1. Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.
- Author
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Oladapo OT, Vogel JP, Piaggio G, Nguyen MH, Althabe F, Gülmezoglu AM, Bahl R, Rao SPN, De Costa A, Gupta S, Baqui AH, Khanam R, Shahidullah M, Chowdhury SB, Ahmed S, Begum N, D Roy A, Shahed MA, Jaben IA, Yasmin F, Rahman MM, Ara A, Khatoon S, Ara G, Akter S, Akhter N, Dey PR, Sabur MA, Azad MT, Choudhury SF, Matin MA, Goudar SS, Dhaded SM, Metgud MC, Pujar YV, Somannavar MS, Vernekar SS, Herekar VR, Bidri SR, Mathapati SS, Patil PG, Patil MM, Gudadinni MR, Bijapure HR, Mallapur AA, Katageri GM, Chikkamath SB, Yelamali BC, Pol RR, Misra SS, Das L, Nanda S, Nayak RB, Singh B, Qureshi Z, Were F, Osoti A, Gwako G, Laving A, Kinuthia J, Mohamed H, Aliyan N, Barassa A, Kibaru E, Mbuga M, Thuranira L, Githua NJ, Lusweti B, Ayede AI, Falade AG, Adesina OA, Agunloye AM, Iyiola OO, Sanni W, Ejinkeonye IK, Idris HA, Okoli CV, Irinyenikan TA, Olubosede OA, Bello O, Omololu OM, Olutekunbi OA, Akintan AL, Owa OO, Oluwafemi RO, Eniowo IP, Fabamwo AO, Disu EA, Agbara JO, Adejuyigbe EA, Kuti O, Anyabolu HC, Awowole IO, Fehintola AO, Kuti BP, Isah AD, Olateju EK, Abiodun O, Dedeke OF, Akinkunmi FB, Oyeneyin L, Adesiyun O, Raji HO, Ande ABA, Okonkwo I, Ariff S, Soofi SB, Sheikh L, Zulfiqar S, Omer S, Sikandar R, Sheikh S, Giordano D, Gamerro H, Carroli G, Carvalho J, Neilson J, Molyneux E, Yunis K, Mugerwa K, and Chellani HK
- Subjects
- Adult, Developing Countries, Female, Humans, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases epidemiology, Injections, Intramuscular, Pregnancy, Premature Birth, Risk, Stillbirth epidemiology, Dexamethasone administration & dosage, Glucocorticoids administration & dosage, Infant, Premature, Diseases prevention & control, Perinatal Death prevention & control, Prenatal Care
- 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. (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.)., (Copyright © 2020 Massachusetts Medical Society.)
- Published
- 2020
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