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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
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 27, 2022
    Last Updated
    November 11, 2022
    Sponsor
    London School of Hygiene and Tropical Medicine
    Collaborators
    UNITAID
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    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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