title: Single-dose compared with multiple day antibiotic prophylaxis for cesarean section in low-resource settings, a randomized controlled, noninferiority trial.
abstract: OBJECTIVE
  To investigate the efficacy of a single prophylactic dose of ampicillin combined with metronidazole to prevent postcesarean section infections compared with a multiple day regimen in low-resource settings.
  
  
  METHODS
  An evaluator-blinded randomized, controlled, noninferiority trial.
  
  
  METHODS
  Two rural hospitals in Tanzania.
  
  
  METHODS
  Of 181 enrolled eligible women with an indication for cesarean section, information on 176 was analyzed by intention-to-treat.
  
  
  METHODS
  The women were randomly assigned to either the intervention group who received a single dose of ampicillin and metronidazole, or to the control group who received a multiple-day regimen of ampicillin/amoxicillin and metronidazole.
  
  
  METHODS
  The primary outcome was maternal postcesarean infection. Secondary outcomes were severity of these infections, other maternal complications, and the duration of hospital stay.
  
  
  RESULTS
  In the intervention group (n = 89), six women (6.7%) developed a wound infection compared with nine (10.3%) in the control group (n = 87) (difference 3.60; 95% CI -4.65 to 11.85) (p = 0.40).
  
  
  CONCLUSIONS
  A single dose of prophylactic ampicillin and metronidazole is equally effective as a multiple-day regimen in preventing postcesarean wound infections in low-resource settings, therefore it can be considered as a good strategy in low-resource settings. The reduced quantity of prophylactic antibiotics will reduce costs without increasing the risk of maternal infection.
authors.affiliation: Mkomaindo District Hospital, Masasi, Tanzania; Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands.
authors.forename: Esther H M N
authors.initials: EH
authors.lastname: Westen
authors.forename: Pascal R
authors.initials: PR
authors.lastname: Kolk
authors.forename: Christine L
authors.initials: CL
authors.lastname: van Velzen
authors.forename: Regine
authors.initials: R
authors.lastname: Unkels
authors.forename: Nicholaus S
authors.initials: NS
authors.lastname: Mmuni
authors.forename: Alex D
authors.initials: AD
authors.lastname: Hamisi
authors.forename: Ritha E
authors.initials: RE
authors.lastname: Nakua
authors.forename: Anne L M
authors.initials: AL
authors.lastname: Vlek
authors.forename: Heleen J
authors.initials: HJ
authors.lastname: van Beekhuizen
mesh_terms: D000293:Adolescent; D000328:Adult; D000667:Ampicillin / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D002585:Cesarean Section / Q000009:adverse effects* / Q000379:methods; D016001:Confidence Intervals; D003906:Developing Countries; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016015:Logistic Models; D008795:Metronidazole / Q000008:administration & dosage*; D011247:Pregnancy; D011256:Pregnancy Outcome; D018570:Risk Assessment; D016037:Single-Blind Method; D012959:Socioeconomic Factors; D018709:Statistics, Nonparametric; D013530:Surgical Wound Infection / Q000188:drug therapy / Q000517:prevention & control*; D013636:Tanzania; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D008795:Metronidazole; D000667:Ampicillin
keywords: Antibiotic prophylaxis; Tanzania; ampicillin; cesarean section; infection; low-resource setting; maternal morbidity; metronidazole