Format

Send to:

Choose Destination
See comment in PubMed Commons below
Trials. 2012 Jun 21;13:89. doi: 10.1186/1745-6215-13-89.

Efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection: study protocol for a randomized controlled trial.

Author information

  • 1Department of Obstetrics and Gynaecology, Catholic University of Health Sciences and Allied Science and Bugando Medical Centre, Box 1464, Mwanza, Tanzania.

Abstract

BACKGROUND:

Caesarean section is a commonly performed operation worldwide. It has been found to increase rates of maternal infectious morbidities more than five times when compared to vaginal delivery. Provision of intravenous prophylactic antibiotics 30 to 60 minutes prior to caesarean section has been found to reduce post-caesarean infection tremendously. Many centers recommend provision of a single dose of antibiotics, as repeated doses offer no benefit over a single dose. At Bugando Medical Centre post caesarean infection is among the top five causes of admission at the post-natal ward. Unfortunately, there is no consistent protocol for the administration of antibiotic prophylaxis to patients who are designated for caesarean section. Common practice and generally the clinician's preference are to provide repeated dosages of antibiotic prophylaxis after caesarean section to most of the patients. This study aims to determine the comparative efficacy of a single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post caesarean infection.

METHODS/DESIGN:

The study is an interventional, open-label, two-armed, randomized, single-center study conducted at Bugando Medical Centre Mwanza, Tanzania. It is an ongoing trial for the period of seven months; 490 eligible candidates will be enrolled in the study. Study subjects will be randomly allocated into two study arms; "A" and "B". Candidates in "A" will receive a single dose of gentamicin in combination with metronidazole 30 to 60 minutes prior to the operation and candidates in "B" will receive the same drugs prior to the operation and continue with gentamicin and metronidazole for 24 hours. The two groups will be followed up for a period of one month and assessed for signs and symptoms of surgical site infection. Data will be extracted from a case record form and entered into Epi data3.1 software before being transferred to SPSS version 17.0 for analysis. The absolute difference in proportion of women who develop surgical site infection in the two study arms will be the effectiveness of one regime over the other.

TRIAL REGISTRATION:

Current Controlled Trials ISRCTN44462542.

PMID:
22720689
[PubMed - indexed for MEDLINE]
PMCID:
PMC3475059
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for BioMed Central Icon for PubMed Central
    Loading ...
    Write to the Help Desk