Blum 2010.
Methods | Computer‐generated random allocation sequence in blocks of 10. Sealed and numbered opaque boxes contained the treatment allocation and were opened in strict numerical sequence Participants received simultaneously either 40 IU oxytocin in a litre of intravenous solution over 15 minutes or 800 mcg (4 tablets of 200 mcg) misoprostol placed under the tongue for 20 minutes and a placebo for the other treatment (i.e. 4 placebo pills or an ampoule of saline). | |
Participants | 809 women diagnosed with PPH due to uterine atony were randomly assigned to receive 800 mcg misoprostol or 40 IU intravenous oxytocin. Diagnosis of PPH was based on need for treatment, as determined by clinical judgement or measured blood loss of 700 mL in the first hour after delivery, whichever occurred first. Women were excluded if their PPH was suspected to have a cause other than uterine atony, if oxytocin was not received during the third stage of labour or if delivery was by caesarean section. |
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Interventions | Prophylactic oxytocin given during the third stage of labour plus 800 mcg misoprostol sublingually or 40 IU intravenous oxytocin after diagnosis of PPH due to uterine atony. | |
Outcomes | Primary outcome: cessation of active bleeding within 20 minutes and additional blood loss of 300 mL or more after treatment. Secondary outcomes: total blood loss after treatment, change in haemoglobin after treatment, time to active bleeding cessation, provision of any additional interventions and side effects. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random allocation sequence in blocks of 10. |
Allocation concealment (selection bias) | Low risk | Allocation sequence was not revealed until data collection and cleaning were completed. Periodic monitoring to ensure hospitals were following the numerical sequence of the boxes. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants received simultaneously either 40 IU oxytocin in a litre of intravenous solution over 15 minutes or 800 mcg (4 tablets of 200 mcg) misoprostol placed under the tongue for 20 minutes and a placebo for the other treatment (i.e. 4 placebo pills or an ampoule of saline). Periodic monitoring of hospitals to ensure masking was successful. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% outcome data. |
Selective reporting (reporting bias) | Low risk | Prior registration of protocol. |
Other bias | Unclear risk | Outcome measure of additional blood loss of 300 mL or more after treatment may have included blood from episiotomy and other liquids collected during delivery. |