Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk (I'M-WOMAN)
Primary Purpose
Postpartum Hemorrhage
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring tranexamic acid, postpartum haemorrhage, bleeding, pregnancy, antifibrinolytic, intramuscular
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Intramuscular TXA
Intravenous TXA
Placebo
Arm Description
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)
1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo
Placebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05562609
First Posted
September 27, 2022
Last Updated
November 11, 2022
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
UNITAID
1. Study Identification
Unique Protocol Identification Number
NCT05562609
Brief Title
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Acronym
I'M-WOMAN
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
UNITAID
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
tranexamic acid, postpartum haemorrhage, bleeding, pregnancy, antifibrinolytic, intramuscular
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
30000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intramuscular TXA
Arm Type
Experimental
Arm Description
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)
Arm Title
Intravenous TXA
Arm Type
Active Comparator
Arm Description
1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Cyklokapron
Intervention Description
Ampoules and packaging for all arms will be identical in appearance.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
(Sodium Chloride 0.9%)
Intervention Description
Ampoules and packaging for all arms will be identical in appearance.
Primary Outcome Measure Information:
Title
Risk of Postpartum haemorrhage
Description
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)
Time Frame
within 24 hours of childbirth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Brenner
Phone
+44 (0)20 7958 8283
Email
imwoman@lshtm.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Roberts
Phone
+44 (0)20 7958 8128
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Brenner
Organizational Affiliation
London School oh Hygiene and Tropical Medicine
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators are committed to sharing data for ethical research with justified scientific objectives. Until all planned analyses are completed by the LSHTM CTU Global Health Trials Group, data will be shared through a controlled access approach whereby researchers can make formal applications for data sharing. Afterwards, the anonymised dataset will be shared via the LSHTM CTU Global Health Trials Group data sharing platform at freebird.lshtm.ac.uk. All trial materials including training materials, CRFs and Protocol will be made available on the trial website and team YouTube channel.
IPD Sharing Time Frame
Once all planned analyses are completed by the LSHTM CTU Global Health Trials Group following trial completion. Data will be shared indefinitely.
IPD Sharing Access Criteria
As above
IPD Sharing URL
http://freebird.lshtm.ac.uk
Learn more about this trial
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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