Evidence map›Paper›PMID 22720689›Full record

Trial reportTrials2012

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.

Fadhili M Lyimo, Anthony N Massinde, Benson R Kidenya, Evelyne Konje, Stephen E Mshana

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Fadhili M LyimoDepartment of Obstetrics and Gynaecology, Catholic University of Health Sciences and Allied Science and Bugando Medical Centre, Box 1464, Mwanza, Tanzania.
Anthony N Massinde
Benson R Kidenya
Evelyne Konje
Stephen E Mshana
Catholic University of Health and Allied Sciences · TZBugando Medical Centre · TZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCaesarean 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/

designThe 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 registrationCurrent Controlled Trials ISRCTN44462542.

Indexed as

Research DesignAnti-Bacterial AgentsAntibiotic ProphylaxisCesarean SectionDrug Administration ScheduleDrug Therapy, CombinationFemaleGentamicinsHumansMetronidazolePregnancySurgical Wound InfectionTanzaniaTime FactorsTreatment OutcomeAnti-Bacterial AgentsGentamicinsMetronidazole

Identifiers

PMID22720689
PMCPMC3475059
OpenAlexW2150873492

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.