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. 2015 Sep 12;2015(9):CD007863. doi: 10.1002/14651858.CD007863.pub4

Bracero 1999.

Methods RCT, randomised in blocks of 10.
Participants 410 women referred for antenatal monitoring because of concerns of increased risk.
Interventions Intervention: computerised CTG (N = 205).
Control: traditional CTG (visual analysis) (N = 205).
Outcomes PNM; gestational age at birth; birthweight; Apgar scores; length NICU stay.
Notes Subgroups: increased risk/singletons or multiples/mixed gestation at trial entry.
Outcomes not specified in the review protocol: PNM excluding congenital malformations; PN morbidity as defined by authors; Apgar < 7 at 1 minute; number of babies in NICU for > 2 days; length hospital stay (antenatal or for birth and postnatal not specified); number of surveillance tests antenatally.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "...computer‐generated random table of random numbers..."
Allocation concealment (selection bias) Low risk "...the group assignment was placed in opaque envelopes. The indication for performing FHR monitoring was documented for each participant."   Although not specific that the order the envelopes were opened could not be changed, it would seem that allocation concealment was adequate.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Women did not know which group they were in because as the same Sonicaid was used but the computer function turned off for the control group. However, clinicians knew as they used the findings to make decision. There could be bias for a number of outcomes here.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Clinicians were aware of group assignment. Blinding of outcomes assessors not described. Lack of blinding could have introduced bias for a number of outcomes.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5 of the babies who died were excluded because of congenital abnormalities, 1 from the computerised group and 4 from the traditional group. We have added these back so the analysis is by randomised groups and so ITT.
Selective reporting (reporting bias) High risk We have not assessed the trial protocol but in addition the authors were to report on CS for fetal distress and did not do so.
Other bias Low risk Groups were similar with respect to age, ethnicity, gravidity, and fetal sex. Also similar in primary indication for FH monitoring. There were no obvious other biases.