Pregnancy, High RiskPhase 2NCT04274335
Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]
A Phase 2 study testing Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, Tranexamic Acid Oral Solution and Tranexamic Acid Injectable Product in people with Pregnancy, High Risk, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, High Risk
- What is being tested?
- Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, Tranexamic Acid Oral Solution and Tranexamic Acid Injectable Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Dec 2020to 30 Sep 2021
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women admitted to hospital giving birth by CS
- History of at least one risk factor for PPH
- Adult (≥18 years old)
Who cannot join
- Women giving birth vaginally
- Women with a known allergy to TXA or its excipients
- Women with current antepartum haemorrhage
- Women known to have received TXA within 48 hours prior to randomisation
- Women with known renal impairment
- Women with any known blood clotting disorder
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of Intramuscular, Intravenous and Oral Administration of Tranexamic Acid in Women Giving Birth by Caesarean Section
Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)
Read the detailed description
An open label, randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral solution administration of tranexamic acid in women giving birth by caesarean section. 120 women (30 receiving oral liquid, 30 receiving intramuscular, 30 receiving intravenous and 30 receiving no TXA who have at least 6 evaluable PK samples will be randomised.
- Conditions
- Pregnancy, High Risk
- Being tested
- Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, Tranexamic Acid Oral Solution, Tranexamic Acid Injectable Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 100Mg/Ml Inj Vil 10MlDrug
1 gram of tranexamic acid to be administered intravenously
Tranexamic Acid Oral SolutionDrug
4 grams of tranexamic acid given as an oral solution
Tranexamic Acid Injectable ProductDrug
1 gram of tranexamic acid given as 2 separate intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Intravenous tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml |
| Intramuscular tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic Acid Injectable Product |
| Oral liquid tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic Acid Oral Solution |
| No tranexamic acid | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic
Concentration of TXA in Maternal blood over time
Measured: 24 hours after randomisation
Secondary outcomes (7)
Placenta transfer of TXA
Concentrations of TXA in placenta cord blood
Measured: at birth of baby
Placenta transfer of TXA
Concentration of neonate TXA
Measured: within 24 hours of birth
Concentration of D-dimer
Maternal blood concentration over time
Measured: up to 24 hours after randomisation
Maternal blood volume lost
total blood loss
Measured: from incision to 2 hours from CS
frequency of Injection site reaction from IM administration
Local reactions at injection site
Measured: from randomisation up to 7 days after
Number of Adverse events (maternal and neonate)
any untoward medical events
Measured: from randomisation up to 7 days after
Number of women with a clinical diagnosis of PPH
total blood loss of >1000 mL or any blood loss sufficient to cause haemodynamic instability or requires treatment
Measured: up to 24 hours after giving birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start18 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Rawalpindi Medical College
- Responsible party
- Sponsor
- Investigators
- Haleema Shakur-Still, Study chair, London School of Hygiene and Tropical MedicineIan Roberts, Study chair, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274335
- Sponsor's protocol ID
- 2020-KEP-401
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Totally anonymised dataset used for main analysis will be made freely available
Publications
Shakur-Still H, Roberts I, Grassin-Delyle S, Chaudhri R, Geer A, Arribas M, Lamy E, Mansukhani R, Lubeya MK, Javaid K, Kayani A, Israr N, Mazhar SB, Urien S, Bouazza N, Foissac F, Prowse D, Carrington L, Barrow C, Onandia JG, Balogun E. Alternative routes for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological study in caesarean section births. BJOG. 2023 Sep;130(10):1177-1186. doi: 10.1111/1471-0528.17455. Epub 2023 Apr 5.
PubMed 37019443Arribas M, Roberts I, Chaudhri R, Geer A, Prowse D, Lubeya MK, Kayani A, Javaid K, Grassin-Delyle S, Shakur-Still H. WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section. Wellcome Open Res. 2021 Jun 16;6:157. doi: 10.12688/wellcomeopenres.16884.1. eCollection 2021.
PubMed 34250266
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of Intramuscular, Intravenous and Oral Administration of Tranexamic Acid in Women Giving Birth by Caesarean Section
- ClinicalTrials.gov ID
- NCT04274335
- Acronym / sponsor ID
- 2020-KEP-401
- Conditions
- Pregnancy, High Risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Rawalpindi Medical College
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 18 Feb 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.
Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)
Detailed description
An open label, randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral solution administration of tranexamic acid in women giving birth by caesarean section. 120 women (30 receiving oral liquid, 30 receiving intramuscular, 30 receiving intravenous and 30 receiving no TXA who have at least 6 evaluable PK samples will be randomised.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous tranexamic acid | Experimental | Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml |
| Intramuscular tranexamic acid | Experimental | Drug: Tranexamic Acid Injectable Product |
| Oral liquid tranexamic acid | Experimental | Drug: Tranexamic Acid Oral Solution |
| No tranexamic acid | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women admitted to hospital giving birth by CS
- History of at least one risk factor for PPH
- Adult (≥18 years old)
Key exclusion criteria (6 listed)
- Women giving birth vaginally
- Women with a known allergy to TXA or its excipients
- Women with current antepartum haemorrhage
- Women known to have received TXA within 48 hours prior to randomisation
- Women with known renal impairment
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 100Mg/Ml Inj Vil 10Ml1 gram of tranexamic acid to be administered intravenously | Drug | Intravenous tranexamic acid |
| Tranexamic Acid Oral Solution4 grams of tranexamic acid given as an oral solution | Drug | Oral liquid tranexamic acid |
| Tranexamic Acid Injectable Product1 gram of tranexamic acid given as 2 separate intramuscular injection | Drug | Intramuscular tranexamic acid |
Primary outcome
Pharmacokinetic
Time frame: 24 hours after randomisation
Concentration of TXA in Maternal blood over time
7 secondary outcomes
Placenta transfer of TXA
Time frame: at birth of baby
Placenta transfer of TXA
Time frame: within 24 hours of birth
Concentration of D-dimer
Time frame: up to 24 hours after randomisation
Maternal blood volume lost
Time frame: from incision to 2 hours from CS
frequency of Injection site reaction from IM administration
Time frame: from randomisation up to 7 days after
Number of Adverse events (maternal and neonate)
Time frame: from randomisation up to 7 days after
Number of women with a clinical diagnosis of PPH
Time frame: up to 24 hours after giving birth
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 23 May 2023.
- Derived from this study: PubMed 37019443Shakur-Still H, Roberts I, Grassin-Delyle S, Chaudhri R, Geer A, Arribas M, Lamy E, Mansukhani R, Lubeya MK, Javaid K, Kayani A, Israr N, Mazhar SB, Urien S, Bouazza N, Foissac F, Prowse D, Carrington L, Barrow C, Onandia JG, Balogun E. Alternative routes for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological study in caesarean section births. BJOG. 2023 Sep;130(10):1177-1186. doi: 10.1111/1471-0528.17455. Epub 2023 Apr 5.
- Derived from this study: PubMed 34250266Arribas M, Roberts I, Chaudhri R, Geer A, Prowse D, Lubeya MK, Kayani A, Javaid K, Grassin-Delyle S, Shakur-Still H. WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section. Wellcome Open Res. 2021 Jun 16;6:157. doi: 10.12688/wellcomeopenres.16884.1. eCollection 2021.
- Individual participant dataSharing planned: Yes. Totally anonymised dataset used for main analysis will be made freely available
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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.
Haleema Shakur-Still study chair
London School of Hygiene and Tropical Medicine
Ian Roberts study chair
London School of Hygiene and Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, Tranexamic Acid Oral Solution and Tranexamic Acid Injectable Product in people with Pregnancy, High Risk, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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 23 May 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 Pakistan, Zambia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetic (time frame: 24 hours after randomisation). 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 NCT04274335, which also lists 2 linked publications.
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 23 May 2023.