Methods | Selected by randomisation table to receive treatment or no treatment; not blinded or placebo‐controlled. | |
Participants | 393 women undergoing instrumental deliveries (either vacuum or forceps deliveries). Women were excluded if they had evidence of chorioamnionitis, or other infections, or if they were allergic to penicillin or cephalosporins. Setting: University Hospital of Jacksonville, USA; September 1986 to February 1988. | |
Interventions | 2 g of cefotetan intravenously after cord clamping (n = 192) or no treatment (n = 201). | |
Outcomes | Endomyometritis (at least 1 rise in oral temperature greater than 38.1 degrees Celsius after the first 24 hours of delivery and uterine tenderness or foul‐smelling lochia with no clinical or laboratory evidence confirming another source of the fever). | |
Notes | Dates study conducted: the trial was carried out between September 1986 and February 1989. Funding sources for the study: the funding sources of an included study could not be identified. Declarations of interest among primary researchers: not reported. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A randomisation table was used for random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment could not be interpreted. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Information not clearly mentioned. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Who measured the outcome was not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Same number of samples at intervention given and outcome measure. |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available, so there was insufficient information to permit judgement. |
Other bias | Low risk | Study appeared to be free of other sources of bias. |