Strengths and Limitations
The strength of the study include the multi-centre and randomisation
design with good power and patient numbers. A limitation of the study
was that it was impossible to blind the allocation to the investigator
or the patient. However, the investigator had no part in observing any
adverse events. The CTGs were interpreted and the need for intervention
determined by the attending clinicians. Hyperstimulation was
specifically defined and recorded by a third party studying the CTGs and
blinded to the patient’s allocated group. The patient also reported
contractions intervals, pain scores, satisfaction scores with validated
standard pain and satisfaction assessment tools to minimize the
potential bias. Allocations were omitted from the database so as to
blind the analyst in order to prevent manipulation.