Methods |
RCT; 4 parallel groups. |
|
Unit of randomization: individual. |
Participants |
Dates of data collection: not reported. |
|
Setting: Letterman Army Medical Center, California; Womack Army Community Hospital, North Carolina |
|
Inclusion criteria: women in active labor or ruptured membranes and at least 1 digital vaginal examination (categorized as non-elective in this review although duration of membrane rupture not stated) |
|
Exclusion criteria: allergy to penicillin or cephalosporin, fever > 37.7°C with suspicion of chorioamnionitis; antibiotic use within 2 weeks |
Interventions |
Cefoxitin 2g IV after clamping the cord, repeated every 6 hours for 48 hours (N = 39) vs uterine and peritoneal lavage with 2 g cefoxitin after delivery of the placenta (N = 42) vs irrigation plus IV therapy (N = 38) vs no therapy (N = 39). The three treatment groups have been combined in this review |
Outcomes |
Febrile morbidity (> 37.9 °C twice 6 hours apart after first 24 hours); endometritis (fever and uterine tenderness); UTI (positive culture); wound infection (including fever, cellulitis and exudate); hospital stay (treatment 4.86 vs control 5.2; variance could not be calculated) |
Notes |
3 episodes of septicemia reported in control group vs none in treatment groups. |
|
No antibiotic reactions reported. |
|
Class of antibiotic: second generation cephalosporin (cefamycin) |
|
Subgroups:
non-elective CS;
after cord clamping.
|
Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Yes |
“Randomized… using a table of random numbers…” |
Allocation concealment? |
No |
“Randomization into 1 of 4 groups was performed by using a table of random numbers,” |
Blinding? |
Unclear |
Not placebo-controlled. |
All outcomes |
|
Clinician was not blinded. |
Incomplete outcome data addressed? |
Yes |
No loss of participants to follow up. |
All outcomes |
|
No participant excluded form the analysis. ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 4 groups were comparable regarding age, parity, gestational age, rupture of membrane, labor, vaginal examination. Insufficient other information to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |