Iran 2009.
Methods | Open‐label randomised controlled trial. | |
Participants | 100 term pregnant women between 37 and 40 weeks of pregnancy who were candidates for caesarean and underwent general anaesthesia were included. Exclusion criteria included an additional risk for postcaesarean haemorrhage, including: multiple gestation; prolonged labour of more than 12 hours; 2 or more previous caesarean sections; a history of uterine rupture and anaemia‐Hb (8 mg/dL). Also women who had a history of heart, renal or liver disorders or had a coagulopathy were excluded. |
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Interventions | Immediately after delivery, 2 misoprostol tablets (200 mcg) dissolved in 5 cc of distilled water (for better distribution and absorption) and taken sublingually (vs 20 units of oxytocin in 1 litre Ringer lactate at the rate of 10 cc/min was used until full contraction of the uterus). | |
Outcomes | The need for additional oxytocin in surgery, the volume of infusion, need for blood transfusion, drug side‐effects (such as tachycardia, decrease in blood pressure, fever, shivering, headache and metallic taste) or any other significant complications were recorded. | |
Notes | AMTSL not applicable, as this study includes women who had caesarean section only. The blood loss was measured in the suction bottle so that amniotic fluid was first suctioned and measured and then subtracted from the total volume of the suction bottle. The amount of blood on the patients' drapes and pads was measured by weighing them and then subtracting their known dry weight and this value was added to the amount of blood in the suction bottle. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear how the sequence generation was done. |
Allocation concealment (selection bias) | Unclear risk | Unclear how the allocation concealment was done. |
Blinding (performance bias and detection bias) All outcomes | High risk | This was an open‐label trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up or exclusions were mentioned. |
Selective reporting (reporting bias) | Unclear risk | Not all of the primary outcomes of the review were reported. |
Other bias | Low risk | "There were no significant differences in demographic data between the 2 groups in relation to age, weight, gestational age and parity." |