Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk

NCT05562609 | Recruiting Phase 3 DMC

• 1 other identifier: IMWOMAN
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.

Conditions

Postpartum Hemorrhage

Keywords

tranexamic acid; postpartum haemorrhage; bleeding; pregnancy; antifibrinolytic; intramuscular

Outcome Measures

Primary Outcomes (1)

• Risk of Postpartum haemorrhage

  Clinical assessment: This may be an estimated blood loss of more than 500 mL in vaginal births or more than 1000 ml in caesarean births, or any blood loss sufficient to compromise haemodynamic stability. Haemodynamic instability is based on clinical judgement and assessed using clinical signs (low systolic blood pressure, tachycardia, reduced urine output)

  within 24 hours of childbirth

Study Arms (3)

Intramuscular TXA

EXPERIMENTAL

1g TXA as 2 x 5 ml IM injections (100mg/ml) and slow IV injection of placebo (1 x 10 ml of 0.9% sodium chloride)

Drug: Tranexamic acid; Other: Placebo

Intravenous TXA

ACTIVE COMPARATOR

1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo

Drug: Tranexamic acid; Other: Placebo

Placebo

PLACEBO COMPARATOR

Placebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections

Other: Placebo

Interventions

Tranexamic acid DRUG

Ampoules and packaging for all arms will be identical in appearance.

Also known as: Cyklokapron

Intramuscular TXA; Intravenous TXA

Placebo OTHER

Ampoules and packaging for all arms will be identical in appearance.

Also known as: (Sodium Chloride 0.9%)

Intramuscular TXA; Intravenous TXA; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for PPH

You may not qualify if:

• Women who have a clear indication or contraindication for TXA

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• UNITAID: collaborator

Study Sites (1)

Mbeya Regional Referral Hospital

Mbeya, Tanzania

RECRUITING

Related Publications (2)

• Larson NJ, Mergoum AM, Dries DJ, Cook A, Blondeau B, Rogers FB. THE ROLE OF TRANEXAMIC ACID IN POSTPARTUM HEMORRHAGE: A NARRATIVE REVIEW. Shock. 2024 Nov 1;62(5):620-627. doi: 10.1097/SHK.0000000000002455. Epub 2024 Aug 20.

  PMID: 39162220 DERIVED

• Brenner A, Shakur-Still H, Chaudhri R, Muganyizi P, Olayemi O, Arribas M, Kayani A, Javid K, Bello A, Roberts I; I'M WOMAN Trial Collaborative Group. Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial (I'M WOMAN). Trials. 2023 Dec 3;24(1):782. doi: 10.1186/s13063-023-07687-1.

  PMID: 38044460 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Amy Brenner

  London School oh Hygiene and Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Amy Brenner

CONTACT

+44 (0)20 7958 8283; imwoman@lshtm.ac.uk

Ian Roberts

CONTACT

+44 (0)20 7958 8128

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking done by an independent clinical trials supply company. It will involve the removal of the original manufacturer's label and replacement with the clinical trial label bearing the randomisation number, which will be used as the pack identification. Apart from the randomisation number, all pack label texts and ampoules will be identical for each arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 3, 2022
• Study Start: April 22, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once all planned analyses are completed by the LSHTM CTU Global Health Trials Group following trial completion. Data will be shared indefinitely.
• Access Criteria: As above

Locations

TA (1)