Gai 2004.
Methods | Randomised controlled trial undertaken in 3 centres in China. | |
Participants | 180 primiparas healthy women at term with singleton who underwent CS. | |
Interventions | Intervention group (N = 91) ‐ 1 g (10 mL) of TA diluted in 20 mL 5% glucose given IV slow infusion over 5 minutes 10 minutes before incision. Control (N = 89) ‐ received routine care. |
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Outcomes | Blood loss from placental delivery until 2 hours postpartum, incidence of PPH (blood loss > 400 mL), vital signs, uterine contractility, placental separation, neonatal manifestations, side effects. | |
Notes | No placebo was used. Women in both control and study groups received 10 units of oxytocin IV and 20 units of oxytocin into the intrauterine wall. The same surgical team performed CS in each hospital. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised consecutive numbered chart. |
Allocation concealment (selection bias) | High risk | Control group did not receive any intervention, therefore, allocation was not concealed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open label. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No intervention was administered to control group, therefore, blinding was not possible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The data seem complete. |
Selective reporting (reporting bias) | Unclear risk | No prior public registration of protocol. |
Other bias | High risk | PPH > 400 mL and not conventional > 500 mL. No placebo used. No sample size calculation. |