Deneux‐Tharaux 2012.
Methods | ||
Participants | Included: women 18 years or more, singleton pregnancy, > 35 weeks, planned vaginal delivery Excluded: severe haemostasis disease, placenta praevia, fetal death, multiple gestation, no French spoken |
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Interventions | Controlled cord traction: after birth controlled cord traction was started with a firm uterine contraction without waiting for placental separation. The lower segment was grasped between the thumb and index finger of 1 hand and steady pressure exerted upwards; at the same time the cord was held in the other hand and steady cord traction exerted downwards and backwards, exactly countered by the upwards pressure of the first hand, so that the position of the uterus remained unchanged. If the placenta was not expelled on the first attempt, controlled cord traction was repeated using counter pressure with the next uterine contraction. In the control arm, the attendant awaited the signs of spontaneous placental separation and descent into the lower uterine segment. Once the placenta was separated it was delivered through the mother’s efforts (helped by fundal pressure or soft tension on the cord to facilitate placental expulsion through the vagina if needed). All other aspects of management of the third stage were identical in both arms: intravenous injection of 5 IU oxytocin and clamping and cutting of the cord within two minutes of birth; placement of a graduated (100 mL graduation) collector bag (MVF Merivaara France) just after birth, left in place until the birth attendant judged that bleeding had stopped and that there was no reason to monitor further, 24 and always at least for 15 minutes; and manual removal of the placenta at 30 minutes after birth if not expelled. A blood sample was taken from all women on the second day after delivery to measure haemoglobin level and haematocrit |
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Outcomes | Primary: postpartum haemorrhage, defined by a blood loss of 500 mL, measured with a graduated collector bag. Secondary: measured blood loss 1000 mL at bag removal, mean measured blood loss at 15 minutes after birth (the bag had to be left in place at least 15 minutes to have 1 measure of blood loss at the same time point in all women), mean measured postpartum blood loss at bag removal, and mean changes in peripartum haemoglobin level and haematocrit (difference between haemoglobin level and haematocrit before delivery and at day 2 postpartum). Other secondary outcomes included use of supplementary uterotonic treatment; postpartum transfusion (until discharge); arterial embolisation or emergency surgery for postpartum haemorrhage; other characteristics of the third stage, including duration, manual removal of the placenta; and women’s experience of the third stage, assessed by a self administered questionnaire on day 2 postpartum. Safety outcomes included uterine inversion, cord rupture, and pain |
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Notes | Five French university hospitals between 1 January 2010 and 31 January 2011 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation was stratified by centre and balanced in blocks of 4 |
Allocation concealment (selection bias) | Low risk | Centrally through an automated web‐based system, which ensured allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible, but primary outcome objective measurement of blood loss |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding not possible, but primary outcome objective measurement of blood loss |
Incomplete outcome data (attrition bias) All outcomes | Low risk | After randomisation and before delivery, 294 (6.8%) women became ineligible because an intrapartum caesarean was performed, and three others declined to participate. Women who underwent caesarean section were included in the analysis for outcomes where this was possible |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting |
Other bias | Low risk | No other risk of bias identified |