Methods |
RCT, 2 parallel groups. |
|
Unit of randomization: individual. |
|
Participants |
Dates of data collection: Sept 2003 - April 2004. |
|
Setting: New Halfa Teaching Hospital, Eastern Sudan. |
|
Inclusion criteria: planned elective CS (categorized as elective) |
|
Exclusion criteria: antibiotics within 2 weeks; any visible infection; elevated temperature; allergic to antimicrobials; did not wish to participate |
|
Interventions |
Ceftriaxone 1 g IV at anesthetic induction vs no treatment. |
|
Outcomes |
Post-operative febrile morbidity (oral temperature ≥ 38 °C twice at least 4 hours apart after first 24 hours |
|
Post-operative infections (endometritis, wound infection, pelvic abscess, peritonitis, other febrile morbidity (UTI, chest infection, malaria) |
|
2 perinatal deaths: 1 in each group due to respiratory distress and septicaemia due to imperforate anus |
|
Notes |
Developing country. |
|
Class of antimicrobial: third generation cephalosporin. |
|
Subgroups: |
|
elective CS;
before cord clamping.
|
|
Risk of bias |
|
Item |
Authors’ judgement |
Description |
|
Adequate sequence generation? |
Unclear |
“Patients were randomized.” |
|
|
No additional details. |
|
Allocation concealment? |
Unclear |
No information. |
|
Blinding? |
No |
No blinding. |
All outcomes |
|
Not placebo-controlled. |
|
Incomplete outcome data addressed? |
Yes |
No loss of participants to follow up. |
All outcomes |
|
No participant excluded after randomization. |
|
|
ITT analysis. |
|
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
|
Free of other bias? |
Unclear |
“The 2 groups were well matched at enrolment and there were no statistical differences in the admission variables.” |
|
|
There was insufficient other information which to judge. |
|
Overall low risk of bias? |
No |
Very little information provided, particularly around allocation concealment and it appears not placebo controlled |