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We thank the participating women and their families; the PNGIMR clinical, administrative, logistics, and laboratory staff; the staff at all participating health centres and hospitals; Lisa Lansfield, Hector Morris, John Bolnga, Jaume Ordi, Albert Serra Pou, Eline Kattenberg, Celine Barnadas, Andrew Raiko, Jane Walker, Sylvia Soso, Nola Ndrewei, Clare Ryan, and Jacob Kumai; DSMB members Julie Simpson and James McCarthy; independent clinician (drug safety) Moses Laman; independent clinical monitor Honor Rose; and Christalla Hajisava. This study was funded by the Malaria in Pregnancy Consortium, through a grant from the Bill & Melinda Gates Foundation (46099); the Pregvax Consortium, through a grant from the European Union's Seventh Framework Programme FP7-2007-HEALTH (PREGVAX 201588) and the Spanish Government (EUROSALUD 2008 Programme); and Pfizer Inc., through an investigator-initiated research grant (WS394663). LJR received a National Health and Medical Research Council (NHMRC) Early Career Fellowship (# 1016443). IM received an NHMRC Senior Research Fellowship (# 1043345). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Sulphadoxine- pyrimethamine plus azithromycin for the prevention of low birthweight in Papua New Guinea: a randomised controlled trial

Publicado en:BMC Medicine. 13 (9): 9- - 2015-01-16 13(9), DOI: 10.1186/s12916-014-0258-3

Autores: Unger, Holger W.; Ome-Kaius, Maria; Wangnapi, Regina A.; Umbers, Alexandra J.; Hanieh, Sarah; Suen, Connie S. L. Li Wai; Robinson, Leanne J.; Rosanas-Urgell, Anna; Wapling, Johanna; Lufele, Elvin; Kongs, Charles; Samol, Paula; Sui, Desmond; Singirok, Dupain; Bardaji, Azucena; Schofield, Louis; Menendez, Clara; Betuela, Inoni; Siba, Peter; Mueller, Ivo; Rogerson, Stephen J.;

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Background: Intermittent preventive treatment in pregnancy has not been evaluated outside of Africa. Low birthweight (LBW, < 2,500 g) is common in Papua New Guinea (PNG) and contributing factors include malaria and reproductive tract infections. Methods: From November 2009 to February 2013, we conducted a parallel group, randomised controlled trial in pregnant women (<= 26 gestational weeks) in PNG. Sulphadoxine-pyrimethamine (1,500/75 mg) plus azithromycin (1 g twice daily for 2 days) (SPAZ) monthly from second trimester (intervention) was compared against sulphadoxine-pyrimethamine and chloroquine (450 to 600 mg, daily for three days) (SPCQ) given once, followed by SPCQ placebo (control). Women were assigned to treatment (1: 1) using a randomisation sequence with block sizes of 32. Participants were blinded to assignments. The primary outcome was LBW. Analysis was by intention to treat. Results: Of 2,793 women randomised, 2,021 (72.4%) were included in the primary outcome analysis (SPCQ: 1,008; SPAZ: 1,013). The prevalence of LBW was 15.1% (305/2,021). SPAZ reduced LBW (risk ratio [RR]: 0.74, 95% CI: 0.60-0.91, P = 0.005; absolute risk reduction (ARR): 4.5%, 95% CI: 1.4-7.6; number needed to treat: 22), and preterm delivery (0.62, 95% CI: 0.43-0.89, P = 0.010), and increased mean birthweight (41.9 g, 95% CI: 0.2-83.6, P = 0.049). SPAZ reduced maternal parasitaemia (RR: 0.57, 95% CI: 0.35-0.95, P = 0.029) and active placental malaria (0.68, 95% CI: 0.47-0.98, P = 0.037), and reduced carriage of gonorrhoea (0.66, 95% CI: 0.44-0.99, P = 0.041) at second visit. There were no treatment-related serious adverse events (SAEs), and the number of SAEs (intervention 13.1% [181/1,378], control 12.7% [174/1,374], P = 0.712) and AEs (intervention 10.5% [144/1,378], control 10.8% [149/1,374], P = 0.737) was similar. A major limitation of the study was the high loss to follow-up for birthweight. Conclusions: SPAZ was efficacious and safe in reducing LBW, possibly acting through multiple mechanisms including the effect on malaria and on sexually transmitted infections. The efficacy of SPAZ in the presence of resistant parasites and the contribution of AZ to bacterial antibiotic resistance require further study. The ability of SPAZ to improve pregnancy outcomes warrants further evaluation.

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