Methods | “Prospective randomised controlled study.” | |
Participants | “214 singleton high risk pregnancies.” | |
Interventions | “Modified biophysical profile following vibroacoustic stimulation (VAS/mFBP) versus mock stimulation (mFBP).” | |
Outcomes | Data were provided for the subgroup of 28 cases with decreased fetal movements on the following outcomes Primary outcomes
Secondary outcomes
|
|
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer-generated random sequence. |
Allocation concealment (selection bias) | Low risk | Allocation concealment using sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | No indication ofincomplete outcome data. |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Low risk | In the total sample of 214 singleton high-risk pregnancies at the outset of monitoring there were no significant differences between the 2 groups with respect to the maternal age, parity, gestational age and high-risk factors (intrauterine growth retardation, pregnancy-induced hypertension, adverse obstetric history, decreased fetal movements, postdated pregnancy, diabetes mellitus and antepartum haemorrhage) |