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OBJECTIVE: Postpartum hemorrhage (PPH), a major cause of maternal mortality and morbidity in low-income countries, can occur unpredictably. This study examined the sociodemographic, clinical, and perinatal characteristics of low-risk women who experienced PPH. METHODS: This analysis was conducted using data on 1620 women from a randomized trial testing oral misoprostol for prevention of PPH in rural India. RESULTS: Of the women, 9.2% experienced PPH. No maternal or sociodemographic factors and few perinatal factors differed between women with PPH and those without, other than treatment with misoprostol. Having fewer than 4 prenatal visits and lack of iron supplementation increased the risk for PPH (P<0.001 and P=0.037, respectively). Several factors unknown until the second stage of labor (perineal tear and birth weight) were also associated (P=0.003). CONCLUSIONS: Among women at low risk for PPH, there were few factors associated with further risk. Given that PPH can occur without warning, rural communities should consider ways to increase both primary prevention (iron supplementation, AMTSL) and secondary prevention of PPH (availability of obstetric first aid, availability of transport, and availability of emergency obstetric care).
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Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/etiologia , Cuidado Pré-Natal , Adulto , Feminino , Humanos , Índia/epidemiologia , Mortalidade Materna , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Hemorragia Pós-Parto/tratamento farmacológico , Gravidez , Fatores de Risco , População RuralRESUMO
BACKGROUND: Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. METHODS: In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. FINDINGS: Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. INTERPRETATION: Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.
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Misoprostol/uso terapêutico , Ocitócicos/uso terapêutico , Hemorragia Pós-Parto/prevenção & controle , Administração Oral , Feminino , Parto Domiciliar , Humanos , Índia , Tocologia , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Áreas de Pobreza , Saúde da População RuralRESUMO
BACKGROUND: Maternal mortality rates in India are estimated at 560/100,000 live births and postpartum hemorrhage (PPH) accounts for 35-56% of these deaths. Given that 50% of births in rural India occur at home, oral Misoprostol administered by minimally trained midwives may be an effective uterotonic agent for preventing PPH when the use of other uterotonics is not feasible. While the import for testing the effectiveness of this intervention may be readily obvious, the elements essential for the conduct of a scientific study in rural areas served by indigenous health workers may not be as evident. METHODS: We present the design as well as the preparation and development of an ongoing NICHD sponsored U.S.-Indian collaborative randomized, placebo-controlled, clinical trial (RCT) conducted in four Primary Health Center areas of Belgaum District, Karnataka, India. The primary goal of the trial is to assess the effectiveness of Misoprostol 600 microg orally in reducing the incidence of acute PPH (> or = 500 mL) in women delivering at home or in neighboring sub-centers. 1600 pregnant women will be randomized to receive Misoprostol or placebo immediately post-delivery of the infant. However, beyond testing the scientific merit of the RCT, this study also tests the feasibility of having indigenous midwives regularly using Misoprostol in rural areas as well as the willingness of these communities to accept this intervention. In addition, this paper also explores the international and community collaborations necessary for the conduct of this study. FINDINGS: It is necessary to have several critical elements in place, including international collaboration between the Indian and US research sites, funding through a private/public collaboration and trained scientists, as well as commitment from the community for the successful conduct of such a study. In the development and implementation of a RCT, careful attention must be paid to the training of field personnel involved in the delivery process and developing a data collection and monitoring system to ensure that information gathered is valid. CONCLUSIONS: A joint U.S.-Indian collaboration to test the efficacy and the feasibility of an innovative method to reduce PPH can serve as collaborative model to develop additional interventions to improve maternal mortality and morbidity. If Misoprostol is shown to be sufficiently safe and efficacious in the prevention of PPH, the appropriate government agencies will be encouraged to make the drug available to midwives (ANMs) and rurally located physicians for whom parenteral medications are either not permitted or impractical and/or unavailable. Such a project can serve as a model applicable to rural settings throughout the developing world for improving delivery practices and reducing maternal mortality and morbidity. These are important public health concerns in India and other developing nations.
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Cooperação Internacional , Tocologia , Misoprostol/uso terapêutico , Ocitócicos/uso terapêutico , Hemorragia Pós-Parto , Saúde da População Rural , Estudos de Viabilidade , Feminino , Diretrizes para o Planejamento em Saúde , Serviços de Saúde , Necessidades e Demandas de Serviços de Saúde , Humanos , Índia , Serviços de Saúde Materna/normas , Mortalidade Materna , Tocologia/educação , Tocologia/normas , Hemorragia Pós-Parto/tratamento farmacológico , Hemorragia Pós-Parto/prevenção & controle , Gravidez , Estados UnidosRESUMO
BACKGROUND: Health status of infants is a sensitive indicator of development and factors influencing it need to be better understood. OBJECTIVES: This study was conducted to search for factors associated with morbidity among infants and to find out their influence on weight gain during infancy. MATERIALS AND METHODS: This longitudinal study was undertaken in south India from November 2004 till April 2006. A birth cohort of all children born during first 6 months of the study period were assessed at enrollment and followed up monthly till they attained 1 year of age. RESULTS: Incidence of morbidity among infants was found to be least among those exclusively breast fed (EBF) for 6 months and most when EBF for less than 6 months (P = 0.045). It was also more when infants were weaned with a combination of animal milk, formula milk, semi-solids and solid diet and least when weaned only with semi-solids and solids (P = 0.018). Diarrheal episodes were more in infants who were bottle-fed (P < 0.001). Weight gain between 6(th) and 12(th) month of infancy was found to be significantly affected by various morbidities (P = 0.001). Incidence of morbidities was less among preterm babies and more among partially immunized (P < 0.001) babies with birth order ≥ 3 (P = 0.012), babies of mothers with low socio-economic and educational status. Delayed milestones during infancy was seen more in babies with history of birth asphyxia (P = 0.018). CONCLUSION: Several factors influenced incidence of morbidities and these morbidities had a negative effect on weight gain. Hence these factors need to be addressed to promote better child health.
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BACKGROUND: Rearing practices are a major determinant of nutritional and health status of infants. Therefore these practices need to be better understood. OBJECTIVES: To find out infant rearing practices in the study area. MATERIALS AND METHODS: A longitudinal study was conducted on a birth cohort of 194 infants. Information on rearing practices and anthropometric measurements were recorded every month for a period of 1 year. RESULTS: Only 67 (34.5%) newborns were breast fed within half an hour of delivery. Prelacteal feeds was given to 65 (33.5%) newborns and this was seen more among home deliveries (P=0.018). Demand feeding was practiced by 169 (87.1%) mothers. Exclusive breast feeding (EBF) for 6 months was practiced by 81 (41.7%) mothers. Bottle feeding was seen in 7 (3.6%) cases. Weight gain during infancy was found to be maximum when infants were EBF for 6 months (P<0.001) and weaned with semi-solid and solid diet alone in the following 6 months (P=0.002). Gain in all anthropometric measurements was more in the initial 6 months of infancy compared to latter. Four (2.1%) infants were malnourished. Oil massage before bath was practiced by 189 (97.4%) mothers. Over 50% mothers practiced oil application to eyes or ears of infants. Delayed initiation of bath (beyond 1week) was seen in 15 (7.7%) cases. CONCLUSION: Faulty rearing practices need to be corrected in order to improve the health status of infants.
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BACKGROUND: Low birth weight (LBW) is a major public health problem in many developing countries, especially so in India. Although we do not know all the causes of LBW, maternal and environmental factors appear to be significant risk factors in its occurrence. OBJECTIVES: To know the factors affecting the birth weight of a newborn and to estimate the prevalence of LBW. METHODS: The present study was carried out amongst 1138 pregnant women and their newborns residing in area covered by Kinaye Primary Health Centre in rural Karnataka, India. The study was conducted from 1(st) June 2008 to 31(st) December 2009. RESULTS: The mean birth weight of newborns was 2.6 kg with a range of 1.2 to 3.8 kg. The prevalence of LBW was 22.9%. Among the studied risk factors, 25 of them were significantly associated with the birth weight of a newborn on univariate logistic regression analysis. Maternal education [Odds Ratio (OR) 3.2], exposure to passive smoking [OR 2.3], age at first pregnancy ≥25 years [OR 3.6], birth interval <2 years [OR 2.4], previous history of LBW baby [OR 3.3], weight gain ≤4 kg during pregnancy [OR 7.0], maternal weight at last week of gestation ≤45 kg [OR 2.3], pregnancy induced hypertension [OR 3.3], high risk pregnancy [OR 3.6] and late antenatal registration [OR 3.6] emerged as significant risk factors on multivariate analysis. CONCLUSION: The problem of LBW is multidimensional, and hence, we need an integrated approach incorporating medical, social, economical and educational measures to address this issue.
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Inquéritos Epidemiológicos , Recém-Nascido de Baixo Peso , Adulto , Feminino , Humanos , Índia/epidemiologia , Recém-Nascido , Razão de Chances , Gravidez , Prevalência , Fatores de Risco , Adulto JovemRESUMO
To study the incidence and types of morbidity in the first year of life in a birth cohort, a longitudinal study. This study was undertaken in northern part of Karnataka state in India. Birth cohort consisted of all the children born during first six months of the study period. They were assessed at the time of enrollment and monthly follow up was done till they attained one yr of age. Out of the 194 newborns, 46.4% were boys and 53.6% were girls. 24.8% of newborns were of low birth weight and 5.1% were preterm. Four (2.1%) had congenital anomalies and 2.5% developed birth asphyxia. Diarrhea (10.8%) and skin diseases (8.2%) were the commonest morbidities in the neonatal period. The incidence of morbidity was 3.28 per infant per yr. It was more among boys and in the second half of infancy. Commonest morbidities during infancy were respiratory tract infection (62.4%), diarrhea 42.8% and skin diseases (21.6%). Incidence of disease in infancy highlights the need to improve and plan health programmes.
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Morbidade , Diarreia Infantil/epidemiologia , Feminino , Humanos , Índia/epidemiologia , Lactente , Recém-Nascido , Infecções/epidemiologia , Masculino , Infecções RespiratóriasRESUMO
The present study was conducted with the objective to determine the treatment seeking behavior of parents/caretakers for injuries sustained by children under five years of age in rural Southern India. Out of 325 children, 39.7% were treated by a health personnel, 29% received home remedy while the rest (31.3%) did not receive any treatment. Abrasion (72.6%) was the commonest type of injury observed. 47.3% of injuries were treated within an hour of onset. Commonest home remedies used ranged from antiseptics to folk remedies. Training of parents and caretakers for hygienic and timely treatment of injury is recommended.
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População Rural/estatística & dados numéricos , Ferimentos e Lesões/epidemiologia , Área Programática de Saúde , Pré-Escolar , Feminino , Seguimentos , Humanos , Índia/epidemiologia , Masculino , Prevalência , Índice de Gravidade de DoençaRESUMO
OBJECTIVE: To investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH). METHODS: One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe. RESULTS: Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns. CONCLUSIONS: Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.
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Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Hemorragia Pós-Parto/prevenção & controle , População Rural , Administração Oral , Diarreia Infantil/induzido quimicamente , Diarreia Infantil/epidemiologia , Feminino , Febre/induzido quimicamente , Febre/epidemiologia , Humanos , Incidência , Índia/epidemiologia , Recém-Nascido , Troca Materno-Fetal/efeitos dos fármacos , Náusea/induzido quimicamente , Náusea/epidemiologia , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Placebos , Gravidez , Características de Residência , Estremecimento/efeitos dos fármacos , Vômito/induzido quimicamente , Vômito/epidemiologiaRESUMO
OBJECTIVE: The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss >or= 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. METHODS: We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n = 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices. RESULTS: As the study duration increased, the duration of the second stage of labor decreased (-0.12, p = 0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201-0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM. CONCLUSIONS: Declining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial.