1. Antenatal Dexamethasone for Early Preterm Birth in Low-resource Countries
- Author
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L. Thuranira, N. Akhter, A.D. Isah, Theresa Azonima Irinyenikan, F.B. Akinkunmi, B. Singh, A. Barassa, Zahida Qureshi, I.P. Eniowo, Olufemi T Oladapo, Ebunoluwa Aderonke Adejuyigbe, I.K. Ejinkeonye, Fredrick Were, N. Aliyan, Sana Sheikh, Nazma Begum, G. Ara, S. Gupta, Fernando Althabe, N.J. Githua, Gilda Piaggio, Geetanjali Katageri, Daniel Giordano, M.M. Rahman, O.O. Iyiola, O.A. Olutekunbi, Oluwafemi Kuti, A. Laving, Kidza Mugerwa, H. Mohamed, José Ferreira de Carvalho, Rajiv Bahl, R. Sikandar, O.F. Dedeke, L. Das, Yeshita V. Pujar, L. Oyeneyin, H.O. Raji, E.K. Olateju, S.R. Bidri, Ahmet Metin Gülmezoglu, O. Bello, M.R. Gudadinni, A. D Roy, S.F. Choudhury, P.G. Patil, A.O. Fehintola, Salahuddin Ahmed, Mrityunjay C Metgud, S.B. Chikkamath, R. Khanam, M. Shahidullah, H.K. Chellani, S.S. Mathapati, O.A. Adesina, Shabina Ariff, John Kinuthia, E. Molyneux, R.R. Pol, E.A. Disu, S.P.N. Rao, M. A. Matin, J.O. Agbara, A. De Costa, Hadiza Abdulaziz Idris, Khalid Yunis, M. Mbuga, Hugo Gamerro, S. Akter, R.B. Nayak, M.A. Shahed, Alfred Osoti, M.A. Sabur, B. Lusweti, A. Ara, Ashalata Mallapur, M.T. Azad, I.O. Awowole, S.B. Chowdhury, Adejumoke I. Ayede, R.O. Oluwafemi, Guillermo Carroli, A.B.A. Ande, S.B. Soofi, Sunil S Vernekar, M. M. Patil, L. Sheikh, F. Yasmin, B.P. Kuti, Abdullah H Baqui, B.C. Yelamali, S. Omer, Adesina Lawrence Akintan, A.G. Falade, A.M. Agunloye, C.V. Okoli, Okonkwo, O.A. Olubosede, O. Abiodun, A.O. Fabamwo, James P Neilson, My Huong Nguyen, Veena Herekar, George Gwako, O.M. Omololu, H.R. Bijapure, S. Zulfiqar, P.R. Dey, S. Nanda, Manjunath S Somannavar, H.C. Anyabolu, W. Sanni, Olorunfemi O. Owa, Joshua P. Vogel, Sujata Misra, O. Adesiyun, I.A. Jaben, S. Khatoon, Shivaprasad S. Goudar, E. Kibaru, Sangappa M. Dhaded, Oladapo, Olufemi, T, Vogel, Joshua P, Piaggio, Gilda, Nguyen, My-Huong, and Maranna, Sandhya
- Subjects
Adult ,Risk ,medicine.medical_specialty ,Low resource ,Perinatal Death ,Prenatal care ,Infant, Premature, Diseases ,Injections, Intramuscular ,Dexamethasone ,purl.org/becyt/ford/3.3 [https] ,low-resource countries ,Pregnancy ,randomized trial ,medicine ,Humans ,Developing Countries ,Glucocorticoids ,Obstetrics ,business.industry ,Incidence (epidemiology) ,Infant, Newborn ,preterm birth ,Prenatal Care ,General Medicine ,Infant, Low Birth Weight ,Stillbirth ,medicine.disease ,Interim analysis ,Low birth weight ,Premature birth ,Relative risk ,Early preterm birth ,Gestation ,Premature Birth ,purl.org/becyt/ford/3 [https] ,Female ,medicine.symptom ,business ,pregnant women ,Infant, Premature ,medicine.drug - Abstract
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. Fil: Oladapo, Olufemi T.. Organizacion Mundial de la Salud; Argentina Fil: Vogel, Joshua P.. Organizacion Mundial de la Salud; Argentina Fil: Piaggio, Gilda. Organizacion Mundial de la Salud; Argentina Fil: Nguyen, My-Huong. Organizacion Mundial de la Salud; Argentina Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Metin Gülmezoglu, A.. Organizacion Mundial de la Salud; Argentina Fil: Bahl, Rajiv. Organizacion Mundial de la Salud; Argentina Fil: Rao, Suman P.N.. Organizacion Mundial de la Salud; Argentina Fil: de Costa, Ayesha. Organizacion Mundial de la Salud; Argentina Fil: Gupta, Shuchita. Organizacion Mundial de la Salud; Argentina Fil: Shahidullah, Mohammod. No especifíca; Fil: Chowdhury, Saleha B.. No especifíca; Fil: Ara, Gulshan. No especifíca; Fil: Akter, Shaheen. No especifíca; Fil: Akhter, Nasreen. No especifíca; Fil: Dey, Probhat R.. No especifíca; Fil: Abdus Sabur, M.. No especifíca; Fil: Azad, Mohammad T.. No especifíca; Fil: Choudhury, Shahana F.. No especifíca; Fil: Matin, M.A.. No especifíca; Fil: Goudar, Shivaprasad S.. No especifíca; Fil: Dhaded, Sangappa M.. No especifíca; Fil: Metgud, Mrityunjay C.. No especifíca; Fil: Pujar, Yeshita V.. No especifíca; Fil: Somannavar, Manjunath S.. No especifíca; Fil: Vernekar, Sunil S.. No especifíca; Fil: Herekar, Veena R.. No especifíca; Fil: Bidri, Shailaja R.. No especifíca; Fil: Mathapati, Sangamesh S.. No especifíca; Fil: Patil, Preeti G.. No especifíca; Fil: Patil, Mallanagouda M.. No especifíca; Fil: Gudadinni, Muttappa R.. No especifíca; Fil: Bijapure, Hidaytullah R.. No especifíca; Fil: Mallapur, Ashalata A.. No especifíca; Fil: Katageri, Geetanjali M.. No especifíca; Fil: Chikkamath, Sumangala B.. No especifíca; Fil: Yelamali, Bhuvaneshwari C.. No especifíca; Fil: Pol, Ramesh R.. No especifíca; Fil: Misra, Sujata S.. No especifíca; Fil: Das, Leena. No especifíca
- Published
- 2021
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