title: Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial.
abstract: OBJECTIVE
  We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections.
  
  
  METHODS
  This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery.
  
  
  RESULTS
  From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). 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).
  
  
  CONCLUSIONS
  Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted.
authors.affiliation: Medical Research Council Unit, Banjul, The Gambia.
authors.forename: Claire
authors.initials: C
authors.lastname: Oluwalana
authors.affiliation: Medical Research Council Unit, Banjul, The Gambia.
authors.forename: Bully
authors.initials: B
authors.lastname: Camara
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Christian
authors.initials: C
authors.lastname: Bottomley
authors.affiliation: London School of Economics, London, United Kingdom.
authors.forename: Sean
authors.initials: S
authors.lastname: Goodier
authors.affiliation: Medical Research Council Unit, Banjul, The Gambia.
authors.forename: Abdoulie
authors.initials: A
authors.lastname: Bojang
authors.affiliation: Medical Research Council Unit, Banjul, The Gambia.|Imperial College, London, United Kingdom.
authors.forename: Beate
authors.initials: B
authors.lastname: Kampmann
authors.affiliation: Ministry of Health and Social Welfare, Banjul, The Gambia; and.
authors.forename: Samba
authors.initials: S
authors.lastname: Ceesay
authors.affiliation: Medical Research Council Unit, Banjul, The Gambia.|London School of Hygiene and Tropical Medicine, London, United Kingdom.|Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.affiliation: Medical Research Council Unit, Banjul, The Gambia; aroca@mrc.gm.|London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Anna
authors.initials: A
authors.lastname: Roca
mesh_terms: D000284:Administration, Oral; D017963:Azithromycin / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000517:prevention & control*; D002353:Carrier State / Q000517:prevention & control; D003906:Developing Countries; D004311:Double-Blind Method; D005260:Female; D005335:Fever of Unknown Origin / Q000517:prevention & control; D005714:Gambia; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control*; D008413:Mastitis / Q000517:prevention & control; D011008:Pneumococcal Infections / Q000517:prevention & control; D011247:Pregnancy; D011645:Puerperal Infection / Q000517:prevention & control*; D017192:Skin Diseases, Bacterial / Q000517:prevention & control; D013203:Staphylococcal Infections / Q000517:prevention & control; D013211:Staphylococcus aureus; D013290:Streptococcal Infections / Q000517:prevention & control; D013292:Streptococcus agalactiae
chemical_list: D017963:Azithromycin