Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2022-02-01

Brief Summary

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In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system.

TXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.

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Detailed Description

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Conditions

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Postpartum Hemorrhage Tranexamic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision

Control group

Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Interventions

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Tranexamic acid

Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision

Intervention Type DRUG

Normal saline

Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All English speaking patients
* Above 21 year old
* Undergoing elective caesarean section.

Exclusion Criteria

* Known/suspected placenta accreta antenatally
* Contraindications to syntocinon and tranexamic acid such as hypersensitivity to these medications
* Known thrombophilia or coagulopathy
* History of thromboembolic events
* Severe cardiac/renal/liver disease
* Poorly controlled hypertension /severe preeclampsia (BP \> 160/100)/eclampsia

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes