Intrapartum antibiotic exposure and early neonatal, morbidity, and mortality in Africa

George Kafulafula, Anthony Mwatha, Qing Chen Ying, Said Aboud, Francis Martinson, Irving Hoffman, Wafaie Fawzi, Jennifer S. Read, Megan Valentine, Kasonde Mwinga, Robert Goldenberg, Taha E Taha

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalPediatrics
Volume124
Issue number1
DOIs
StatePublished - Jul 2009

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Infant Mortality
Anti-Bacterial Agents
Morbidity
Mothers
HIV-1
Intention to Treat Analysis
Placebos
Infant Care
Chorioamnionitis
Peripartum Period
Africa South of the Sahara
Premature Birth
Pregnant Women
Randomized Controlled Trials
Parturition

Keywords

  • Antibiotic resistance
  • Antibiotics
  • Neonatal morbidity
  • Neonatal mortality
  • Neonatal sepsis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Intrapartum antibiotic exposure and early neonatal, morbidity, and mortality in Africa. / Kafulafula, George; Mwatha, Anthony; Ying, Qing Chen; Aboud, Said; Martinson, Francis; Hoffman, Irving; Fawzi, Wafaie; Read, Jennifer S.; Valentine, Megan; Mwinga, Kasonde; Goldenberg, Robert; Taha, Taha E.

In: Pediatrics, Vol. 124, No. 1, 07.2009.

Research output: Contribution to journalArticle

Kafulafula, G, Mwatha, A, Ying, QC, Aboud, S, Martinson, F, Hoffman, I, Fawzi, W, Read, JS, Valentine, M, Mwinga, K, Goldenberg, R & Taha, TE 2009, 'Intrapartum antibiotic exposure and early neonatal, morbidity, and mortality in Africa', Pediatrics, vol. 124, no. 1. https://doi.org/10.1542/peds.2008-1873
Kafulafula G, Mwatha A, Ying QC, Aboud S, Martinson F, Hoffman I et al. Intrapartum antibiotic exposure and early neonatal, morbidity, and mortality in Africa. Pediatrics. 2009 Jul;124(1). https://doi.org/10.1542/peds.2008-1873
Kafulafula, George ; Mwatha, Anthony ; Ying, Qing Chen ; Aboud, Said ; Martinson, Francis ; Hoffman, Irving ; Fawzi, Wafaie ; Read, Jennifer S. ; Valentine, Megan ; Mwinga, Kasonde ; Goldenberg, Robert ; Taha, Taha E. / Intrapartum antibiotic exposure and early neonatal, morbidity, and mortality in Africa. In: Pediatrics. 2009 ; Vol. 124, No. 1.
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abstract = "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.",
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AU - Mwatha, Anthony

AU - Ying, Qing Chen

AU - Aboud, Said

AU - Martinson, Francis

AU - Hoffman, Irving

AU - Fawzi, Wafaie

AU - Read, Jennifer S.

AU - Valentine, Megan

AU - Mwinga, Kasonde

AU - Goldenberg, Robert

AU - Taha, Taha E

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N2 - 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.

AB - 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.

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KW - Neonatal morbidity

KW - Neonatal mortality

KW - Neonatal sepsis

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