Methods |
Randomized trial
Study period: not given |
Participants |
Inclusion criteria: women treated for chorioamnionitis, postpartum endometritis (defined as temperature of at least 38.1 °C, leukocytosis 15,000/mL, and uterine tenderness), or post hysterectomy cellulitis. All had received standard parenteral antibiotics until 48‐72 hours afebrile and clinically well
Setting: Lexington, Kentucky, USA
Number of participants: n = 163 evaluated, n = 81 with postpartum endometritis |
Interventions |
Oral ampicillin 500 mg every 6 hours or tetracycline 500 mg every 6 hours (if penicillin allergic) to complete 10 days total of antibiotic therapy (n = 38) vs no treatment after iv antibiotics (n = 43) |
Outcomes |
Further treatment with antibiotics by the time of follow up at 2‐4 weeks after hospital discharge
Postdischarge infections (wound or urinary tract infection) classified as failures |
Notes |
Information on route of delivery was not given
Pharmaceutical sponsorship ‐ none apparent |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
States “random” without further description |
Allocation concealment (selection bias) |
Unclear risk |
Not stated |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
States “single‐blinded study” in abstract but no further description |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
“The physician evaluating the patient at the follow‐up examination [..] was blinded as to whether they had taken the oral antibiotic or not:” Outcome assessor was blinded |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
163 (80%) out of 204 women were evaluated. 31 had no follow‐up visits, 10 had infection at other organ sites |
Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgement |
Other bias |
Low risk |
Study appeared to be free of other sources of bias |