Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]

• Sponsor: London School of Hygiene and Tropical Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04274335
• Collaborator: Rawalpindi Medical College (Other)
• Enrollment: 120
• Locations: 2
• Arms: 4
• Actual Duration (Months): 9.4
• Patients Per Site: 60
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief 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 undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)

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

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

• Study Type: Interventional
• Actual 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: Dec 18, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic [24 hours after randomisation]

   Concentration of TXA in Maternal blood over time

Secondary Outcome Measures

1. Placenta transfer of TXA [at birth of baby]

   Concentrations of TXA in placenta cord blood

2. Placenta transfer of TXA [within 24 hours of birth]

   Concentration of neonate TXA

3. Concentration of D-dimer [up to 24 hours after randomisation]

   Maternal blood concentration over time

4. Maternal blood volume lost [from incision to 2 hours from CS]

   total blood loss

5. frequency of Injection site reaction from IM administration [from randomisation up to 7 days after]

   Local reactions at injection site

6. Number of Adverse events (maternal and neonate) [from randomisation up to 7 days after]

   any untoward medical events

7. Number of women with a clinical diagnosis of PPH [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MCH PIMS	Islamabad		Pakistan
2	Women and Newborn Hospital	Lusaka		Zambia

Sponsors and Collaborators

• London School of Hygiene and Tropical Medicine
• Rawalpindi Medical College

Investigators

• Study Chair: Haleema Shakur-Still, London School of Hygiene and Tropical Medicine
• Study Chair: Ian Roberts, London School of Hygiene and Tropical Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT04274335
• Other Study ID Numbers: 2020-KEP-401
• First Posted: Feb 18, 2020
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tranexamic Acid

Study Results

No Results Posted as of Aug 19, 2022