Althabe 2009.
Methods | The study was an individually randomised superiority trial. Women who agreed to participate provided written informed consent and were randomised into 1 of 2 intervention groups when vaginal delivery was imminent. The randomisation was stratified by hospital. 204 women were randomised, 103 allocated to the controlled cord traction group and 101 to the hands‐off group | |
Participants |
Inclusion criteria: women with imminent vaginal delivery in Montevideo & Uruguay public hospital: hospital de clinicas; from 30 December 2006 to September 18 2007; and Hospital Pereire Rossel from 29 June 2007 to 26 October 2007 Age of 18 years and older Single, term baby No contraindication to prophylactic oxytocin Exclusion criteria: severe acute complications (eclampsia and haemorrhage) that were present in labour and that required emergency action |
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Interventions |
Intervention: controlled cord traction Comparison: hands‐off |
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Outcomes |
Primary outcomes(s): blood loss during the third stage of labour. Blood was collected with a purpose designed plastic drape placed under the woman for 20 minutes or until bleeding stopped or she was transferred to another ward. Blood volume was measured by weighing the drape Secondary outcome(s): postpartum haemorrhage greater than or equal to 500 mL Postpartum haemorrhage greater than or equal to 1000 mL Length of the third stage of labour Use of additional uterotonics Need for manual removal of the placenta Uterine curettage or other therapeutic manoeuvres |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generated at the co‐ordinating centre using computer‐generated list of numbers with randomly permuted blocks of 4‐6 in a 1:1 ratio |
Allocation concealment (selection bias) | Low risk | Use of sequentially numbered opaque sealed envelops. When a woman is about to deliver, next numbered envelope was opened |
Blinding of participants and personnel (performance bias) All outcomes | High risk |
Participant:not blinded Clinician: not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessor: not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 5 women not included in analysis |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting |
Other bias | Low risk | No other source of bias identified |