Tranexamic acid to reduce blood loss at unplanned caesarean delivery
| ISRCTN | ISRCTN17814519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17814519 |
- Submission date
- 17/07/2024
- Registration date
- 29/07/2024
- Last edited
- 25/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Caesarean deliveries (births by abdominal operation) are increasing worldwide. Excessive bleeding at caesarean delivery is common and can cause other complications including death. Bleeding is increased at unplanned caesarean deliveries compared to planned. Tranexamic acid was originally used for more than 50 years to treat heavy periods. Tranexamic acid stabilizes blood clots by slowing their breakdown reducing or stopping bleeding. It is effective and safe to use in many situations, such as treatment where major bleeding has occurred or prevention where major bleeding is predicted. Recent studies on tranexamic acid used to prevent major bleeding during caesarean section showed confounding results of benefit or no benefit but it appeared safe. Tranexamic acid given slowly after the baby has been delivered but still within the caesarean may not be effective. There remains a knowledge gap on how long before and also how quickly the tranexamic acid dose should be administered at a caesarean for it to be optimally beneficial. These points on timing and speed of administration are especially important in an unplanned (emergency) caesarean where many care measures need to be performed within a short space of time. The past studies on tranexamic acid are in planned caesarean or a mixture of planned and unplanned caesarean cases. There remains a need for further data to provide support that tranexamic acid given speedily before the operation starts (so is likely to be active in the blood before bleeding begins) reduces bleeding as a result of the surgery.
Who can participate?
Adult patients aged 18 years old and over who are in labour (defined as 2 or more contractions every 10 minutes the neck of the womb opened to at least 3 cm) and have a caesarean delivery decided (emergency or unplanned)
What does the study involve?
After obtaining written informed consent, participants will be randomly allocated to one of the trial interventions by a computer. Neither the patient nor your doctor can choose or is aware of which agent is given. A syringe containing 10 ml colourless solution (containing 1 g tranexamic acid or normal saline) will be given to the care provider for administration within the operating theatre. Standard patient care will be applied throughout the hospital stay from preoperative prophylactic measures to intraoperative and postoperative care for all participants. Within 3 days after the caesarean before hospital discharge, a 3 ml blood sample will be drawn (if one was not already performed for routine post-caesarean care) and sent to the hospital laboratory for a complete blood count. This result will be taken together with the blood count routinely taken for women admitted for birth to calculate blood loss at caesarean. Before discharge participants will be asked to rate their energy level using a 0 to 10 rating scale. In all other respects, routine care will be provided to all participants.
What are the possible benefits and risks of participating?
Participants should not expect any benefit as it is not fully established whether tranexamic acid will reduce, or have no effect on blood loss during an emergency caesarean section. However, it is anticipated that blood loss will be reduced but the reduction may or may not be sufficient to minimise further complications like the need for blood transfusion. The investigators plan to publish the findings of this study in a high-impact research journal to help guide care during caesarean section and; hopefully, to show that tranexamic acid can safely reduce blood loss at an unplanned caesarean delivery. A research publication output is an achievement that may enhance career prospects.
Participants should not expect major harm as tranexamic acid has a good and long safety record in a variety of clinical settings. Hypothetically though, tranexamic acid may increase the risk of complications related to blood clots in leg veins or the lungs though increased risk has been demonstrated after many years of use and extensive research on this type of risk. Significant allergic reactions to tranexamic acid are rare. The investigators do not have a monetary or other material stake involved whatever the outcome of this study.
Where is the study run from?
University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
September 2023 to January 2025
Who is funding the study?
Department of Obstetrics and Gynaecology, Faculty of Medicine, University Malaya, (Malaysia)
Who is the main contact?
Dr Shnkari Govindasamy, g.shnkari@ummc.edu.my
Contact information
Public, Scientific, Principal Investigator
Lembah Pantai
Wilayah Persekutuan Kuala Lumpur
59100
Malaysia
| Phone | +601137066166 |
|---|---|
| g.shnkari@ummc.edu.my |
Study information
| Study design | Single-center interventional randomized double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Prophylactic tranexamic on blood loss at uplanned caesarean section delivery: a double-blind randomised trial |
| Study objectives | Tranexamic acid will reduce blood loss at unplanned caesarean delivery |
| Ethics approval(s) |
Approved 26/06/2024, Medical Research Ethics Committee, University of Malaya Medical Centre (Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia; +60379492030; ummc-mrec@ummc.edu.my), ref: 2023922-12898 |
| Health condition(s) or problem(s) studied | Unplanned caesarean delivery |
| Intervention | 1. The interventions are: a) 1 g tranexamic acid (10 ml solution) to be given by slow intravenous injection over 30-60 seconds OR b) 10 ml of normal saline to be given by slow intravenous injection over 30-60 seconds To be administered as soon as possible after entry to the operating theatre After obtaining written informed consent, participants will be randomized to the one of the trial interventions by the opening of a numbered, sealed and opaque envelope (lowest numbered envelope remaining to the newest recruit). A syringe containing 10 ml colourless solution (containing 1 g tranexamic acid or normal saline) will be given to the care provider for administration within the operating theatre. Participants and care providers are masked to the agent allocated. Standard patient care will be applied throughout the hospital stay from preoperative prophylactic measures to intraoperative and postoperative care to all participants. Within 3 days of the caesarean before hospital discharge, a 3 ml blood sample will be drawn (if one was not already performed for the purpose of routine post- caesarean care) and sent to the hospital laboratory for a complete blood count. This result will be taken together with the blood count routinely taken for women admitted for birth to calculate blood loss at caesarean. Prior to discharge participants will be asked to rate their energy level using a 0 to 10 rating scale. In all other respects, routine care will be provided to all participants. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tranexamic acid |
| Primary outcome measure | Calculated total blood loss measured using data collected from hospital laboratory records on preoperative (most recently within 8 days before surgery) and postoperative (closest to day 2 after delivery) haematocrit values |
| Secondary outcome measures | The following secondary outcome measures are assessed using the stated data at one time point: 1. Blood loss ≥ 1000 ml measured using recorded calculated total blood loss 2. Blood transfusion measured using data from hospital records 3. Transfusion of other blood products up to hospital discharge measured using data from hospital records 4. Uterotonic agent other than oxytocin up to hospital discharge measured using data from hospital records 5. Surgical or radiologic intervention up to hospital discharge measured using data from hospital records 6. Open-label use of tranexamic acid up to hospital discharge measured using data from hospital records 7. Acute kidney injury up to hospital discharge measured using data from hospital records 9. Postoperation duration of hospital stay measured using data from hospital records 9. Thromboembolic event, ischemic stroke, or myocardial infarction up to hospital discharge measured using data from hospital records 10. New-onset seizure up to hospital discharge measured using data from hospital records 11. Admission to ICU and indication up to hospital discharge measured using data from hospital records 12. Participant energy level measured using an 11- point 0-10 Numerical Rating Scale at hospital discharge 13. Participant side effects cumulative up to hospital discharge measured using data from the participants on: 13.1. Nausea 13.2. Vomiting 13.3. Dizziness 14. Apgar score at 1 and 5 min measured using data from hospital records 15. Umbilical cord artery blood pH measured using data from hospital records 16. Neonatal intensive care admission and indication up to hospital discharge measured using data from hospital records 17. Neonatal thromboembolism up to hospital discharge measured using data from hospital records |
| Overall study start date | 22/09/2023 |
| Completion date | 01/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 322 |
| Key inclusion criteria | 1. Age ≥18 years old 2. At term (≥ 37 weeks) 3. Able to fully understand Malay or English 4. Live fetus 5. Emergency/unplanned CS in labour (contractions ≥ 2 in 10 min, cervix ≥ 3 cm) |
| Key exclusion criteria | 1. Clinical indication for tranexamic acid 2. Contraindication to tranexamic acid 3. Known hypersensitivity to tranexamic acid 4. Known placenta previa/placenta accreta spectrum 5. Contraindications to tranexamic acid 6. Suspected current thromboembolic events 7. Known thrombophilia, coagulopathy or severe renal disease 8. History of venous thromboembolism |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 31/10/2024 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60379494422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | https://www.ummc.edu.my/# |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 30/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and /or analysed during the current study are/will be available upon request from Dr Shnkari Govindasamy, g.shnkari@ummc.edu.my |
Editorial Notes
25/07/2024: Study's existence confirmed by the Medical Research Ethics Committee, University of Malaya Medical Centre.
