Movafegh 2011.
Methods | Randomised controlled trial undertaken in Iran. | |
Participants | 100 women aged 20–40 years with a singleton pregnancy at between 38 weeks + 5 days and 40 weeks’ gestation, who were categorised as class 1 ASA and were scheduled to undergo CS by Pfannenstiel incision under spinal anaesthesia for malpresentation, contracted pelvis, or patient request. Exclusion criteria were previous history of CS or intra‐abdominal surgery; polyhydramniosis, macrosomia, pre‐eclampsia or abnormal placenta; thrombophilia, anaemia, or coagulopathy; cardiovascular, renal, or liver disorders; or contraindication to any drug used in the study protocol. |
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Interventions | Intervention group (N = 50) ‐ 10 mg/kg TA IV in 200 mL of normal saline infused over 10 minutes, 20 minutes before beginning spinal anaesthesia. Control group (N = 50) ‐ 200 mL of normal saline. Following delivery of the placenta both groups received 10 units of oxytocin in 500 mL of normal saline IV over20 minutes. All patients then received 30 units of oxytocin during the first 8 hours postoperatively. A further 10 units of oxytocin was infused in the case of uterine atony. |
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Outcomes | Blood loss intraoperative and 2 hours after surgery (reported separately), the amount of oxytocin administered in units, postoperative haemoglobin, platelets, PT, PTT and their decline. | |
Notes | No side effects in TA group. Blood loss was reported separately during CS and 2 hours after CS. Blood loss included amniotic fluid volume. We have used intraoperative blood loss. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | Low risk | All of the solutions were prepared by an anaesthetist who was not involved in patient management or assessment; both the patients and investigators were blinded to the group assignment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both the patients and investigators were blinded to the group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The investigators were blinded to the group assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete data. |
Selective reporting (reporting bias) | Unclear risk | No prior registration of the protocol. |
Other bias | Low risk | None identified. |