Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis

A randomized controlled trial

Deirdre J. Lyell, Kristin Pullen, Katherine Fuh, A. Musa Zamah, Aaron Caughey, William Benitz, Yasser Y. El-Sayed

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

OBJECTIVE: To assess whether daily gentamicin is as effective as 8-hour gentamicin for the treatment of intrapartum chorioamnionitis. METHODS: Women with a clinical diagnosis of chorioamnionitis between 32 and 42 weeks of gestation were randomly assigned in labor to receive either daily gentamicin (5 mg/kg intravenously (IV), then 2 placebo doses IV after 8 and 16 hours) or 8-hour gentamicin (2 mg/kg IV, then 1.5 mg/kg IV after 8 and 16 hours). Both groups received ampicillin (2 grams IV every 6 hours for a total of four doses). Patients who underwent cesarean delivery also received clindamycin (900 mg IV every 8 hours, for a total of three doses). The primary outcome was treatment success, defined by resolution of chorioamnionitis after 16 hours of treatment without development of endometritis. One hundred twenty-six patients were required to have 95% confidence that daily gentamicin is at worst 15% inferior to 8-hour dosing with an alpha of .05 and a beta of 0.2. Results: One hundred twenty-six women were enrolled, of whom 63 received daily gentamicin and 63 received 8-hour gentamicin. One patient was excluded from data analysis. Baseline maternal and obstetric characteristics were similar between groups except for longer mean duration of ruptured membranes in the 8-hour group (679±514 compared with 469±319 minutes; P =.03). Treatment success was equal between groups (94% daily gentamicin compared with 89% 8-hour gentamicin, P =.53). There were no differences in maternal or neonatal morbidities, including neonatal sepsis and newborn hearing screen. Conclusion: Daily and 8-hour gentamicin appear equally effective for the treatment of intrapartum chorioamnionitis. Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00185991.

Original languageEnglish (US)
Pages (from-to)344-349
Number of pages6
JournalObstetrics and Gynecology
Volume115
Issue number2 PART 1
DOIs
StatePublished - Feb 2010
Externally publishedYes

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Chorioamnionitis
Gentamicins
Randomized Controlled Trials
Therapeutics
Mothers
Endometritis
Clindamycin
Ampicillin
Hearing
Obstetrics
Placebos
Clinical Trials
Newborn Infant
Morbidity

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis : A randomized controlled trial. / Lyell, Deirdre J.; Pullen, Kristin; Fuh, Katherine; Zamah, A. Musa; Caughey, Aaron; Benitz, William; El-Sayed, Yasser Y.

In: Obstetrics and Gynecology, Vol. 115, No. 2 PART 1, 02.2010, p. 344-349.

Research output: Contribution to journalArticle

Lyell, Deirdre J. ; Pullen, Kristin ; Fuh, Katherine ; Zamah, A. Musa ; Caughey, Aaron ; Benitz, William ; El-Sayed, Yasser Y. / Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis : A randomized controlled trial. In: Obstetrics and Gynecology. 2010 ; Vol. 115, No. 2 PART 1. pp. 344-349.
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AB - OBJECTIVE: To assess whether daily gentamicin is as effective as 8-hour gentamicin for the treatment of intrapartum chorioamnionitis. METHODS: Women with a clinical diagnosis of chorioamnionitis between 32 and 42 weeks of gestation were randomly assigned in labor to receive either daily gentamicin (5 mg/kg intravenously (IV), then 2 placebo doses IV after 8 and 16 hours) or 8-hour gentamicin (2 mg/kg IV, then 1.5 mg/kg IV after 8 and 16 hours). Both groups received ampicillin (2 grams IV every 6 hours for a total of four doses). Patients who underwent cesarean delivery also received clindamycin (900 mg IV every 8 hours, for a total of three doses). The primary outcome was treatment success, defined by resolution of chorioamnionitis after 16 hours of treatment without development of endometritis. One hundred twenty-six patients were required to have 95% confidence that daily gentamicin is at worst 15% inferior to 8-hour dosing with an alpha of .05 and a beta of 0.2. Results: One hundred twenty-six women were enrolled, of whom 63 received daily gentamicin and 63 received 8-hour gentamicin. One patient was excluded from data analysis. Baseline maternal and obstetric characteristics were similar between groups except for longer mean duration of ruptured membranes in the 8-hour group (679±514 compared with 469±319 minutes; P =.03). Treatment success was equal between groups (94% daily gentamicin compared with 89% 8-hour gentamicin, P =.53). There were no differences in maternal or neonatal morbidities, including neonatal sepsis and newborn hearing screen. Conclusion: Daily and 8-hour gentamicin appear equally effective for the treatment of intrapartum chorioamnionitis. Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00185991.

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