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Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth
Alan T N Tita1, Waldemar A Carlo1, Elizabeth M McClure1
1From the University of Alabama at Birmingham, Birmingham (A.T.N.T., W.A.C.); RTI International, Durham (E.M.M., J.J.H.-F., J.L.M., T.L.N.), and the University of North Carolina at Chapel Hill, Chapel Hill (M.B., C.B.) - both in North Carolina; University Teaching Hospital, Lusaka, Zambia (M. Mwenechanya, E.C.); Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (A.K., M.C.M., S.S.G.), Mahatma Gandhi Institute of Medical Sciences, Sewagram (P.S.), Government Medical College (M.W.) and Lata Medical Research Foundation (A.P.), Nagpur, and Datta Meghe Institute of Medical Sciences, Wardha (A.P.) - all in India; Thomas Jefferson University, Philadelphia (R.D.); Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo (A.L., A.T.); Boston University School of Public Health, Boston (P.L.H.); Moi University School of Medicine, Eldoret, Kenya (P.N., F.E.); Indiana School of Medicine, University of Indiana, Indianapolis (O.A.E., S.B.); Aga Khan University, Karachi, Pakistan (S.J., S.S.T., S.S.); Columbia University School of Medicine, New York (R.L.G.); the International Center for Diarrheal Disease Research, Dhaka (S.M.B., R.H.), and LAMB Hospital, Parbattipur (R.L.) - both in Bangladesh; the University of Sydney, Sydney (S.M.B.); the University of Virginia, Charlottesville (W.P.); Instituto de Nutrición de Centroamérica y Panamá, Guatemala City, Guatemala (L.F., M. Mazariegos); the University of Colorado-Anschutz Medical Campus, Denver (N.F.K.); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (M.K.-T.).
Background:
The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death.
Methods:
In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit.
Results:
A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events.
Conclusions:
Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; A-PLUS ClinicalTrials.gov number, NCT03871491.).
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