was the highest (25.5%) followed by acute diarrhoeal diseases (5.8%), conjunctivitis (1.5%), and skin infections (1.2%).

Prevalence and some epidemiological factors of beta thalassaemia trait in Sindhi community of Nagpur City, India.

OBJECTIVE: To study the prevalence of Beta thalassaemia trait (bTT) in Sindhi community of Nagpur City and to study association between bTT and some epidemiological factors like age at menarche in females, past history of diagnosis and treatment of anaemia and the current haemoglobin concentration. METHODS: The present cross-sectional study was undertaken among 446, young, apparently healthy, unrelated (by blood) Sindhi individuals before marriage or before reproduction. Blood samples were processed for Beta thalassaemia trait (bTT) using two stage approaches. Two screening tests namely Naked Eye Single Tube Red Cell Osmotic Fragility Test (NESTROFT) and RBC indices including Mean Corpuscular Volume (MCV) were performed on all samples and those positive for either one or both screening tests were further investigated for HbA2 level estimation by Haemoglobin electrophoresis on Cellulose acetate paper. HbA2 level of > 4.5% was taken as confirmatory of bTT. RESULTS: The prevalence of bTT in Sindhis of Nagpur was found to be 16.81%. No significant association was found between bTT & a delayed age at menarche, however a significantly higher number of trait carrier females had past history of diagnosis and treatment of anaemia while a significantly higher number of both male and female trait carriers had current haemoglobin concentration in anaemic range. CONCLUSION: The present study confirmed high prevalence of bTT in Sindhis.

Immunogenicity and safety of Abhay M and M-vac vaccines in healthy infants: a phase III multicentric randomized single blind trial.

OBJECTIVE: To study immunogenicity and safety of Abhay M and M-Vac vaccines in prevention of measles in healthy infants. METHODS: In a randomized, single blind, comparative, multi-centric phase III trial, a total of 600 healthy infants between 9 - 15 months of age were recruited in the study from seven participating sites during five months. The block randomization design was used for randomizing the subjects into 2 vaccine groups (Investigational Vaccine - Abhay M and Control Vaccine - M-Vac) in the ratio 2:1. At base line (visit 1) a venous blood sample 1.5 ml was collected and subjects were then administered a single dose 0.5 ml of measles vaccine (Abhay M or M-Vac vaccine) subcutaneously according to randomization. Following administration of vaccine, subjects were observed closely for 30 - 60 minutes at the study hospitals for local reactions and systemic events. At visit 2 (follow up visit) another venous blood sample 1.5 ml was collected and the paired sera (both pre and post vaccination serum) were tested concurrently. Safety and immunogenicity were assessed through follow-up of adverse events and anti measles antibody response respectively. RESULTS: Overall 95.7 % seroconversion was achieved in both the groups, 96% in Abhay M vaccine group and 95.1%. in M-Vac vaccine group. There were no statistically significant differences in the observed seroconversion rates. In Abhay M vaccine group, the pre vaccination geometric mean titers (GMT) significantly increased from 35.5 mIU/ml to 486.9 mIU/ml after vaccination. The observed significant increase of GMT in M-Vac vaccine group was from 33.3 mIU/ml to 375.8 mIU/ml. Overall 459 (82.5%) out of 556 subjects were seroprotected after vaccination i.e. > or equal to [corrected] 200 mIU/ml (Protective levels). Of the 459 seroprotected, 315 (84.9%) subjects were in Abhay M vaccine group and 144 (77.8%) subjects were in M-Vac vaccine group. The frequencies of the reported local and general symptoms were similar between the Abhay M vaccine group and M-Vac vaccine group. CONCLUSION: Human Biologicals Institute's Abhay M vaccine is equally immunogenic and as safe as M-Vac vaccine when administered to healthy infants in single dose schedule.

Cirumstances and motivations for seeking abortions: a community based study in Chandrapur District, Maharashtra.

The present population based group comparison study was undertaken to study the circumstances, motivations and influencing factors for seeking abortion in women in Chandrapur District of Maharashtra. Participants of the study included 500 cases of induced abortion and the equal number of normal delivered women during the same period and in the same area as comparison group. Having two children, domestic problems and unwanted pregnancy were conditions acceptable to study subjects to terminate the pregnancy. Family and domestic problems, poor socio-economic status, short inter-pregnancy interval and completed family size were some of the important reasons quoted by study subjects for not desiring to continue the current pregnancy. Majority of the subjects felt that the decision to terminate or keep pregnancy is usually taken jointly by both the husband and wife. Family and domestic problems, poor socioeconomic status and short inter pregnancy interval were the important reasons quoted by abortion cases for seeking abortion in the current pregnancy. Only 1.80% of the cases reported failure of contraceptive method as a cause of seeking abortion services. In 78.4% of abortion cases as compared to 5.4% subjects from the comparison group, pregnancy was un-planned.

A risk scoring system for prediction of haemorrhagic stroke.

The present pair-matched case control study was carried out at Government Medical College Hospital, Nagpur, India, a tertiary care hospital with the objective to devise and validate a risk scoring system for prediction of hemorrhagic stroke. The study consisted of 166 hospitalized CT scan proved cases of hemorrhagic stroke (ICD 9, 431-432), and a age and sex matched control per case. The controls were selected from patients who attended the study hospital for conditions other than stroke. On conditional multiple logistic regression five risk factors- hypertension (OR = 1.9. 95% Cl = 1.5-2.5). raised scrum total cholesterol (OR = 2.3, 95% Cl = 1.1-4.9). use of anticoagulants and antiplatelet agents (OR = 3.4, 95% Cl =1.1-10.4). past history of transient ischaemic attack (OR = 8.4, 95% Cl = 2.1- 33.6) and alcohol intake (OR = 2.1, 95% Cl = 1.3-3.6) were significant. These factors were ascribed statistical weights (based on regression coefficients) of 6, 8, 12, 21 and 8 respectively. The nonsignificant factors (diabetes mellitus, physical inactivity, obesity, smoking, type A personality, history of claudication, family history of stroke, history of cardiac diseases and oral contraceptive use in females) were not included in the development of scoring system. ROC curve suggested a total score of 21 to be the best cut-off for predicting haemorrhag stroke. At this cut-off the sensitivity, specificity, positive predictivity and Cohen's kappa were 0.74, 0.74, 0.74 and 0.48 respectively. The overall predictive accuracy of this additive risk scoring system (area under ROC curve by Wilcoxon statistic) was 0.79 (95% Cl = 0.73-0.84). Thus to conclude, if substantiated by further validation, this scorincy system can be used to predict haemorrhagic stroke, thereby helping to devise effective risk factor intervention strategy.

The BCG controversy: a reappraisal of the protective effect against tuberculosis and leprosy.

BCG (Bacillus Calmette Guerin) vaccine remains a highly controversial method of preventing tuberculosis and leprosy despite more than eighty years of use. The protective effect against tuberculosis observed in various studies ranged from -56% to 98%. Case-control studies carried out at Nagpur reported moderate effectiveness of BCG vaccination in prevention of tuberculosis. Its effectiveness was higher against extra-pulmonary tuberculosis. The summary protective effects obtained from meta-analysis of trials, cohort studies and case-control studies of BCG vaccination and tuberculosis were 51 (33-64), 76 (63-85), and 65 (57-72) percent respectively. The case-control studies carried out at Nagpur also demonstrated a significant protective association between BCG vaccination and leprosy. The summary protective effects obtained from meta-analysis of trials, cohort studies and case-control studies of BCG vaccination and leprosy were 43 (27-55), 62 (53-69), and 59 (46-68) percent respectively. The results of the current study and systematic review thus supported arguments favoring use of BCG vaccine for prevention of tuberculosis and leprosy.

Sample size and power analysis in medical research.

Among the questions that a researcher should ask when planning a study is "How large a sample do I need?" If the sample size is too small, even a well conducted study may fail to answer its research question, may fail to detect important effects or associations, or may estimate those effects or associations too imprecisely. Similarly, if the sample size is too large, the study will be more difficult and costly, and may even lead to a loss in accuracy. Hence, optimum sample size is an essential component of any research. When the estimated sample size can not be included in a study, post-hoc power analysis should be carried out. Approaches for estimating sample size and performing power analysis depend primarily on the study design and the main outcome measure of the study. There are distinct approaches for calculating sample size for different study designs and different outcome measures. Additionally, there are also different procedures for calculating sample size for two approaches of drawing statistical inference from the study results, i.e. confidence interval approach and test of significance approach. This article describes some commonly used terms, which need to be specified for a formal sample size calculation. Examples for four procedures (use of formulae, readymade tables, nomograms, and computer software), which are conventionally used for calculating sample size, are also given.

Meta-analysis in medicine.

When it comes to health care, everybody - medical professionals, policymakers and patients - wants to know what works and what does not. Every day clinicians debate, implicitly or explicitly, whether new research findings are convincing enough to change the way they practice. The quality of research varies, and so much information is being produced that it is impossible for anyone to know and evaluate it all. Traditionally, randomized controlled trials are considered gold standard study designs. However, if they report discordant results and generate controversies, then what should we look for? The answer to this imbroglio is meta-analysis. Steps in designing and conducting meta-analysis involve describing the purpose of meta-analysis, designing a research question, searching for studies, specifying study selection (inclusion and exclusion) and appraisal criteria, deciding data extraction procedures (including statistical reanalysis), assessing combinability of studies, selecting an analytical strategy (use of models and sensitivity analysis), anticipating systematic errors (biases) and limitations, and presenting and disseminating results of the meta-analysis. The Cochrane Collaboration is significantly contributing to the development of this area of research and making a noticeable dent on the practice of evidence based medicine across the globe. Meta-analytic approaches have been used to resolve long standing controversies in the field of medicine, including dermatology.

Hypertension among cotton textile workers.

The present cross sectional study on prevalence of hypertension was carried out among 514 cotton textile workers of Shri Bapurao Deshmukh Sut Gimi, Wardha. Using standard guidelines for measuring blood pressure and standard criteria for diagnosis of hypertension, 20.2% of the subjects were found to have raised systolic and/or diastolic blood pressure. The prevalence of hypertension was significantly higher among persons aged 35 years or more, in the present occupation for 10 years or more and those working in more noisy department.

Sexually transmitted infections in long distance truck drivers.

A study was undertaken in 670 long distance truck drivers to investigate prevalence of sexually transmitted infections--STI (HIV infection, syphilis, hepatitis-B infection and gonorrhoea) in Nagpur City, Central India. Standard laboratory procedures were followed for carrying out investigations i.e. ELISA for HIV infection, VDRL for syphilis, RPHA for hepatitis-B infection and gram staining for gonorrhoea. A total of 293 (43.7%) subjects had one or more sign/symptoms suggestive of STIs. The prevalence of HIV infection, syphilis, hepatitis-B infection and gonorrhoea was observed to be 15.2%, 21.9%, 5.1% and 6.7% respectively. In conclusion, this study recognized that long distance truck drivers were at high risk for getting STIs including HIV infection.

Factors responsible for delayed immunisation among children under 5 years of age.

Although immunisation coverage has increased substantially in recent years, still a sizable proportion of children are not being immunised at appropriate time. The present hospital based, pair matched, case control study was carried out at immunoprophylactic centre of Government Medical College and Hospital, Nagpur, to identify risk factors associated with delayed immunisation among children. This study included 139 children with a delay of more than 90 days for scheduled primary immunisation and equal number of matched control (for dose) receiving immunisation at appropriate time. The study identified significant association of family size [Odd's ratio (OR) = 7.3, 95% confidence interval (CI) = 1.5-35.6], number of children < 5 years (OR = 3.17, 95% CI = 1.1-9.9), sex (OR = 3, 95% CI = 1.2-7.4), paternal education (OR = 3.7, 95% CI = 1.6-8.5), maternal education (OR = 4, 95% CI = 1.5-10.9), socio-economic status (OR = 3.7, 95% CI = 1.1-13.2) and distance from health centre (OR = 4.7, 95% CI = 1.2-17.6) with delayed immunisation. Negligence (56%) and unawareness (22.7%) of parents were main reasons for delayed immunisation. Hence more stress on identified risk factors in the study will indirectly help in reducing the frequency of delayed immunisation.

Maternal age as a risk factor for stillbirth.

To Detect the risk of still birth in different maternal age, five year (1st January 1993 to 31st December 1997) record of Government Medical College, Nagpur were analysed. The rate of stillbirth was 2.5% (1138 stillbirth out of 46,443 deliveries) which was significantly associated with increasing maternal age (x2 = 182.3, df = 4, p < 0.001). Teenage pregnancy and elderly pregnancy were in significant risk as compared to 20-29 years age group for stillbirth (OR = 1.6, 95% C1 1.1-2.5; OR 2.6, 95% CI = 1.9-3.5 respectively).

National Vitamin A Prophylaxis Programme: need for change in current age strategy.

Child survival and Safe Motherhood Programme emphasises on giving vitamin A prophylaxis upto three years of age only, contrary to earlier practice of its administration upto six years of age, based on the assumption of reduction of serious manifestations of vitamin A deficiency three years of age onwards. A cross-sectional study enrolling 1094 children was done to investigate vitamin A deficiency in under six children in urban slums of Nagpur city in Central India in post CSSM scenario. Clinical as well as subclinical (detected by abnormal conjunctival impression cytology) assessment of vitamin A status was performed according to standard procedures, as per WHO recommendations. The overall prevalence of xerophthalmia was 8.7%. Only milder manifestations of xerophthalmia were observed. Significantly higher prevalence of xerophthalmia was observed in more than three years of age. Although nonsignificant, higher prevalence of subclinical vitamin A deficiency was observed in above three years of age group. In view of current age strategy for vitamin A supplementation (< or = 3 years) and observed higher prevalence of clinical and subclinical vitamin A deficiency above three years of age in this study (also endorsed by earlier studies) a call for review of current age strategy for vitamin A supplementation is warranted.

Dehydrational crisis from severe diarrhoea and risk of age-related cataract.

A group matched hospital based case-control study of 463 cases and equal number of controls was carried out at Government Medical College and Hospital, Nagpur to evaluate role of severe dehydrational crisis in age-related cataract development. The overall relative risk of age related cataract in relation to dehydrational crisis from severe diarrhoea was estimated to be 3.10 (2.28-4.20). The overall estimates of attributable risk per cent and population attributable risk per cent were calculated to be 0.67 (0.56-0.76) and 0.26 (0.18-0.35) respectively. In conclusion this study identified significant role of dehydrational crisis from severe diarrhoea in cataractogenesis.

Teenage pregnancy outcome: a record based study.

Present record based study was undertaken in Medical record section of Government medical college, Nagpur, to assess teenage as a risk factor for pregnancy complications, outcome, and operative or assisted delivery. Five year (January 1993 to December 1997) data was scanned, which gave sample of 1830 teenage pregnancies; while equal number of subsequent partly matched controls (> 20.29 years) were taken. Results showed proportion of low birth weight baby to be significantly greater in teenagers (p < 0.001). Operative interference was significantly greater in adult pregnancies (p < 0.001). Though stillbirth and preterm delivery was more in cases, difference was not statistically significant. Similarly toxaemia of pregnancy, premature rupture of membrane, placenta previa, accidental haemorrhage though more in adult pregnancies was statistically not significant. There were no differences in cogenital anamoly and twins between cases and controls. But breech deliveries were significantly (p < 0.001) more in adults.

Tobacco consumption practices and risk of oro-pharyngeal cancer: a case-control study in Central India.

A hospital based, group matched case control study was conducted with the objective to assess the association between tobacco consumption practices and risk of development of oro-pharyngeal cancer in Central India. The study included 123 cases of oro-pharyngeal cancer, diagnosed on the basis of histopathology at three tertiary care centers in Nagpur city. Each case was matched for age and sex with two hospital controls: one selected from non-cancer patients and another from patients having cancer of other sites. Tobacco chewing (OR=7.98, 95% CI 4.11-13.58) and tobacco smoking (OR=2.25, 95% CI 1.22-3.70) were found to be significantly associated with oro-pharyngeal cancer on unconditional multiple logistic regression analysis. Further analysis revealed a dose-response relationship between increasing frequency, duration and retention time of tobacco in mouth and risk of oro-pharyngeal cancer. Other risk factors which were also found to contribute significantly in the outcome of oro-pharyngeal cancer in the study population were: use of traditional/local substances (eg pan, betel nut, lime) with or without tobacco, use of tobacco containing material for teeth cleaning, type of smoking (eg bidi, chillum, cigarette) and outdoor occupations. High values of estimates of attributable risk percent (ARP) and population attributable risk percent (PARP) confirmed the positive impact of reduction or elimination of the tobacco consumption practices on reducing the risk of oro-pharyngeal cancer in the population of Central India.