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

February 21, 2023 updated by: Chipo Gwanzura, MD, University of Zimbabwe
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group/Group A
The study group will receive TXA 1g intravenously at the onset of skin incision.
Drug: Tranexamic acid injection
Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section
Other Names:
  • TXA
Placebo Comparator: Control group/Group B
There is an equivalent volume of normal saline for the control group.
Other: Normal saline placebo
10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Postpartum Hemorrhage (PPH)
Time Frame: Up to day 2 postpartum
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.
Up to day 2 postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Loss Using Hemoglobin Values
Time Frame: Up to day 2 postpartum
Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Up to day 2 postpartum
Mean Blood Loss as Estimated by Obstetrician
Time Frame: 2 hours
Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
2 hours
Occurrence of Postpartum Shock
Time Frame: Up to day 2 postpartum
Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Up to day 2 postpartum
Use of Supplementary Uterotonic(s)
Time Frame: Up to day 2 postpartum
Number of women requiring supplementary uterotonics
Up to day 2 postpartum
Postpartum Transfusion
Time Frame: Up to day 2 postpartum
Number of women given postpartum transfusion
Up to day 2 postpartum
Emergency Surgery for PPH
Time Frame: Up to day 2 postpartum
Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Up to day 2 postpartum
Change in Peripartum Haemoglobin
Time Frame: Up to day 2 postpartum
Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Up to day 2 postpartum
Number of Participants With a Decrease in Peripartum Hemoglobin
Time Frame: Up to day 2 postpartum
Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL
Up to day 2 postpartum
Change in Peripartum Haematocrit
Time Frame: Up to day 2 postpartum
Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Up to day 2 postpartum
Admission Into Intensive Care Unit
Time Frame: Up to day 2 postpartum
Number of participants transferred to intensive care unit
Up to day 2 postpartum
Death From Any Cause
Time Frame: Up to date of death or day 4 from admission
Number of participants who died from any cause
Up to date of death or day 4 from admission
Blood Pressure Measurements
Time Frame: Up to 2 hours after the caesarean section
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Up to 2 hours after the caesarean section
Number of Mild Adverse Events
Time Frame: Up to 24 hours after administration
Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Up to 24 hours after administration
Number of Severe Adverse Events
Time Frame: Up to day 3 postpartum
  • 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
Up to day 3 postpartum
Any Other Unexpected Adverse Event
Time Frame: Up to day 3 postpartum
Number of unexpected events during and after the adminstration of study drug and duration of observation
Up to day 3 postpartum
Length of Hospital Stay
Time Frame: Up to day 3 postpartum
Duration of hospital admission in days
Up to day 3 postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zimbabwe

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fogarty International Center of the National Institute of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chipo Gwanzura, MD, University of Zimbabwe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETAPPH
  • D43TW009343 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not yet known if there will be a plan to make individual patient data (IPD) available.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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