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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05562609
Other study ID # IMWOMAN
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 22, 2024
Est. completion date September 2025

Study information

Verified date December 2023
Source London School of Hygiene and Tropical Medicine
Contact Amy Brenner
Phone +44 (0)20 7958 8283
Email imwoman@lshtm.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date September 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Women who have a clear indication or contraindication for TXA

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic acid
Ampoules and packaging for all arms will be identical in appearance.
Other:
Placebo
Ampoules and packaging for all arms will be identical in appearance.

Locations

Country Name City State
Tanzania Mbeya Regional Referral Hospital Mbeya

Sponsors (2)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine UNITAID

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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