Postpartum HemorrhagePhase 3ETAPPHNCT04733157
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
A Phase 3 study testing Tranexamic acid injection in people with Postpartum Hemorrhage, run by University of Zimbabwe at 2 sites in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,226 participants
- Where
- 2 sitesZimbabwe
- Study dates
- 23 Mar 2021to 14 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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,
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Zimbabwe2 sites
Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
Harare
Sally Mugabe Central Hospital Maternity Unit
Harare
About this study
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.
Read the 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. .
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic acid injection, Normal saline placebo
- Keywords
- Postpartum hemorrhage, Tranexamic acid, Caesarean section, Prevent
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called TXA
Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section
Normal saline placeboOther
10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group
| Study group | Role | What they receive |
|---|---|---|
| Study group/Group A | Experimental | The study group will receive TXA 1g intravenously at the onset of skin incision. Receives: Drug: Tranexamic acid injection |
| Control group/Group B | Placebo comparator | There is an equivalent volume of normal saline for the control group. Receives: Other: Normal saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 2 postpartum
Secondary outcomes (16)
Blood Loss Using Hemoglobin Values
Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Measured: Up to day 2 postpartum
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.
Measured: 2 hours
Occurrence of Postpartum Shock
Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Measured: Up to day 2 postpartum
Use of Supplementary Uterotonic(s)
Number of women requiring supplementary uterotonics
Measured: Up to day 2 postpartum
Postpartum Transfusion
Number of women given postpartum transfusion
Measured: Up to day 2 postpartum
Emergency Surgery for PPH
Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Measured: Up to day 2 postpartum
Change in Peripartum Haemoglobin
Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Measured: Up to day 2 postpartum
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
Measured: Up to day 2 postpartum
Change in Peripartum Haematocrit
Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Measured: Up to day 2 postpartum
Admission Into Intensive Care Unit
Number of participants transferred to intensive care unit
Measured: Up to day 2 postpartum
Death From Any Cause
Number of participants who died from any cause
Measured: Up to date of death or day 4 from admission
Blood Pressure Measurements
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Measured: Up to 2 hours after the caesarean section
Number of Mild Adverse Events
Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Measured: Up to 24 hours after administration
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
Measured: Up to day 3 postpartum
Any Other Unexpected Adverse Event
Number of unexpected events during and after the adminstration of study drug and duration of observation
Measured: Up to day 3 postpartum
Length of Hospital Stay
Duration of hospital admission in days
Measured: Up to day 3 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start23 Mar 2021
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Chipo Gwanzura, MD, University of Zimbabwe
- Investigators
- Chipo Gwanzura, MD, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733157
- Sponsor's protocol ID
- ETAPPH
- Other IDs
- D43TW009343
- Acronym
- ETAPPH
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2021
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make individual patient data (IPD) available.
Publications
Gwanzura C, Gavi S, Mangiza M, Moyo FV, Lohman MC, Nhemachena T, Chipato T. Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section. BMC Anesthesiol. 2023 Apr 27;23(1):142. doi: 10.1186/s12871-023-02098-w.
PubMed 37106343
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
- ClinicalTrials.gov ID
- NCT04733157
- Acronym / sponsor ID
- ETAPPH / ETAPPH
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Tranexamic acid, Caesarean section, Prevent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,226 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group/Group A | Experimental | Drug: Tranexamic acid injectionThe study group will receive TXA 1g intravenously at the onset of skin incision. |
| Control group/Group B | Placebo comparator | Other: Normal saline placeboThere is an equivalent volume of normal saline for the control group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
- seizure history,
- autoimmune disease,
- placental abruption,
- placenta praevia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionAlso: TXATranexamic 1g administered intravenously at the onset of skin incision at caesarean section | Drug | Study group/Group A |
| Normal saline placebo10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group | Other | Control group/Group B |
Primary outcome
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.
16 secondary outcomes
Blood Loss Using Hemoglobin Values
Time frame: Up to day 2 postpartum
Mean Blood Loss as Estimated by Obstetrician
Time frame: 2 hours
Occurrence of Postpartum Shock
Time frame: Up to day 2 postpartum
Use of Supplementary Uterotonic(s)
Time frame: Up to day 2 postpartum
Postpartum Transfusion
Time frame: Up to day 2 postpartum
Emergency Surgery for PPH
Time frame: Up to day 2 postpartum
Change in Peripartum Haemoglobin
Time frame: Up to day 2 postpartum
Number of Participants With a Decrease in Peripartum Hemoglobin
Time frame: Up to day 2 postpartum
Change in Peripartum Haematocrit
Time frame: Up to day 2 postpartum
Admission Into Intensive Care Unit
Time frame: Up to day 2 postpartum
Death From Any Cause
Time frame: Up to date of death or day 4 from admission
Blood Pressure Measurements
Time frame: Up to 2 hours after the caesarean section
Number of Mild Adverse Events
Time frame: Up to 24 hours after administration
Number of Severe Adverse Events
Time frame: Up to day 3 postpartum
Any Other Unexpected Adverse Event
Time frame: Up to day 3 postpartum
Length of Hospital Stay
Time frame: Up to day 3 postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37106343Gwanzura C, Gavi S, Mangiza M, Moyo FV, Lohman MC, Nhemachena T, Chipato T. Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section. BMC Anesthesiol. 2023 Apr 27;23(1):142. doi: 10.1186/s12871-023-02098-w.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make individual patient data (IPD) available.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chipo Gwanzura, MD principal investigator
University of Zimbabwe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid injection in people with Postpartum Hemorrhage, run by University of Zimbabwe at 2 sites in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postpartum Hemorrhage (PPH) (time frame: Up to day 2 postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.