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

NCT04274335 | Completed Phase 2 DMC

• 1 other identifier: 2020-KEP-401
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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)

Conditions

Pregnancy, High Risk

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic

  Concentration of TXA in Maternal blood over time

  24 hours after randomisation

Secondary Outcomes (7)

• Placenta transfer of TXA

  at birth of baby

• Placenta transfer of TXA

  within 24 hours of birth

• Concentration of D-dimer

  up to 24 hours after randomisation

• Maternal blood volume lost

  from incision to 2 hours from CS

• frequency of Injection site reaction from IM administration

  from randomisation up to 7 days after

Study Arms (4)

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

Interventions

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml DRUG

1 gram of tranexamic acid to be administered intravenously

Intravenous tranexamic acid

Tranexamic Acid Oral Solution DRUG

4 grams of tranexamic acid given as an oral solution

Oral liquid tranexamic acid

Tranexamic Acid Injectable Product DRUG

1 gram of tranexamic acid given as 2 separate intramuscular injection

Intramuscular tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women giving birth by caesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women admitted to hospital giving birth by CS
• History of at least one risk factor for PPH
• Adult (≥18 years old)

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Rawalpindi Medical College: collaborator

Study Sites (2)

MCH PIMS

Islamabad, Pakistan

Location

Women and Newborn Hospital

Lusaka, Zambia

Location

Related Publications (2)

• 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.

  PMID: 37019443 DERIVED

• Arribas 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.

  PMID: 34250266 DERIVED

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Haleema Shakur-Still

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

• Ian Roberts

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: December 18, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 23, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: freely available 1 year after main publication
• Access Criteria: Free login to website required for monitoring usage of data

Locations

ZA (1); PA (1)