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.