Intervention adherence (CONSORT-NPT item 5d)
Seven papers (19%) reported any form of adherence to the intended
procedure. Of these, six stated that procedural details were documented
by the clinician after the assisted birth; however, it was unclear
whether this information related to details of how the procedure was
undertaken or to maternal and neonatal outcomes following birth. One
paper provided further information: ‘participants in the first
phase were asked for written consent to [video] tape the application
of the Odón device. These tapes were made available to the DSMB for
safety evaluation purposes.’ However, no clarification was provided
about who analysed the videos and the standards to which they were
assessed.
Of the 35 papers with more than one trial group, 24 (69%) stated the
number of women crossing over to another group. In a further eight
(23%), it was unclear whether crossovers had occurred and in the
remaining three (9%) there was no mention of crossovers.