Ghana 2007.
Methods | Randomised controlled trial. | |
Participants | 440 women who had advanced labour and delivered vaginally at the 2 district hospitals in the Brong Ahafo region of Ghana were included. Exclusion criteria included any known contraindication to prostaglandin administration (hypersensitivity or medical conditions, including asthma or epilepsy). Women at perceived high risk for postpartum haemorrhage were not excluded, but the factors that increased the risk were recorded on the data sheet. They were as follows: grand multiparity (greater than para 5), multiple gestation, previous postpartum haemorrhage, precipitous labour (less than 3 hours), coagulation abnormality, chorioamnionitis, polyhydramnios, previous caesarean section, and oxytocin induction or augmentation of labour. |
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Interventions | Rectal misoprostol 800 mcg versus IM 10IU oxytocin with the delivery of the anterior shoulder. | |
Outcomes | Primary outcome was the change in haemoglobin from before delivery to after delivery. Other outcomes were estimated blood loss, additional uterotonic use, clinical diagnosis of postpartum haemorrhage, blood transfusion and side‐effects (nausea, vomiting, shivering and temperature > 37.5 C). | |
Notes | Active management of the third stage of labour. A subjective estimate of blood loss was recorded. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only mentions a "random assignment", not clear on how the sequence generation was done. |
Allocation concealment (selection bias) | Low risk | "The next sequentially numbered, opaque, sealed envelope containing a standard data sheet with a random assignment to either the control group (intramuscular oxytocin) or the treatment group (rectal misoprostol) was opened." |
Blinding (performance bias and detection bias) All outcomes | High risk | It was not mentioned in the text, however, the different administration methods of the 2 drugs and no use of placebo suggests that there was no blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 women from the oxytocin group and 6 women from the misoprostol group were excluded from the analysis as hey did not have both pre and post delivery Hb concentration essays recorded. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review were reported. |
Other bias | Low risk | There was no significant difference between the groups regarding baseline characteristics or risk factors for postpartum haemorrhage. |