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

Westen, Esther H.M.N., Kolk, Pascal R., van Velzen, Christine L., Unkels, Regine, Mmuni, Nicholaus S., Hamisi, Alex D., Nakua, Ritha E., Vlek, Anne L.M. and van Beekhuizen, Heleen J. (2015) '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, Vol 94, Issue 1, pp. 43-49.

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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.

Design

An evaluator-blinded randomized, controlled, noninferiority trial.

Setting

Two rural hospitals in Tanzania.

Population

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.

Main outcome measures

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.

Item Type: Article
Subjects: QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 250 Anti-infective agents (General)
WA Public Health > WA 30 Socioeconomic factors in public health (General)
WA Public Health > Health Problems of Special Population Groups > WA 310 Maternal welfare
WQ Obstetrics > Obstetric Surgical Procedures > WQ 430 Cesarean section. Symphysiotomy and similar techniques
WQ Obstetrics > WQ 500 Postnatal care
Faculty: Department: Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI): https://doi.org/10.1111/aogs.12517
Depositing User: Lynn Roberts-Maloney
Date Deposited: 08 Jun 2015 13:14
Last Modified: 06 Feb 2018 13:10
URI: http://archive.lstmed.ac.uk/id/eprint/5200

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