Switzerland 2006.
Methods | Randomised, double‐blind, placebo‐controlled trial. | |
Participants | 56 pregnant women at low risk for postpartum haemorrhage who underwent indicated or elected caesarean section after the 37th week of pregnancy at the Basel Women's University Hospital in Switzerland. Indications for caesarean section were breech presentation, malposition, IUGR, placenta previa marginalis, twin pregnancy, previous caesarean section, maternal disease and failure of labour to progress. Exclusion criteria included emergency caesarean section within 30 minutes of admission, fetal distress, fetal malformations, preeclampsia or HELLP, hypersensitivity to prostaglandins, coagulopathy, severe systemic disorders, and American Society of Anesthesiologists physical status of 3 or greater, severe asthma, prior myomectomy, and fever (> 38.5 C). |
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Interventions | 800 mcg of oral misoprostol versus 20 IU of oxytocin in saline solution. | |
Outcomes | Outcomes are estimated blood loss (mL), calculated blood loss (mL), Hb level 24 hours postoperatively, g/dL, Hb level 48 hours postoperatively, g/dL, hospital stay (days) and side‐effects (shivering, headache, nausea, flush, diarrhoea). | |
Notes | Active management is not applicable, as the study is limited to caesarean sections. When the membranes had ruptured before the section, the amount of intraoperative and postoperative blood loss was calculated by determining the difference in weight of cloths and pads used to absorb blood during surgery and postoperatively in the intermediate care unit. When the membranes had not ruptured preoperatively, the amount of blood loss was assessed by collecting the blood in suction bottles and subtracting the estimated amniotic fluid volume. It should be noted that all participants received a 5 IU bolus of oxytocin intravenously and afterwards were randomised to receive either of the above medications immediately after cord clamping. This regimen was imposed by the institutional ethics committee as a consequence of the Cochrane Library Review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The hospital pharmacy performed 1:1 computer‐generated randomization that assigned the participants to their group." |
Allocation concealment (selection bias) | Low risk | "The pharmacy also provided the study drugs and placebos in unidentifiable form. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 patients in the oxytocin group were excluded from statistical analysis because of errors in drug administration. |
Selective reporting (reporting bias) | Unclear risk | Not all of the primary outcomes of the review were reported. |
Other bias | Low risk | The demographic and obstetric characteristics are similar between the 2 groups. |