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. 2013 Nov 12;2013(11):CD007529. doi: 10.1002/14651858.CD007529.pub3

Neales 1994

Methods 2‐arm randomised controlled study of individual women.
Participants Women of 24 weeks or greater gestation with a singleton pregnancy, and ultrasonic evidence of IUGR (abdominal circumference < on or below 5th centile for gestational age).
N = 467 women.
Interventions Intervention: Doppler ultrasound of umbilical artery revealed, weekly or more often if indicated. Documented in notes. Discussed with registrar.
Comparison: Doppler US weekly but recorded in separate file and not disclosed to clinicians.
Outcomes Obstetric management: gestation at birth, time from enrolment to birth, mode of birth/onset of labour, fetal distress in labour.
Neonatal outcome: perinatal mortality, birthweight, admission to NICU, neonatal outcome.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information other than 'randomised'.
Allocation concealment (selection bias) Unclear risk Sealed envelopes but there is no information as to whether the envelopes were opaque and whether they were distributed in a sequential order.
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Blinding women and/or staff in these trials was not generally feasible.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Blinding women and/or staff in these trials was not generally feasible.
Incomplete outcome data (attrition bias) All outcomes Low risk Describe any loss of participants to follow‐up at each data collection point:   
  • no withdrawals reported.                                                          


Describe any exclusion of participants after randomisation: no exclusion:
  • no withdrawals reported.


Was the analysis ITT? If not have the data been able to be re‐included?
  • ITT as far as able to assess. Not specifically stated as such.

Selective reporting (reporting bias) High risk Not all outcomes available and we have not assessed the trial protocol.
Other bias Unclear risk If the study was stopped early, explain the reasons:
  • not stopped early for benefit, but underpowered due to 'cannot do a large enough study'.