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Merck
  • 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
RESUMEN

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.

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