Postpartum HemorrhagePhase 3NCT04427618
Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section
A Phase 3 study testing Tranexamic acid and Normal saline in people with Postpartum Hemorrhage and Tranexamic Acid, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Tranexamic Acid
- What is being tested?
- Tranexamic acid and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Jun 2020to 1 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All English speaking patients
- Above 21 year old
- Undergoing elective caesarean section.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial
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.
- Conditions
- Postpartum Hemorrhage, Tranexamic Acid
- Being tested
- Tranexamic acid, Normal saline
- 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 acidDrug
Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
Normal salineDrug
Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Drug: Tranexamic acid |
| Control group | Placebo comparator | Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Secondary outcomes (10)
Change in hemoglobin and hematocrit level
Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery
Measured: Preoperative to 48 hours postoperative
Need for additional medical intervention including blood transfusion, additional uterotonics
Measured: During surgery and up to 3 days after surgery
Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery
Measured: During surgery and up to 24 hours from surgery
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.
Measured: Intraoperative to 4 weeks post surgery
Neonatal APGAR score
Neonatal APGAR score at 1 and 5 minutes of life
Measured: At delivery
Neonatal birth weight
Measured: At delivery
Neonatal admission to special care nursery or intensive care unit
Measured: At delivery
Diagnosis of thromboembolic events in the neonate
Measured: Up to 4 weeks post delivery
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
Measured: Intraoperative
Provider estimated blood loss
Estimated by the surgical team
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start23 Jun 2020
- Primary completion3 Oct 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Manisha Mathur, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427618
- Sponsor's protocol ID
- 2019/2425
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04427618
- Acronym / sponsor ID
- 2019/2425
- Conditions
- Postpartum Hemorrhage, Tranexamic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Tranexamic acidIntravenous 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. |
| Control group | Placebo comparator | Drug: Normal salineIntravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All English speaking patients
- Above 21 year old
- Undergoing elective caesarean section.
Key exclusion criteria (6 listed)
- 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
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 acidIntravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision | Drug | Intervention group |
| Normal salineIntravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision | Drug | Control group |
Primary outcome
Estimated blood loss
Time frame: Intraoperative
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.
10 secondary outcomes
Change in hemoglobin and hematocrit level
Time frame: Preoperative to 48 hours postoperative
Need for additional medical intervention including blood transfusion, additional uterotonics
Time frame: During surgery and up to 3 days after surgery
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
Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism
Time frame: Intraoperative to 4 weeks post surgery
Neonatal APGAR score
Time frame: At delivery
Neonatal birth weight
Time frame: At delivery
Neonatal admission to special care nursery or intensive care unit
Time frame: At delivery
Diagnosis of thromboembolic events in the neonate
Time frame: Up to 4 weeks post delivery
Gravimetric estimation of blood loss during the surgery
Time frame: Intraoperative
Provider estimated blood loss
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: Undecided
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.
Manisha Mathur principal investigator
KK Women's and Children's Hospital
1 site 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 and Normal saline in people with Postpartum Hemorrhage and Tranexamic Acid, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 3 inclusion and 6 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimated blood loss (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.