I'M-WOMAN: Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05562609

Collaborator

UNITAID (Other)

30,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Tranexamic acid Other: Placebo	Phase 3

Detailed Description

Postpartum haemorrhage (PPH) causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The WOMAN trial recruited over 20,000 women with PPH and found that intravenous (IV) TXA given soon after PPH onset, reduces bleeding deaths by about a third. Early TXA also reduces blood loss in surgery and death due to bleeding after traumatic injury. The World Health Organization recommends that all women with PPH should receive TXA as a first line treatment.

TXA is more effective when given soon after the bleeding starts. Every fifteen minute delay reduces the survival benefit by about 10%. This suggests that giving TXA around the time of childbirth might prevent PPH. Although several clinical trials have examined the effectiveness of TXA for the prevention of PPH, the results are inconclusive. Trials of tranexamic acid for PPH prevention give the trial treatment after cord clamping, which may be too late to prevent bad bleeding in some women, as bleeding tends to happen soon after childbirth. Because PPH only affects a small proportion of births, the healthcare community need good evidence on the balance of benefits and harms in this population before using TXA to prevent PPH.

The I'M WOMAN trial will evaluate the effects of TXA for PPH prevention in women with one or more risk factors for PPH having a vaginal or caesarean birth. The trial will also evaluate the effect of the route of TXA administration. TXA is usually given by slow IV injection. However, recent research shows that TXA is well tolerated and rapidly absorbed after IM injection, achieving therapeutic blood levels within minutes of injection. There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route, as well as practical advantages.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

Tranexamic Acid by the Intramuscular or Intravenous Route for the Prevention of Postpartum Haemorrhage in Women at Increased Risk: a Randomised, Double-blind, Placebo-controlled Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intramuscular TXA 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 Ampoules and packaging for all arms will be identical in appearance. Other Names: Cyklokapron Other: Placebo Ampoules and packaging for all arms will be identical in appearance. Other Names: (Sodium Chloride 0.9%)
Active Comparator: Intravenous TXA 1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo	Drug: Tranexamic acid Ampoules and packaging for all arms will be identical in appearance. Other Names: Cyklokapron Other: Placebo Ampoules and packaging for all arms will be identical in appearance. Other Names: (Sodium Chloride 0.9%)
Placebo Comparator: Placebo Placebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections	Other: Placebo Ampoules and packaging for all arms will be identical in appearance. Other Names: (Sodium Chloride 0.9%)

Arm

Intervention/Treatment

Experimental: Intramuscular TXA

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