Topical Tranexamic Acid in Caesarean Section

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to investigate whether topical application of tranexamic acid into the uterine cavity and the surgical site intra-operatively can reduce blood loss and provide better surgical haemostasis in parturients with moderate to high risk for bleeding undergoing caesarean deliveries.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Meng-Li Lee
• Collaborator: Ministry of Health, Malaysia
• Treatments: Pharmaceutical Solutions; Tranexamic Acid

Criteria

Inclusion Criteria:

1. Parturients aged more than 18 years old

2. American Society of Anesthesiologists (ASA) physical status class 1 to 3

3. Parturients planned for caesarean sections (both emergency and elective) under regional anaesthesia

4. Parturients who have increased risks of bleeding during caesarean deliveries as follows:

Moderate Risk for Bleeding

• Induction of labour

• Prolonged labour >12 hours

• Large baby > 4kg

• Pyrexia in labour

• Age > 40 years (not multiparous)

• Obesity (BMI >35)

• Anaemia (Hb < 9g/dl)

• Multigravida

• Previous history of PPH

• Previous scars

High Risk for Bleeding

• Known bleeding disorders (congenital or acquired)

• Multiple pregnancies

• Preeclampsia and pregnancy induced hypertension

• Placenta praevia

• Placenta accreta/increta/percreta

• Placenta abruption

Exclusion Criteria:

1. Parturients who have an urgent/emergency indication for caesarean sections where timing of the operation may be critical in determining the maternal and/or foetal outcomes

2. Patients who are planned for caesarean sections under general anaesthesia

3. Patients who are already clinically bleeding prior to surgery

4. Parturients who received blood transfusion within 48 hours prior to the caesarean section

5. Patients with known allergy to tranexamic acid

6. Patients with clear contraindications for tranexamic acid (e.g. thromboembolic event, history of convulsions)

7. Patients with severe renal failure with creatinine clearance <10