Ranjit 2015.
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 3: mixed gestation Comparison 2 DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type intervention) Subgroup 5: DCC at > 2 mins with baby level with uterus and placenta |
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Outcomes |
Primary
Secondary
Definitions
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Notes |
Setting: tertiary care hospital in South India Dates: May 2010 to November 2010 Declaration of interest: no conflict of interest. Trial funding source: quote: "Role of funding source ‐ None" Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Qquote: “…based on computer generated random numbers.” |
Allocation concealment (selection bias) | Low risk | Quote: “Allocation concealment was achieved by sequentially numbered opaque sealed envelopes containing the codes for intervention” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not possible to blind clinicians nor women. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There is no information as to whether there was any attempt to blind outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6 babies (12%) randomised to DCC group were excluded from the study as they did not receive the intervention due to the need for resuscitation. None were excluded from the ECC group, yet 5 died in the ECC group and no deaths were reported in the DCC group, but there is no information on the 6 who were excluded ‐ it is important to know how many of these died. 4 in the ECC group and 3 in the DCC group were lost for follow‐up. Total exclusion DCC 9/50 (18%) ICC 4/50 (8%). Overall 13% exclusions, but uneven. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Unclear risk | Baseline characteristics were similar but they excluded 6 babies from DCC because they needed resuscitation. |