Abdel‐Aleem 2013.
Methods | Randomised controlled trial undertaken in Egypt. | |
Participants | 740 pregnant women with singleton fetus at > 37 weeks' gestation undergoing elective CS were considered potentially eligible for the study. Women were considered ineligible if they had any of the following: history of medical disorders, pre‐eclampsia, antepartum haemorrhage, history of thromboembolic disorders, polyhydramnios, macrosomia, history of sensitivity to TA and taking anticoagulant therapy. | |
Interventions | Intervention group (N = 373) received TA 1 g in 20 mL of 5% glucose, given slowly IV over 10 minutes before the operation commenced. The control group (N = 367) received routine care. All received oxytocin (5 IU IV bolus and 20 IU IV infusion) according to hospital policy or judgement of the surgeon. |
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Outcomes | Primary outcome ‐ mean blood loss (mL) (during operation and for 2 hours after operation). Secondary outcomes ‐ incidence of PPH, cases with postpartum blood loss > 500 mL and > 1000 mL, use of additional uterotonics, use of additional surgical intervention to control PPH, the incidence of mild side effects such as (nausea, vomiting, headache, skin reaction), mean change in haematocrit value, mean change in the haemoglobin value, number of hospital admission days, serious adverse events as thromboembolic event, admission to ICU and state of the patient at discharge. |
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Notes | More women in intervention group had BMI > 30, were anaemic and had longer time of surgery. More women in control group had manual removal of placenta and more women in intervention group had placenta removed by controlled cord traction. Blood loss measurement ‐ blood loss included blood loss during CS and 2 hours following operation determined using calibrated drapes. Amniotic fluid was also included. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Computer‐generated random numbers, however, groups were unequal ‐ women in intervention group had BMI > 30, were anaemic and had longer time of surgery and more women in control group had manual removal of placenta and more women in intervention group had placenta removed by controlled cord traction. |
Allocation concealment (selection bias) | High risk | Women were enrolled in the operating room before induction of anaesthesia by opening the opaque sealed envelopes that were consecutively numbered. See above. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | The injection was given by the anaesthetist as requested by the researcher without knowing the nature of the trial. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The control group did not receive any intervention, there was no placebo used. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The researcher was aware of allocation to the groups. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data on all outcomes complete. |
Selective reporting (reporting bias) | Unclear risk | No protocol was registered prior to the trial. |
Other bias | High risk | 1. Imbalances despite randomisation: Despite high‐quality randomisation and allocation concealment more women in intervention group had BMI > 30, were anaemic and had longer time of surgery and more women in control group had manual removal of placenta and more women in intervention group had placenta removed by controlled cord traction. |