March 2013.
Methods | Randomised controlled trial. Random permuted blocks of 10. | |
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 1: cord intact during UCM |
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Outcomes |
Primary
Secondary
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Notes |
Setting: East Virginia, USA. Single tertiary centre. Dates: September 2009 to June 2011 Declaration of interest: authors declare no conflicts of interest. Trial funding source: this work was conducted with support from Harvard Catalyst. The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award 8UL1TR000170‐05 and financial contributions from the Harvard University and its affiliated academic healthcare centres. Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | ‘An independent statistician provided the randomisation sequence.’ Personal communication with Dr March provided the following information: Quote: “A statistician provided random permuted blocks of 10 using a SAS program." |
Allocation concealment (selection bias) | Low risk | 'Serially numbered opaque envelopes' |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The neonatologists and pediatric support staff were not blinded to treatment assignment given that they were required to be present for the delivery." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The neonatologists and pediatric support staff were not blinded to treatment assignment given that they were required to be present for the delivery....no notation of study participation was made in the neonate’s chart in order to minimize the possibility that postnatal treatment decisions would be influenced by study participation." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 33.6% of women were excluded because they gave birth beyond 28 weeks' gestation. This was 16 in each group and so we believe this is unlikely to cause serious bias but unclear. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Low risk | Baseline characteristics were similar in the groups. Compliance: 1 woman in the cord milking group had the cord inadvertently clamped and cut immediately. This was dealt with by ITT. |