Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]
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ClinicalTrials.gov Identifier: NCT04274335 |
Recruitment Status :
Recruiting
First Posted : February 18, 2020
Last Update Posted : March 8, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy, High Risk | Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml Drug: Tranexamic Acid Oral Solution Drug: Tranexamic Acid Injectable Product | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | December 18, 2020 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Intravenous tranexamic acid |
Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
1 gram of tranexamic acid to be administered intravenously |
Experimental: Intramuscular tranexamic acid |
Drug: Tranexamic Acid Injectable Product
1 gram of tranexamic acid given as 2 separate intramuscular injection |
Experimental: Oral liquid tranexamic acid |
Drug: Tranexamic Acid Oral Solution
4 grams of tranexamic acid given as an oral solution |
No Intervention: No tranexamic acid |
- Pharmacokinetic [ Time Frame: 24 hours after randomisation ]Concentration of TXA in Maternal blood over time
- Placenta transfer of TXA [ Time Frame: at birth of baby ]Concentrations of TXA in placenta cord blood
- Placenta transfer of TXA [ Time Frame: within 24 hours of birth ]Concentration of neonate TXA
- Concentration of D-dimer [ Time Frame: up to 24 hours after randomisation ]Maternal blood concentration over time
- Maternal blood volume lost [ Time Frame: from incision to 2 hours from CS ]total blood loss
- frequency of Injection site reaction from IM administration [ Time Frame: from randomisation up to 7 days after ]Local reactions at injection site
- Number of Adverse events (maternal and neonate) [ Time Frame: from randomisation up to 7 days after ]any untoward medical events
- Number of women with a clinical diagnosis of PPH [ Time Frame: up to 24 hours after giving birth ]total blood loss of >1000 mL or any blood loss sufficient to cause haemodynamic instability or requires treatment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Women giving birth by caesarean section |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women admitted to hospital giving birth by CS
- History of at least one risk factor for PPH
- Adult (≥18 years old)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274335
Contact: Haleema Shakur-Still | +44 207 958 8113 | Haleema.Shakur@lshtm.ac.uk |
Pakistan | |
MCH PIMS | Recruiting |
Islamabad, Pakistan | |
Contact: S Batool | |
Zambia | |
Women and Newborn Hospital | Recruiting |
Lusaka, Zambia | |
Contact: K Lubeya |
Study Chair: | Haleema Shakur-Still | London School of Hygiene and Tropical Medicine | |
Study Chair: | Ian Roberts | London School of Hygiene and Tropical Medicine |
Responsible Party: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT04274335 |
Other Study ID Numbers: |
2020-KEP-401 |
First Posted: | February 18, 2020 Key Record Dates |
Last Update Posted: | March 8, 2022 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Totally anonymised dataset used for main analysis will be made freely available |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | freely available 1 year after main publication |
Access Criteria: | Free login to website required for monitoring usage of data |
URL: | https://freebird.lshtm.ac.uk |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |