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. Author manuscript; available in PMC: 2014 Jun 16.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Apr 18;4:CD009148. doi: 10.1002/14651858.CD009148.pub2
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
  1. Perinatal mortality and severe morbidity.

  2. Caesarean section.


Secondary outcomes
  1. Perinatal mortality.

  2. Components of severe perinatal morbidity (NICU admission > 24 hours, organ failure and encephalopathy).

  3. Labour induction.

  4. Maternal death or severe maternal morbidity.

  5. Components of severe maternal morbidity (ICU admission > 24 hours and organ failure).

  6. Maternal hospital admission > 7 days.

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)