Journal article

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

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

BMC MEDICINE | BMC | Published : 2015

Abstract

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). Wo..

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Grants

Awarded by Bill & Melinda Gates Foundation


Awarded by European Union's Seventh Framework Programme FP7-HEALTH


Awarded by Pfizer Inc.


Awarded by National Health and Medical Research Council (NHMRC) Early Career Fellowship


Awarded by NHMRC Senior Research Fellowship


Funding Acknowledgements

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.