Hemorrhage From Placenta Previa, With DeliveryNCT04350645
Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major
A study testing Tranexamic acid injection and Normal Saline 0.9% in people with Hemorrhage From Placenta Previa, With Delivery, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hemorrhage From Placenta Previa, With Delivery
- What is being tested?
- Tranexamic acid injection and Normal Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 24 Mar 2020to 23 Dec 2021
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- all placenta previa major pregnant women
Who cannot join
- Any cardiac disorder or liver disease
- Patient on anticoagulant therapy
- History of allergy to tranexamic acid
- Any contraindication for tranexamic acid
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, 56000
Kah Teik Chew
About this study
Official title: Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major: A Randomized Controlled Study
Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia
Read the detailed description
Tranexamic acid is a promising agent, easy to administer, cheap, and can be added to the other routine management in hospitals deliveries. This study aims to document the efficacy of intravenous tranexamic acid in reducing blood loss during and after caesarean section in placenta praevia major patients and to assess the Hb and platelet change after its administration.
General objective:
To investigate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section for placenta praevia major
Specific objectives:
- To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section.
- To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major
- To examine the effect of tranexamic acid on platelet level for caesarean section for PP major
- To observe the side effects of tranexamic acid
This study will be conducted at University Kebangsaan Malaysia Medical Centre (UKMMC). Patients who meet the inclusion criteria will be invited to participate in the study. Patient will be given the information sheet regarding the study and consent will be taken if agreeable to participate. Patients' demographic data will be recorded.
Patients will be classified randomly into two groups using a computer-generated randomization system (Microsoft Office Excel). The list of randomization will be concealed and numbered on sealed opaque envelopes. Each number will be given a readily prepared 10ml syringe of colourless solution, which could either contain the tranexamic acid or placebo.
Each patient will be assigned a serial identification number. The data will be analysed using the Statistical Package for Social Sciences (SPSS).
- Being tested
- Tranexamic acid injection, Normal Saline 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
1g slow bolus of tranexamic acid over 2 minutes
Normal Saline 0.9%Drug
10mls normal saline 0.9% over 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid group | Active comparator | Tranexamic acid group will receive 1g slow bolus of tranexamic acid over 2 minutes at least 5 minutes before skin incision (at the end of spinal/general anaesthesia) Receives: Drug: Tranexamic acid injection |
| Control group | Placebo comparator | The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid) Receives: Drug: Normal Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
Amount of blood loss in mls
Measured: 24 hours
To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major
changes of haemoglobin level
Measured: 24 hours
Secondary outcomes (1)
To evaluate the side effects of tranexamic acid
platelet count
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start24 Mar 2020
- Primary completion23 Dec 2021 (estimated)
- Study completion23 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage From Placenta Previa, With DeliveryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chew Kah Teik, Universiti Kebangsaan Malaysia Medical Centre
- Investigators
- Kah Teik Chew, Principal investigator, UKM Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350645
- Sponsor's protocol ID
- UKM PPI/1118/JEP-2019-846
- Status last verified
- Jan 2021
- First submitted
- 10 Apr 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04350645
- Acronym / sponsor ID
- UKM PPI/1118/JEP-2019-846
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 23 Dec 2021 (estimated)
- Study completion
- 23 Dec 2021 (estimated)
- First posted
- 17 Apr 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.
Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia
Detailed description
Tranexamic acid is a promising agent, easy to administer, cheap, and can be added to the other routine management in hospitals deliveries. This study aims to document the efficacy of intravenous tranexamic acid in reducing blood loss during and after caesarean section in placenta praevia major patients and to assess the Hb and platelet change after its administration.
General objective:
To investigate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section for placenta praevia major
Specific objectives:
- To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section.
- To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major
- To examine the effect of tranexamic acid on platelet level for caesarean section for PP major
- To observe the side effects of tranexamic acid
This study will be conducted at University Kebangsaan Malaysia Medical Centre (UKMMC). Patients who meet the inclusion criteria will be invited to participate in the study. Patient will be given the information sheet regarding the study and consent will be taken if agreeable to participate. Patients' demographic data will be recorded.
Patients will be classified randomly into two groups using a computer-generated randomization system (Microsoft Office Excel). The list of randomization will be concealed and numbered on sealed opaque envelopes. Each number will be given a readily prepared 10ml syringe of colourless solution, which could either contain the tranexamic acid or placebo.
Each patient will be assigned a serial identification number. The data will be analysed using the Statistical Package for Social Sciences (SPSS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid group | Active comparator | Drug: Tranexamic acid injectionTranexamic acid group will receive 1g slow bolus of tranexamic acid over 2 minutes at least 5 minutes before skin incision (at the end of spinal/general anaesthesia) |
| Control group | Placebo comparator | Drug: Normal Saline 0.9%The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all placenta previa major pregnant women
Key exclusion criteria (4 listed)
- Any cardiac disorder or liver disease
- Patient on anticoagulant therapy
- History of allergy to tranexamic acid
- Any contraindication for tranexamic acid
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 injection1g slow bolus of tranexamic acid over 2 minutes | Drug | Tranexamic acid group |
| Normal Saline 0.9%10mls normal saline 0.9% over 2 minutes | Drug | Control group |
Primary outcome
To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
Time frame: 24 hours
Amount of blood loss in mls
To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major
Time frame: 24 hours
changes of haemoglobin level
1 secondary outcome
To evaluate the side effects of tranexamic acid
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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.
Kah Teik Chew principal investigator
UKM Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection and Normal Saline 0.9% in people with Hemorrhage From Placenta Previa, With Delivery, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jan 2021. 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 Malaysia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kah Teik Chew (+60391455951 ext. 5951, drchewkt@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 12 Jan 2021.