Azithromycin in Labour Lowers Clinical Infections in Mothers and Newborns

Our recent study shows that Azithromycin, when given to women in labour, decreases bacterial infections in both women and newborns during the puerperal period. Findings from this study also depict the need for larger studies, designed to evaluate the effect of the intervention on severe morbidity and mortality.

In The Gambia, the rate of maternal mortality is one of the highest among all developing countries, and neonatal deaths represent approximately 40% of all deaths of children under five years of age. Hence, interventions that target maternal and neonatal morbidity and mortality are urgently needed in the region.

Infant during the trial

Infant during the trial

MRC Unit The Gambia (MRCG) recently completed a proof-of-concept double-blind trial in a periurban health facility in Western Gambia where women in labour were randomised to receive either an oral dose of 2 g of Azithromycin or placebo. The study was designed to determine the effect of the intervention on bacterial carriage (S aureus, GBS, and S pneumoniae) in nasopharyngeal swabs, breast milk samples, and vaginal swabs collected up to 28 days after delivery. Azithromycin substantially reduced bacterial carriage in both the mother and the newborn and also reduced by 60% the use of antibiotics during the puerperal period. A post-hoc analysis was conducted to assess the effect of the intervention on the occurrence of maternal and neonatal infections and fever.

The research was conducted by MRCG, in the peri-urban health facility in Western Gambia, and Dr Claire Oluwalana, Research Clinician of the trial, Disease Control and Elimination Theme, is the first author of this publication. Funded jointly by UK MRC, and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement (reference number MR/J010391/1) the findings were published in Pediatrics.

For this study, 829 mothers and their 830 newborns were recruited from April 2013 to April 2014. Sixteen infants died during the follow-up period. No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the Azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22–0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12–0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15–0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the Azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58–0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25–0.93; P = .034).

Dr Claire Oluwalana, Research Clinician of the trial, Disease Control and Elimination Theme

Dr Claire Oluwalana, Research Clinician of the trial, Disease Control and Elimination Theme

Commenting on the research findings, Dr Claire Oluwalana said, “Every newborn has a right to survival and no mother should die during pregnancy, labour or delivery. Infections are major contributions that lead to these deaths particularly in newborns. Simple and affordable interventions can be used to reduce maternal and neonatal morbidity and eventual mortality in our communities.

Our research findings showed that the use of Azithromycin in labour reduced infections in both mothers and their newborn infants – a major cause of death in the latter. “It is important to note that the prevalence of mastitis was lower in the Azithromycin group. Mastitis could lead to mother’s inability to breastfeed, poor milk production, leading to the early introduction of complementary feeds, diarrhoea, failure to thrive and deaths in their babies,” she added.

There were no maternal deaths during the trial. This proves that good intrapartum care, including intrapartum antibiotic prophylaxis, timely interventions during complicated labour, and good postnatal care have the potential to save the lives of mothers and their babies.

Read the full publication of American Academy of Pediatrics on Pediatrics http://pediatrics.aappublications.org/content/early/2017/01/25/peds.2016-2281