Mercer 2003.
Methods | Randomised controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: deferred cord clamping (DCC)
Comparator: ECC
Additional information
Comparison 1 DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by gestation) Subgroup 1: < 32‐34 weeks' gestation Comparison 2 DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type intervention) Subgroup 2: DCC at < 1 min with baby low (+ gravity) |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes |
Setting: USA Dates: October 1998 to March 2001 Declaration of interest: not reported Trial funding source:“Sigma Theta Tau, Epsilon Chapter; University of Rhode Island Foundation and College of Nursing”. Further information:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “system of randomly prepared cards in sealed nontransparent envelopes." |
Allocation concealment (selection bias) | Unclear risk | Quote: “system of randomly prepared cards in sealed nontransparent envelopes.” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | For this type of intervention blinding participants and the staff present at delivery to group allocation is not possible. Staff providing care may have modified their behaviour according to randomisation group. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is not clear whether lack of blinding would have had an effect on the outcomes measured. There was an attempt to achieve blinding for some of the outcomes assessed as staff were requested not to record group assignment on case notes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 32 participants were randomised and all appeared to be accounted for in the analysis. 2 babies in the delayed clamping group were not treated according to protocol but they were analysed according to randomisation. |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | Low risk | Groups appeared similar at baseline. Other bias not apparent. |