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

Primary Purpose

Postpartum Hemorrhage, Tranexamic Acid

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Tranexamic acid
Normal saline
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Estimated blood loss
This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.

Secondary Outcome Measures

Change in hemoglobin and hematocrit level
Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery
Need for additional medical intervention including blood transfusion, additional uterotonics
Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery
Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism
Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.
Neonatal APGAR score
Neonatal APGAR score at 1 and 5 minutes of life
Neonatal birth weight
Neonatal admission to special care nursery or intensive care unit
Diagnosis of thromboembolic events in the neonate
Gravimetric estimation of blood loss during the surgery
This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted
Provider estimated blood loss
Estimated by the surgical team

Full Information

First Posted
June 7, 2020
Last Updated
November 6, 2022
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04427618
Brief Title
Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section
Official Title
Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
October 3, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Tranexamic Acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision
Primary Outcome Measure Information:
Title
Estimated blood loss
Description
This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Change in hemoglobin and hematocrit level
Description
Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery
Time Frame
Preoperative to 48 hours postoperative
Title
Need for additional medical intervention including blood transfusion, additional uterotonics
Time Frame
During surgery and up to 3 days after surgery
Title
Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery
Time Frame
During surgery and up to 24 hours from surgery
Title
Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism
Description
Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.
Time Frame
Intraoperative to 4 weeks post surgery
Title
Neonatal APGAR score
Description
Neonatal APGAR score at 1 and 5 minutes of life
Time Frame
At delivery
Title
Neonatal birth weight
Time Frame
At delivery
Title
Neonatal admission to special care nursery or intensive care unit
Time Frame
At delivery
Title
Diagnosis of thromboembolic events in the neonate
Time Frame
Up to 4 weeks post delivery
Title
Gravimetric estimation of blood loss during the surgery
Description
This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted
Time Frame
Intraoperative
Title
Provider estimated blood loss
Description
Estimated by the surgical team
Time Frame
Intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Mathur
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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