Methods | Randomised controlled study ‐ block randomisation (block of 4 and 6). Individual women. |
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Participants | Women with high‐risk pregnancies ‐ singletons (IUGR 7%, hypertension 10%, diabetes 11%, prolonged pregnancy 43%, decreased fetal movements 22%). GA > 32 weeks. N = 1360 women. |
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Interventions | Intervention: umbilical artery Doppler:
Comparison: electronic FHR with NST:
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Outcomes |
Primary outcome: incidence of CS for fetal distress in labour (non reassuring FHR). Secondary outcome: total CS, Apgar score 1 and 5 min, the incidence of stillbirth, the presence of meconium, and the incidence of transfer to the NICU with severe neonatal morbidity. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table with a variable block size of 4 and 6. |
Allocation concealment (selection bias) | Unclear risk | Sequentially numbered opaque envelopes although no information as to whether they were sealed. “...envelopes were kept in a locked drawer that was accessible only to the unit clerk. The envelops was opened by the nurse/sonographer in the presence of the patient”. |
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 | Unclear risk | Describe any loss of participants to follow‐up at each data collection point:
Describe any exclusion of participants after randomisation:
Was the analysis ITT?
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Selective reporting (reporting bias) | Unclear risk | All the outcomes have been reported but we have not assessed the trial protocol. |
Other bias | Low risk | If the study was stopped early, explain the reasons:
Describe any baseline in balance:
Describe any differential diagnosis:
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AEDF: absent end diastolic flow AEDV: absent end diastolic velocity
AN: antenatal BPD: bronchopulmonary dysplasia BPP: biophysical profile CS: caesarean section CTG: cardiotocography EDV: end diastolic velocities FHR: fetal heart rate GA: gestational age ITT: intention‐to‐treat IUFD: intrauterine fetal death IUGR: intrauterine growth retardation IVH: intraventricular haemorrhage min: minute NEC: necrotising enterocolitis NICU: neonatal intensive care unit NS: not significant NST: non‐stress test PTL: preterm labour PROM: preterm rupture of membranes RCT: randomised controlled trial RDS: respiratory distress syndrome SD: standard deviation SGA: small‐for‐gestational age US: ultrasound vs: versus