Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.

The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.

Methods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.

The primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.

Discussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.

This large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Zimbabwe
• Treatments: Oxytocin; Tranexamic Acid

Criteria

Inclusion Criteria:

• Pregnant woman with signed informed consent***

• Understand English and/or Shona

• Estimated gestational age of 38 weeks or older

• Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour

• Live intrauterine fetus

• The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.

Exclusion Criteria:

• Placental Abruption

• Emergency caesarean section

• Current or previous history of significant disease including heart disease, liver, renal disorders

• Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)

• History of epilepsy or seizures

• Autoimmune disease

• Sickle cell disease

• Severe haemorrhagic disease

• Intrauterine fetal demise

• Eclampsia/HELLP syndrome

• Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery