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1.
N Engl J Med ; 383(26): 2514-2525, 2020 12 24.
Artigo em Inglês | MEDLINE | ID: mdl-33095526

RESUMO

BACKGROUND: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).


Assuntos
Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Doenças do Prematuro/prevenção & controle , Morte Perinatal/prevenção & controle , Cuidado Pré-Natal , Adulto , Países em Desenvolvimento , Feminino , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/epidemiologia , Injeções Intramusculares , Gravidez , Nascimento Prematuro , Risco , Natimorto/epidemiologia
2.
Reprod Health ; 15(Suppl 1): 90, 2018 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-29945660

RESUMO

BACKGROUND: As per the World Health Organization, the nutritional status of women of reproductive age is important, as effects of undernutrition are propagated to future generations. More than one-third of Indian women in the reproductive age group are in a state of chronic nutritional deficiency during the preconception period leading to poor health and likely resulting in low birth weight babies. This study was aimed to assess the food insecurity and nutritional status of preconception women in a rural population of north Karnataka. METHODS: A total of 770 preconception women were enrolled across a district in Karnataka from selected primary health centre areas by a cluster sampling method. Data on socioeconomic status, food insecurity and obstetric history were collected by trained research assistants, interviewing women at home. In half of the participants, a 1 day 24 -hour dietary recalls were conducted by dietary assistants to assess the dietary intakes. Anthropometric measurements and haemoglobin estimation were carried out at the health centres. RESULTS: In the present study, a majority of the participants (64.8%) belonged to the lower socio-economic classes and the prevalence of food insecurity was 27.4%. A majority of the participants had mild (15.5%) to moderate (78.6%) anaemia. About one-third of the participants (36.6%) were underweight. Significant associations were found between socio-economic status and anaemia (p = 0.0006) and between food insecurity and anaemia (p = 0.0001). CONCLUSION: The nutritional status of preconception women was poor and anemia was more prevalent in low-socioeconomic and food insecure population.


Assuntos
Anemia/epidemiologia , Abastecimento de Alimentos , Estado Nutricional , Pobreza , Cuidado Pré-Concepcional , Magreza/epidemiologia , Adolescente , Adulto , Estudos Transversais , Feminino , Humanos , Índia/epidemiologia , Gravidez , População Rural , Fatores Socioeconômicos , Adulto Jovem
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