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

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Titel: 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
Beteiligte: Hemingway-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; [...]
Erschienen: BMJ, 2023
Erschienen in: BMJ Open
Sprache: Englisch
DOI: 10.1136/bmjopen-2022-068487
ISSN: 2044-6055
Schlagwörter: General Medicine
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Beschreibung: <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT03871491">NCT03871491</jats:ext-link>(<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT03871491?term=NCT03871491&draw=2&rank=1">https://clinicaltrials.gov/ct2/show/NCT03871491?term=NCT03871491&draw=2&rank=1</jats:ext-link>).</jats:p></jats:sec>
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