Hosono 2015.
Methods | Randomised controlled trial ‐ multicentre (14 centres) | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: UCM
Comparator: ECC
Additional information
Comparison 7 UCM vs ECC (subgroup by gestation) Subgroup 1: < 32‐34 weeks' gestation Comparison 8 UCM vs ECC (subgroup by type of intervention) Subgroup 2: cord cut before UCM |
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Outcomes |
Primary
Secondary
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Notes |
Setting: Japan in 14 centres Dates: January 2008 to December 2013 Declaration of interest: not reported. Trial funding source: The Ministry of Health, Labour and Welfare Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open – no one is blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | High risk | 203 women recruited but outcomes on 154 only – lost 24%. Also planned to recruit 534 on power calculation but have stopped recruiting based on interim analysis. |
Selective reporting (reporting bias) | High risk | There are many outcomes listed in the trial registration form which are not reported on in the conference abstract. Hopefully they will be reported in the full paper. |
Other bias | High risk | Study quote:“terminated before completion of its planned recruitment of 534 patients based on interim analysis.” Also, conference abstract only so very little information to assess other biases. |