Unplanned caesarean delivery Pregnancy and Childbirth
Conditions
Interventions
1. The interventions are:
a) 1 g tranexamic acid (10 ml solution) to be given by slow intravenous injection over 30-60 seconds
OR
b) 10 ml of normal saline to be given by slow intravenous injection ov
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age =18 years old 2. At term (= 37 weeks) 3. Able to fully understand Malay or English 4. Live fetus 5. Emergency/unplanned CS in labour (contractions = 2 in 10 min, cervix = 3 cm)
Exclusion criteria
Exclusion criteria: 1. Clinical indication for tranexamic acid 2. Contraindication to tranexamic acid 3. Known hypersensitivity to tranexamic acid 4. Known placenta previa/placenta accreta spectrum 5. Contraindications to tranexamic acid 6. Suspected current thromboembolic events 7. Known thrombophilia, coagulopathy or severe renal disease 8. History of venous thromboembolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculated total blood loss measured using data collected from hospital laboratory records on preoperative (most recently within 8 days before surgery) and postoperative (closest to day 2 after delivery) haematocrit values | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed using the stated data at one time point: 1. Blood loss = 1000 ml measured using recorded calculated total blood loss 2. Blood transfusion measured using data from hospital records 3. Transfusion of other blood products up to hospital discharge measured using data from hospital records 4. Uterotonic agent other than oxytocin up to hospital discharge measured using data from hospital records 5. Surgical or radiologic intervention up to hospital discharge measured using data from hospital records 6. Open-label use of tranexamic acid up to hospital discharge measured using data from hospital records 7. Acute kidney injury up to hospital discharge measured using data from hospital records 9. Postoperation duration of hospital stay measured using data from hospital records 9. Thromboembolic event, ischemic stroke, or myocardial infarction up to hospital discharge measured using data from hospital records 10. New-onset seizure up to hospital discharge measured using data from hospital records 11. Admission to ICU and indication up to hospital discharge measured using data from hospital records 12. Participant energy level measured using an 11- point 0-10 Numerical Rating Scale at hospital discharge 13. Participant side effects cumulative up to hospital discharge measured using data from the participants on: 13.1. Nausea 13.2. Vomiting 13.3. Dizziness 14. Apgar score at 1 and 5 min measured using data from hospital records 15. Umbilical cord artery blood pH measured using data from hospital records 16. Neonatal intensive care admission and indication up to hospital discharge measured using data from hospital records 17. Neonatal thromboembolism up to hospital discharge measured using data from hospital records | — |
Countries
Malaysia
Contacts
Public ContactShnkari Govindasamy
Outcome results
None listed