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. 2023 Aug 30;13(8):e068487.
doi: 10.1136/bmjopen-2022-068487.

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

Jennifer Hemingway-Foday  1 , Alan Tita  2 , Elwyn Chomba  3 , Musaku Mwenechanya  3 , Trecious Mweemba  3 , Tracy Nolen  4 , Adrien Lokangaka  5   6 , Antoinette Tshefu Kitoto  5   6 , Gustave Lomendje  6 , Patricia L Hibberd  7 , Archana Patel  8   9 , Prabir Kumar Das  8 , Kunal Kurhe  8 , Shivaprasad S Goudar  10 , Avinash Kavi  10 , Mrityunjay Metgud  10 , Sarah Saleem  11 , Shiyam S Tikmani  11 , Fabian Esamai  12 , Paul Nyongesa  12 , Amos Sagwe  12 , Lester Figueroa  13 , Manolo Mazariegos  13 , Sk Masum Billah  14   15 , Rashidul Haque  15 , Md Shahjahan Siraj  15 , Robert L Goldenberg  16 , Melissa Bauserman  17 , Carl Bose  17 , Edward A Liechty  18 , Osayame A Ekhaguere  18 , Nancy F Krebs  19 , Richard Derman  20 , William A Petri  21 , Marion Koso-Thomas  22 , Elizabeth McClure  4 , Waldemar A Carlo  2
Affiliations

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

Jennifer Hemingway-Foday et al. BMJ Open. .

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).

Keywords: Clinical trials; Maternal medicine; NEONATOLOGY; OBSTETRICS; PUBLIC HEALTH.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study Flowchart. *If early consent, confirmation of eligibility and reconfirmation of consent required.
See this image and copyright information in PMC

References

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