Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis: a randomized controlled trial.

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.

LEVEL OF EVIDENCE:

I.

• Authors: Deirdre J Lyell, Kristin Pullen, Katherine Fuh, A Musa Zamah, Aaron B Caughey, William Benitz, Yasser Y El-Sayed
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 115 Issue 2 Pt 1 Pg. 344-349 (Feb 2010) ISSN: 1873-233X [Electronic] United States
• PMID: 20093909 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Gentamicins

Topics

• Adult
• Anti-Bacterial Agents (administration & dosage)
• Chorioamnionitis (drug therapy)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fetal Membranes, Premature Rupture
• Gentamicins (administration & dosage)
• Humans
• Injections, Intravenous
• Pregnancy
• Pregnancy Trimester, Third