search
Back to results

The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section (ETAPPH)

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 3
Locations
Zimbabwe
Study Type
Interventional
Intervention
Tranexamic acid injection
Normal saline placebo
Sponsored by
University of Zimbabwe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Postpartum hemorrhage, Tranexamic acid, Caesarean section, Prevent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women undergoing elective or emergency caesarean section with:

  • Estimated gestational age of 37 weeks or more
  • Live intrauterine foetus
  • Elective or emergency caesarean delivery
  • Signed informed consent

Exclusion Criteria:

  • History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
  • seizure history,
  • autoimmune disease,
  • placental abruption,
  • placenta praevia,
  • abnormally adherent placentae if identified on prenatal ultrasound,
  • eclampsia or HELLP syndrome,
  • known hypersensitivity to TXA,
  • planned general anaesthesia,
  • caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,
  • poor understanding of English/Shona languages,
  • those who have received anticoagulants in the week before delivery
  • persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women

Sites / Locations

  • Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
  • Sally Mugabe Central Hospital Maternity Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group/Group A

Control group/Group B

Arm Description

The study group will receive TXA 1g intravenously at the onset of skin incision.

There is an equivalent volume of normal saline for the control group.

Outcomes

Primary Outcome Measures

Number of Participants With Postpartum Hemorrhage (PPH)
Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.

Secondary Outcome Measures

Blood Loss Using Hemoglobin Values
Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Mean Blood Loss as Estimated by Obstetrician
Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
Occurrence of Postpartum Shock
Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Use of Supplementary Uterotonic(s)
Number of women requiring supplementary uterotonics
Postpartum Transfusion
Number of women given postpartum transfusion
Emergency Surgery for PPH
Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Change in Peripartum Haemoglobin
Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Number of Participants With a Decrease in Peripartum Hemoglobin
Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL
Change in Peripartum Haematocrit
Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Admission Into Intensive Care Unit
Number of participants transferred to intensive care unit
Death From Any Cause
Number of participants who died from any cause
Blood Pressure Measurements
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Number of Mild Adverse Events
Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Number of Severe Adverse Events
Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound) Pulmonary embolism (if the diagnosis is confirmed by radiological examination) Myocardial infarction Seizure Renal failure requiring dialysis
Any Other Unexpected Adverse Event
Number of unexpected events during and after the adminstration of study drug and duration of observation
Length of Hospital Stay
Duration of hospital admission in days

Full Information

First Posted
January 16, 2021
Last Updated
February 21, 2023
Sponsor
University of Zimbabwe
Collaborators
Fogarty International Center of the National Institute of Health
search

1. Study Identification

Unique Protocol Identification Number
NCT04733157
Brief Title
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Acronym
ETAPPH
Official Title
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zimbabwe
Collaborators
Fogarty International Center of the National Institute of Health

4. Oversight

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

5. Study Description

Brief Summary
This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.
Detailed Description
This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Postpartum hemorrhage, Tranexamic acid, Caesarean section, Prevent

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group/Group A
Arm Type
Experimental
Arm Description
The study group will receive TXA 1g intravenously at the onset of skin incision.
Arm Title
Control group/Group B
Arm Type
Placebo Comparator
Arm Description
There is an equivalent volume of normal saline for the control group.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
TXA
Intervention Description
Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section
Intervention Type
Other
Intervention Name(s)
Normal saline placebo
Intervention Description
10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group
Primary Outcome Measure Information:
Title
Number of Participants With Postpartum Hemorrhage (PPH)
Description
Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.
Time Frame
Up to day 2 postpartum
Secondary Outcome Measure Information:
Title
Blood Loss Using Hemoglobin Values
Description
Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Time Frame
Up to day 2 postpartum
Title
Mean Blood Loss as Estimated by Obstetrician
Description
Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
Time Frame
2 hours
Title
Occurrence of Postpartum Shock
Description
Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Time Frame
Up to day 2 postpartum
Title
Use of Supplementary Uterotonic(s)
Description
Number of women requiring supplementary uterotonics
Time Frame
Up to day 2 postpartum
Title
Postpartum Transfusion
Description
Number of women given postpartum transfusion
Time Frame
Up to day 2 postpartum
Title
Emergency Surgery for PPH
Description
Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Time Frame
Up to day 2 postpartum
Title
Change in Peripartum Haemoglobin
Description
Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Time Frame
Up to day 2 postpartum
Title
Number of Participants With a Decrease in Peripartum Hemoglobin
Description
Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL
Time Frame
Up to day 2 postpartum
Title
Change in Peripartum Haematocrit
Description
Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Time Frame
Up to day 2 postpartum
Title
Admission Into Intensive Care Unit
Description
Number of participants transferred to intensive care unit
Time Frame
Up to day 2 postpartum
Title
Death From Any Cause
Description
Number of participants who died from any cause
Time Frame
Up to date of death or day 4 from admission
Title
Blood Pressure Measurements
Description
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Time Frame
Up to 2 hours after the caesarean section
Title
Number of Mild Adverse Events
Description
Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Time Frame
Up to 24 hours after administration
Title
Number of Severe Adverse Events
Description
Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound) Pulmonary embolism (if the diagnosis is confirmed by radiological examination) Myocardial infarction Seizure Renal failure requiring dialysis
Time Frame
Up to day 3 postpartum
Title
Any Other Unexpected Adverse Event
Description
Number of unexpected events during and after the adminstration of study drug and duration of observation
Time Frame
Up to day 3 postpartum
Title
Length of Hospital Stay
Description
Duration of hospital admission in days
Time Frame
Up to day 3 postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing elective or emergency caesarean section with: Estimated gestational age of 37 weeks or more Live intrauterine foetus Elective or emergency caesarean delivery Signed informed consent Exclusion Criteria: History of coagulopathies or conditions predisposing them to thromboembolic phenomena, seizure history, autoimmune disease, placental abruption, placenta praevia, abnormally adherent placentae if identified on prenatal ultrasound, eclampsia or HELLP syndrome, known hypersensitivity to TXA, planned general anaesthesia, caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin, poor understanding of English/Shona languages, those who have received anticoagulants in the week before delivery persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chipo Gwanzura, MD
Organizational Affiliation
University of Zimbabwe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
City
Harare
Country
Zimbabwe
Facility Name
Sally Mugabe Central Hospital Maternity Unit
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make individual patient data (IPD) available.

Learn more about this trial

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

We'll reach out to this number within 24 hrs