Rabe 2000.
Methods | Randomised controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: 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: Germany Dates: 1997 to 1998 Declaration of interest: none reported Trial funding source: Children's University Hospital of Münster Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The sequencing was computer generated. The allocation was done by a staff member not involved in clinical care or the clinical trial (personal communication). |
Allocation concealment (selection bias) | Low risk | Quote:“by opening a sealed dark envelope”. The sealed dark envelopes were sequentially numbered. The clinician opening the envelope could not predict the allocation (personal communication). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not possible to blind the clinicians at the birth, and it is unclear whether women knew their allocation or not (changed from unclear to high risk). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There was an attempt to blind outcome assessors (group status was not recorded in notes). It was not clear whether lack of blinding affected clinical care or decisions that may have influenced outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 participants were randomised and 39 were included in the analysis. 1 baby in the late clamping group had cord clamping at 30 secs due to clinical concern, and was excluded from the analysis. |
Selective reporting (reporting bias) | Unclear risk | Assessment of bias from published study report. |
Other bias | Low risk | Other bias not apparent. Study groups appeared similar at baseline. |