Dataset Information

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.

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).

SUBMITTER: Hemingway-Foday J

PROVIDER: S-EPMC10471878 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

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.

Hemingway-Foday Jennifer J Tita Alan A Chomba Elwyn E Mwenechanya Musaku M Mweemba Trecious T Nolen Tracy T Lokangaka Adrien A Tshefu Kitoto Antoinette A Lomendje Gustave G Hibberd Patricia L PL Patel Archana A Das Prabir Kumar PK Kurhe Kunal K Goudar Shivaprasad S SS Kavi Avinash A Metgud Mrityunjay M Saleem Sarah S Tikmani Shiyam S SS Esamai Fabian F Nyongesa Paul P Sagwe Amos A Figueroa Lester L Mazariegos Manolo M Billah Sk Masum SM Haque Rashidul R Shahjahan Siraj Md M Goldenberg Robert L RL Bauserman Melissa M Bose Carl C Liechty Edward A EA Ekhaguere Osayame A OA Krebs Nancy F NF Derman Richard R Petri William A WA Koso-Thomas Marion M McClure Elizabeth E Carlo Waldemar A WA

BMJ open 20230830 8

<h4>Introduction</h4>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 neona ...[more]

PMID: 37648383

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Project description:BackgroundOligohydramnios is a condition of abnormally low amniotic fluid volume that has been associated with poor pregnancy outcomes. To date, the prevalence of this condition and its outcomes has not been well described in low and low-middle income countries (LMIC) where ultrasound use to diagnose this condition in pregnancy is limited. As part of a prospective trial of ultrasound at antenatal care in LMICs, we sought to evaluate the incidence of and the adverse maternal, fetal and neonatal outcomes associated with oligohydramnios.MethodsWe included data in this report from all pregnant women in community settings in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo (DRC) who received a third trimester ultrasound as part of the First Look Study, a randomized trial to assess the value of ultrasound at antenatal care. Using these data, we conducted a planned secondary analysis to compare pregnancy outcomes of women with to those without oligohydramnios. Oligohydramnios was defined as measurement of an Amniotic Fluid Index less than 5 cm in at least one ultrasound in the third trimester. The outcomes assessed included maternal morbidity and fetal and neonatal mortality, preterm birth and low-birthweight. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models using general estimating equations to account for the correlation of outcomes within cluster.ResultsOf 12,940 women enrolled in the clusters in Guatemala, Pakistan, Zambia and the DRC in the First Look Study who had a third trimester ultrasound examination, 87 women were diagnosed with oligohydramnios, equivalent to 0.7% of those studied. Prevalence of detected oligohydramnios varied among study sites; from the lowest of 0.2% in Zambia and the DRC to the highest of 1.5% in Pakistan. Women diagnosed with oligohydramnios had higher rates of hemorrhage, fetal malposition, and cesarean delivery than women without oligohydramnios. We also found unfavorable fetal and neonatal outcomes associated with oligohydramnios including stillbirths (OR 5.16, 95%CI 2.07, 12.85), neonatal deaths < 28 days (OR 3.18, 95% CI 1.18, 8.57), low birth weight (OR 2.10, 95% CI 1.44, 3.07) and preterm births (OR 2.73, 95%CI 1.76, 4.23). The mean birth weight was 162 g less (95% CI -288.6, - 35.9) with oligohydramnios.ConclusionsOligohydramnos was associated with worse neonatal, fetal and maternal outcomes in LMIC. Further research is needed to assess effective interventions to diagnose and ultimately to reduce poor outcomes in these settings.Trial registrationNCT01990625.

Project description:BackgroundThere is no consistent operationalization of effective coverage (EC) across studies. Therefore, this scoping review synthesized evidence on the definitions and measurement approaches, outcomes reported, and the factors that are associated with variations in quality-adjusted EC estimates of maternal and neonatal healthcare services in low- and middle-income countries.MethodsArticle search was conducted using PubMed, Embase, Google Scholar, and other databases. Then, title, abstract, and full text screenings for inclusion were performed by two authors independently and disagreements were resolved through discussion. In case of duplication, the full-text published articles were retained, and the results are presented using the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for Scoping Reviews checklist as a guide.ResultsOverall, 36 articles were included in this scoping review. In most articles, EC has been defined from the perspectives of people in need utilizing healthcare services in well-equipped health facilities and from actual receipt of quality services. In addition, usage, instead of need, has been used as a domain in estimating EC in some instances. Effective coverage ranged from 0% for different services including for post-partum care, to 84% for antenatal care. Moreover, different socio-demographic factors including wealth index, education, and residence are found to have an association with variations in EC of maternal and neonatal healthcare services with the wealthiest, most educated, and those living in urban areas having higher estimates. From the supply side, numerous factors, particularly health facility capacity-related constraints, have been reported to be associated with low EC of those services.ConclusionsThe variability in the definition and measurement approaches of EC across studies emphasizes the need for standardization for better comparison in future research. We recommend that quality-adjusted EC be defined in two ways: intervention-specific service delivery EC and general service delivery EC. In addition, disparities in EC are observed among women with different socioeconomic status including educational level and wealth index. Organizational capacity constraints and other health system and societal factors also contributed to variations in EC.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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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