INTRODUCTION: Maternal and neonatal infections are among the most frequent causes of maternal and neonatal mortality, and current antibiotic strategies have been ineffective in preventing many of these deaths. A randomised clinical trial conducted in a single site in The Gambia showed that treatment with an oral dose of 2 g azithromycin versus placebo for all women in labour reduced certain maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. In a large, multinational randomised trial, we will evaluate the impact of azithromycin given in labour to improve maternal and newborn outcomes.
METHODS AND ANALYSIS: This randomised, placebo-controlled, multicentre clinical trial includes two primary hypotheses, one maternal and one neonatal. The maternal hypothesis is to test whether a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labour will reduce maternal death or sepsis. The neonatal hypothesis will test whether this intervention will reduce intrapartum/neonatal death or sepsis. The intervention is a single, prophylactic intrapartum oral dose of 2 g azithromycin, compared with a single intrapartum oral dose of an identical appearing placebo. A total of 34 000 labouring women from 8 research sites in sub-Saharan Africa, South Asia and Latin America will be randomised with a one-to-one ratio to intervention/placebo. In addition, we will assess antimicrobial resistance in a sample of women and their newborns.
ETHICS AND DISSEMINATION: The study protocol has been reviewed and ethics approval obtained from all the relevant ethical review boards at each research site. The results will be disseminated via peer-reviewed journals and national and international scientific forums.
TRIAL REGISTRATION NUMBER: NCT03871491 (https://clinicaltrials.gov/ct2/show/NCT03871491?term=NCT03871491&draw=2&rank=1).
Recommended CitationHemingway-Foday, Jennifer; Tita, Alan; Chomba, Elwyn; Mwenechanya, Musaku; Mweemba, Trecious; Nolen, Tracy; Lokangaka, Adrien; Tshefu Kitoto, Antoinette; Lomendje, Gustave; Hibberd, Patricia L.; Patel, Archana; Das, Prabir Kumar; Kurhe, Kunal; Goudar, Shivaprasad S; Kavi, Avinash; Metgud, Mrityunjay; Saleem, Sarah; Tikmani, Shiyam S.; Esamai, Fabian; Nyongesa, Paul; Sagwe, Amos; Figueroa, Lester; Mazariegos, Manolo; Billah, Sk Masum; Haque, Rashidul; Shahjahan Siraj, Md; Goldenberg, Robert L.; Bauserman, Melissa; Bose, Carl; Liechty, Edward A.; Ekhaguere, Osayame A.; Krebs, Nancy F.; Derman, Richard; Petri, William A.; Koso-Thomas, Marion; McClure, Elizabeth; and Carlo, Waldemar A., "Prevention of Maternal and Neonatal Death/Infections with a Single Oral Dose of Azithromycin in Women in Labour in Low-Income and Middle-Income Countries (A-PLUS): A Study Protocol for a Multinational, Randomised Placebo-Controlled Clinical Trial" (2023). Global Health Articles. Article 31.
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