Tiemersma 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
Also:
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Notes |
Setting: Stanger Provincial Hospital in Stanger, KwaZulu‐Natal, South Africa. Dates: February to October 2012 Declaration of interest: not reported Trial funding source: quote: “This study was supported by the Otto Kranendonk Fund of the Netherlands Society for Tropical Medicine and International Health and Drager Medical South Africa (Pty) Ltd. The funding organisations did not participate in the study design, collection, analysis and interpretation of data. They had no participation either in the writing of the report or in the decision to submit the manuscript for publication.” Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Computer generated blocks of 10 participants" |
Allocation concealment (selection bias) | Low risk | Quote: "...sequentially numbered sealed opaque envelopes. Randomisation cards were not reused in case of post‐randomisation exclusion." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The nature of the intervention prevented us from blinding the study." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The nature of the intervention prevented us from blinding the study." Not stated whether assessment postnatally was done by blinded assessors or not. If unblinded, unlikely to have influenced Hb/Hct or non‐subjective measures but may have influenced clinical judgement, e.g. regarding hyperviscosity diagnosis in the intervention. However, no diagnoses were made of this in either group – reduced effect of bias. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 77 out of 181 randomised were excluded (42.5%) because birthweight was > 3 kg. also 7/88 (8%) babies in DCC group excluded because they needed resuscitation and had ECC. None in ECC group were excluded for this. |
Selective reporting (reporting bias) | Unclear risk | Reported data on all primary and secondary objectives mentioned as well as reported non‐significant parameters. However, we have not assessed trial protocol. |
Other bias | Unclear risk | There were no differences between groups with respect to maternal age, maternal nutritional status, HIV‐positivity, Hb, birthweight, gestational age, gender or cord blood values. Not using ITT because they excluded babies in DCC group who got ECC. |