Methods | Randomised controlled trial. | |
Participants | Outpatients referred for fetal heart monitoring. | |
Interventions | Visual or computerised interpretation of FHR monitoring recording | |
Outcomes | Number of additional fetal surveillance tests, amount of time spent per FHR test, perinatal morbidity and mortality, NICU admission for more than 2 days, and total NICU days. Perinatal morbidity was defined as caesarean delivery for fetal distress, hypocalcaemia (total serum calcium level < 7 mg/dL), hyperbilirubinaemia (indirect bilirubin level > 12 mg/dL), hypoglycaemia (glucose serum level < 30 mg/dL), respiratory distress syndrome, transient tachypnoea, and meconium aspiration | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table. |
Allocation concealment (selection bias) | Low risk | Opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk | Not blinded. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk | Not blinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Five pregnancies were excluded from the outcome analysis because infants were diagnosed with congenital anomalies: four of these appear to be from the visual interpretation group (n=201) and one from the computerised interpretation group (n=204) |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes appear to have been reported upon. |
Other bias | Low risk | “The two randomized groups were similar at baseline, but the computerized interpretation group has significantly fewer biophysical profiles compared with the visual interpretation group” |