Goswami 2013.
Methods | Randomised controlled trial undertaken in India. | |
Participants | 90 women ASA grade I and II patients, age more than 18 years and anaemic patients with haemoglobin 7‐10 g%, undergoing CS. Exclusion criteria: ASA physical status III and IV; history of coagulopathy or thromboembolism, or both; patients who had received Acenocoumerol or platelet antiaggregant such as aspirin in the week before surgery or non‐steroidal anti inflammatory drugs 2 days before surgery; preoperative plasma creatinine greater than 130 μmol/L; myocardial infarction or chronic arteriopathy or unstable angina in the previous 12 months; mental status preventing them from understanding the study prospectus; renal or hepatic impairment or any hypersensitivity to TA. |
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Interventions | Control group (N = 30) – 5 mL of distilled water in 20 mL of 5% glucose. Group T1 (N = 30) – TA 10 mg/kg in 20 mL of 5% glucose. Group T2 (N = 30) – TA 15 mg/kg in 20 mL of 5% glucose. The drug in all the groups was given IV over 20 minutes before skin incision. |
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Outcomes | Blood loss was measured intraoperatively and postoperatively up to 24 hours, uterine contractility, placental separation, neonatal condition and any side effects; methylergometrine intramuscular ‐ a rescue uterotonic treatment when required; postoperative haemoglobin, haematocrit, serum creatinine, prothrombin time, and INR values were recorded at 24 hours. | |
Notes | This trial included only anaemic women with haemoglobin of 7‐10 g%. We used blood loss during surgery for mean blood loss outcome. We combined 2 intervention groups that received different doses of TA. Definition of PPH is not mentioned in the report. Reported that there was no incidence of PPH in any of the patients. Blood loss ‐ was measured during the surgery. Volume in suction bottle before placental delivery was not included. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "All participants were recruited as a consecutive series to one of the three study groups of 30 patients each." |
Allocation concealment (selection bias) | High risk | Neither the patient nor the investigator was aware of the group assignment. An anaesthetist not related to the study prepared the drug for every patient. It is unclear how the allocated intervention was concealed, as the IV infusion would be visible to all. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Neither the patient nor the investigator was aware of the group assignment. An anaesthetist not related to the study prepared the drug for every patient. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Neither the investigator nor the patient was aware of group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data are complete. |
Selective reporting (reporting bias) | High risk | No pre‐trial public registration of protocol. Although the authors stated that the blood loss was measured during surgery and every 2 hours for 6 hours postoperatively and then 6 hourly for 24 hours the data were presented only on intraoperative blood loss. The authors stated that postoperative blood loss was minimal. |
Other bias | High risk | Definition of PPH not mentioned in the report. Women enrolled were anaemic with haemoglobin 7‐10 g%. It is unclear how the sample size was calculated. The groups were not equal ‐ the duration of CS was longest in group 2. We combined groups that were administered different dosages of TA using above‐described methods. |