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. |
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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. |
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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. |
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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:
Describe any exclusion of participants after randomisation: no exclusion:
Was the analysis ITT? If not have the data been able to be re‐included?
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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:
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