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  • Single-dose compared with multiple day antibiotic prophylaxis for cesarean section in low-resource settings, a randomized controlled, noninferiority trial.

Single-dose compared with multiple day antibiotic prophylaxis for cesarean section in low-resource settings, a randomized controlled, noninferiority trial.

Acta obstetricia et gynecologica Scandinavica (2014-09-30)
Esther H M N Westen, Pascal R Kolk, Christine L van Velzen, Regine Unkels, Nicholaus S Mmuni, Alex D Hamisi, Ritha E Nakua, Anne L M Vlek, Heleen J van Beekhuizen
ABSTRACT

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. An evaluator-blinded randomized, controlled, noninferiority trial. Two rural hospitals in Tanzania. Of 181 enrolled eligible women with an indication for cesarean section, information on 176 was analyzed by intention-to-treat. 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. The primary outcome was maternal postcesarean infection. Secondary outcomes were severity of these infections, other maternal complications, and the duration of hospital stay. 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). 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.

MATERIALS
Product Number
Brand
Product Description

Supelco
Metronidazole, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Ampicillin trihydrate, VETRANAL®, analytical standard
Supelco
Metronidazole, VETRANAL®, analytical standard
Sigma-Aldrich
Ampicillin trihydrate, 900-1050 μg/mg anhydrous basis (HPLC)
Supelco
Metronidazole, analytical standard
Sigma-Aldrich
Ampicillin, meets USP testing specifications
Ampicillin trihydrate, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Metronidazole, SAJ first grade, ≥99.0%
Sigma-Aldrich
Metronidazole, BioXtra
Supelco
Ampicillin Trihydrate, Pharmaceutical Secondary Standard; Certified Reference Material
Metronidazole, European Pharmacopoeia (EP) Reference Standard
Supelco
Ampicillin, analytical standard
Sigma-Aldrich
Ampicillin sodium salt, BioXtra, suitable for cell culture
Sigma-Aldrich
Ampicillin, anhydrous, 96.0-102.0% (anhydrous basis)
Ampicillin, anhydrous, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Ampicillin sodium salt, powder or crystals, BioReagent, suitable for cell culture
Sigma-Aldrich
Ampicillin sodium salt
Supelco
Ampicillin Sodium, Pharmaceutical Secondary Standard; Certified Reference Material
USP
Ampicillin, United States Pharmacopeia (USP) Reference Standard