Published online June 29, 2009
PEDIATRICS Vol. 124 No. 1 July 2009, pp. e137-e144 (doi:10.1542/peds.2008-1873)
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ARTICLE

Intrapartum Antibiotic Exposure and Early Neonatal, Morbidity, and Mortality in Africa

George Kafulafula, MBBS, FCOG(SA), MMeda, Anthony Mwatha, MSb, Ying Qing Chen, PhDb, Said Aboud, MDc, Francis Martinson, MD, PhDd, Irving Hoffman, PA, MPHd, Wafaie Fawzi, MD, DrPHe, Jennifer S. Read, MD, MS, MPHf, Megan Valentine, PA-C, MSg, Kasonde Mwinga, MBChB, MMed, MPHh, Robert Goldenberg, MDi and Taha E. Taha, MD, PhDj

a Department of Obstetrics and Gynecology, College of Medicine, University of Malawi, Blantyre, Malawi
b Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington
c Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
d Center for Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina
e Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts
f Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland
g Family Health International, Research Triangle Park, North Carolina
h Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia
i Department of Obstetrics and Gynecology, Drexel University College of Medicine, Philadelphia, Pennsylvania
j Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland

BACKGROUND: Infants born to women who receive intrapartum antibiotics may have higher rates of infectious morbidity and mortality than unexposed infants.

OBJECTIVE: Our goal was to determine the association of maternal intrapartum antibiotics and early neonatal morbidity and mortality.

METHODS: We performed secondary analysis of data from a multisite randomized, placebo-controlled clinical trial of antibiotics to prevent chorioamnionitis-associated mother-to-child transmission of HIV-1 and preterm birth in sub-Saharan Africa. Early neonatal morbidity and mortality were analyzed. In an intention-to-treat (ITT) analysis, infants born to women randomly assigned to antibiotics or placebo were compared. In addition, non-ITT analysis was performed because some women received nonstudy antibiotics for various clinical indications.

RESULTS: Overall, 2659 pregnant women were randomly assigned. Of these, 2466 HIV-1–infected and HIV-1–uninfected women delivered 2413 live born and 84 stillborn infants. In the ITT analysis, there were no significant associations between exposure to antibiotics and early neonatal outcomes. Non-ITT analyses showed more illness at birth (11.2% vs 8.6%, P = .03) and more admissions to the special care infant unit (12.6% vs 9.8%, P = .04) among infants exposed to maternal intrapartum antibiotics than among unexposed infants. Additional analyses revealed greater early neonatal morbidity and mortality among infants of mothers who received nonstudy antibiotics than of mothers who received study antibiotics.

CONCLUSIONS: There is no association between intrapartum exposure to antibiotics and early neonatal morbidity or mortality. The associations observed in non-ITT analyses are most likely the result of women with peripartum illnesses being more likely to receive nonstudy antibiotics.

Key Words: antibiotic resistance • antibiotics • neonatal morbidity • neonatal mortality • neonatal sepsis

Abbreviations: BV—bacterial vaginosis • PROM—prelabor rupture of membranes • SCBU—special care baby unit • MTCT—mother-to-child transmission • HPTN—HIV Prevention Trials Network • ITT—intention to treat • OR—odds ratio • CI—confidence interval

Accepted Mar 6, 2009.


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