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The electronic and manual searches were done blind to trial allocation status.
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The attending obstetricians and midwives made all the relevant decisions about the woman's obstetric management but obviously could not be blinded to trial allocation.
Owing to the nature of the intervention and the production of an agenda, it will not be possible to blind health professionals or patients to trial allocation.
All vaginal smears were analyzed by a same pathologist who was blind to the trial allocation arm, to characteristics of the pregnant woman and to outcomes.
Oral cleanliness was reported using a 5-point scale and recorded by examiners blinded to trial group allocation.
Allocation will incorporate randomisation at baseline according to age, sex, HADS score, APACHE II, ICE questionnaire score and trial centre Due to the nature of the trial intervention, the nurses and doctors performing trial intervention cannot be blind to the trial group allocation.
All trial staff and participants were blind to treatment allocation throughout the trial.
However the Trial Statistician and Research Workers responsible for the collection of the assessments will remain blind to treatment allocation during the trial and primary analyses.
The study nurse who was responsible for follow-up measurements remained blind to treatment allocation throughout the trial.
Following receipt of a signed consent form and baseline questionnaire, the BEEP trial administrator will randomise the participant using a computer-generated randomisation schedule provided by the Musculoskeletal Clinical Trials Unit (CTU) at Keele University, password-protected to ensure that research nurses and trial statisticians remain blind to treatment allocation.
All patients, families, clinicians, research personnel and the trial biostatistician were blind to treatment allocation.
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