Yehia 2014.
| Methods | Randomised controlled double‐blinded trial. | |
| Participants | 223 women undergoing elective CS. Exclusion criteria ‐ medical disorders in pregnancy, bleeding tendency, risk of thromboembolism, known allergy to TA, antepartum haemorrhage, abnormal site of placenta, macrosomic baby, twin pregnancy, polyhydramnios. |
|
| Interventions | Intervention group ‐ TA 1 g with induction of anaesthesia by slow IV injection over 2 minutes in addition to 10 IU of oxytocin injection after delivery of the baby. Control group ‐ 10 IU of oxytocin injection after delivery of the baby. |
|
| Outcomes | Primary ‐ blood loss during CS after delivery of placenta. Secondary outcomes ‐ vital data during first 2 hours postpartum, vaginal bleeding during 6 hours postpartum, 24 hours postoperative haemoglobin and haematocrit values, need for other surgical measures to stop bleeding (B‐Lynch, uterine artery ligation, internal iliac artery ligation, hysterectomy, transfusion of blood or blood products), maternal and neonatal side effects of medications given. |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation coding tables were used. |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | See below. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Surgeons and investigators were not aware whether patient received TA or not. No placebo was used, therefore, participants were aware of allocation group. However, participants knowledge of the group allocation is unlikely to have influenced the blood loss or other objective outcomes. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Randomisation coding tables were concealed from investigators till the end of the trial. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 women in group 1 and five women in group 2 were excluded from this study (either due to uterine contractions before elective CS or no available suction set in the operative room). |
| Selective reporting (reporting bias) | Unclear risk | No prior registration/publication of the study protocol. |
| Other bias | Low risk | None identified. |
BMI: body mass index CS: caesarean section ICU: intensive care unit INR: international normalised ratio IU: international units IV: intravenously NSAID: non‐steroidal anti‐inflammatory drug PIH: pregnancy‐induced hypertension PPH: postpartum haemorrhage PT: prothrombin time PTT: partial thromboplastin time TA: tranexamic acid