Methods |
Randomisation: randomised by sealed envelopes with the use of a statistical package to generate the sequence of assignment. |
Participants |
Women of at least 31 weeks' gestation. Inclusion criteria included singleton pregnancy, intact membranes, and no concurrent use of magnesium or narcotics. Country: USA, Colorado. 577 women randomised. |
Interventions |
Women randomised to fetal acoustic stimulation group were given acoustic stimulation for 3 seconds with the stimulator placed at the midpoint between the maternal pubic symphysis and umbilicus. Fetal movements were palpated with the other hand at the fundus. Women randomised to control group were given mock stimulation for 3 seconds with the stimulator placed at the midpoint between the maternal pubic symphysis and umbilicus. Fetal movements were palpated with the other hand at the fundus. |
Outcomes |
Primary outcome: positive test as defined by palpation or visualisation of fetal movement only by the tester during a vibroacoustic stimulation.
Other outcome: FHR reactivity. |
Notes |
The vibratory acoustic stimulus was performed using a vibroacoustic stimulator (Corometrics 146 fetal acoustic stimulator). Randomisation was performed after informed consent. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation with the use of a statistical package to generate the sequence of assignment. |
Allocation concealment (selection bias) |
Low risk |
Sealed envelopes. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
By performing the fetal acoustic stimulation test before NST, the tester was blinded to the result of NST. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
For 23 women, outcome data were not available. No further information provided. |
Selective reporting (reporting bias) |
Unclear risk |
No outcomes documented in methods section. |
Other bias |
Low risk |
No evidence of any other form of bias. |