| Methods |
Double blind, RCT; 3 parallel groups. |
|
Unit of randomization: individual. |
| Participants |
Date of data collection: March 1985 - August 1986. |
|
Setting: Mexico. |
|
Inclusion criteria: women undergoing CS (labor < 12 hours, membrane rupture < 12 hours, < 7 vaginal exams) |
|
Exclusion: any antibiotic within 2 weeks, fever, clinical evidence of infection |
| Interventions |
Ampicillin 1 g IV every six hours × 3 then 1 g every 6 hours × 7 days (N = 23) vs ampicillin 1 g every 6 hours × 3 doses then placebo (N = 37) vs placebo (N = 31). Antibiotics administered after surgery, within 2 hours of the procedure |
| Outcomes |
Fever > 38 °C × 2 at least 6 hours apart after first 24 hours; endometritis (temperature > 38 °C, purulent lochia, pain on internal examination); wound infection (increased warmth, size or colour of wound, or purulent secretions); urine infection (dysuria and positive culture) |
| Notes |
Paper was not written in English. |
|
No explanation provided for unequal size groups. |
|
Class of antibiotic: Aminopenicillin (ampicillin). |
|
Subgroups:
type of CS unclear;
after cord clamping.
|
| Risk of bias |
| Item |
Authors’ judgement |
Description |
| Adequate sequence generation? |
Yes |
“…by computerized tables…” |
| Allocation concealment? |
Unclear |
Assignment to treatment group was performed using the computer card which is attached to the file |
|
|
No additional information was provided. |
| Blinding? |
Yes |
Double-blind.matching placebo doses. |
| All outcomes |
|
|
| Incomplete outcome data addressed? |
Unclear |
3 were lost to follow up 3 patients excluded for inadequate follow up (group allocation not provided).and no exclusions were reported. The analysis was ITT with the available data |
| All outcomes |
|
| Free of selective reporting? |
Unclear |
Insufficient information to judge. |
| Free of other bias? |
Unclear |
No information provided on which to make a judgement. |
| Overall low risk of bias? |
No |
Allocation concealment is unclear and no explanation provided for unequal size groups and no explanation provided for unequal size groups |