Document Type
Article
Publication Date
8-30-2023
Abstract
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 Citation
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; 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.https://jdc.jefferson.edu/gha/31
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Language
English
Comments
This article is the author’s final published version in BJM Open, Volume 13, Issue 8, August 2023, Article number e068487.
The published version is available at https://doi.org/10.1136/bmjopen-2022-068487.