Selzer 2020.
Study characteristics | ||
Methods | RCT | |
Participants | Women undergoing elective CS under spinal anaesthesia (IT morphine) N = 122 women randomised |
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Interventions | Intervention: corticosteroid (Comparison 3)
Group 2: placebo.
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Outcomes | Nausea and vomiting (intra‐ and post‐op), pain, satisfaction. | |
Notes | Setting: New York‐Presbyterian Hospital/Weill Cornell Medicine in New York, NY, USA Dates: November 2012 to September 2014 Funding source: this study was funded by departmental support from the Department of Anesthesiology of Weill Cornell Medicine. There are no additional commercial or non‐commercial affiliations, associations, or sources of funding to disclose. Declaration of interest: authors declared none. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “…a computer‐generated simple (non‐blocked) random number sequence…” |
Allocation concealment (selection bias) | Unclear risk | No information on whether allocation was concealed it just reports: quote: “After randomization, the study drug…or placebo … was prepared by an unblinded investigator who had no further involvement in the study.” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “All subjects, care providers, and data collectors were blinded to allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “All subjects, care providers, and data collectors were blinded to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 122 women were randomised and data from 108 analysed (11% loss of data) |
Selective reporting (reporting bias) | High risk | The method section said data would be collected at 0, 1, 3, 6, 24 and 48 hours, but the results section only reports one overall incidence throughout the 48 hours. It is unclear how this overall data were calculated. |
Other bias | Unclear risk | They excluded women after randomisation if they did not receive the intervention of had a PPH, these women should have still been included, but only amount to 11% loss. It is unclear if there might be other biases. |