Methods | Randomised. | |
Participants | 1360 patients. | |
Interventions | Doppler testing versus non-stress testing. | |
Outcomes | Incidence of caesarean delivery for fetal distress, neonatal morbidity | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Consenting patients were assigned randomly.” “Each envelope contained an allocation that had been determined with the use of a random number table with a variable block size of 4 and 6”. |
Allocation concealment (selection bias) | Low risk | “Randomization was performed by opening sequentially numbered opaque envelopes.” “The nurse/sonaographer approached the unit clerk to obtain the next envelope in sequence. Envelopes were kept in a locked drawer that was accessible only to the unit clerk.” |
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 | 16 patients were lost to follow up - reasons not reported. 4 patients were assigned randomly in error and did not have the identified high-risk condition and were removed from further analysis. Analysis occurred for 1340 women out of 1360 enrolled - minimal loss |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes appear to have been fully reported |
Other bias | Low risk | There were no significant differences that were identified in the maternal demographic data - apart from a higher incidence of induction in the Doppler group for abnormal testing (31 women vs 13 women) |
FHR: fetal heart rate
ICU: intensive care unit
NICU: neonatal intensive care unit
VAS/mFBP: vibroacoustic stimulation with mock stimulation