Postpartum HemorrhagePhase 3I'M-WOMANNCT05562609
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
A Phase 3 study testing Tranexamic acid in people with Postpartum Hemorrhage, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40,000 participants
- Where
- 1 siteTanzania
- Study dates
- 22 Apr 2024to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who have a clear indication or contraindication for TXA
- Women with ongoing antepartum haemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ian Roberts contact
Tanzania1 site, 1 recruiting
- Recruiting
Mbeya Regional Referral Hospital
Mbeya
Soter Vitalis, MD
About this study
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
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.
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic acid, Placebo
- Keywords
- tranexamic acid, postpartum haemorrhage, bleeding, pregnancy, antifibrinolytic, intramuscular
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Cyklokapron
Ampoules and packaging for all arms will be identical in appearance.
PlaceboOther
Also called (Sodium Chloride 0.9%)
Ampoules and packaging for all arms will be identical in appearance.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Tranexamic acid; Other: Placebo |
| Intravenous TXA | Active comparator | 1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo Receives: Drug: Tranexamic acid; Other: Placebo |
| Placebo | Placebo comparator | Placebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 24 hours of childbirth
Secondary outcomes (19)
Intraoperative blood loss (caesarean births only)
Measured by quantifying the amount of blood in sponges and drapes used in surgery and blood loss from suctioning, excluding amniotic fluid
Measured: During surgery
Surgery duration (caesarean births only)
Measured using patient records
Measured: During surgery
Intraoperative whole blood/red cell transfusion (caesarean births only)
Measured using patient records
Measured: During surgery
Bleeding related death or near miss (key secondary outcome)
Any of the following:
- Death due to bleeding within 24 hours of birth
- Measured blood loss ≥1500ml, comprising intraoperative and drape-measured blood loss up to 2 hours after the end of CS surgery or vaginal birth
- Peripartum Hb drop ≥25g/L within 24 hours of birth
- Surgical intervention for bleeding (hysterectomy, laparotomy, embolization, uterine compression sutures, arterial ligation) within 24 hours of birth
- Blood transfusion of ≥5 units intraoperatively and up to 24 hours after birth
- Cardiovascular dysfunction (shock, cardiac arrest, continuous vasoactive drugs, severe hypoperfusion, severe acidosis, cardiopulmonary resuscitation)
- Renal dysfunction (oliguria non-responsive to fluids or diuretics, dialysis for acute renal failure, severe acute azotemia)
Measured: See description
Drape-measured postpartum blood loss
Measured using a calibrated obstetric drape starting immediately after vaginal birth or once the women are shifted to a bed in the observation area after CS surgery
Measured: 1 hour postpartum, or up to 2 hours if bleeding continues after 1 hour and the woman remains in bed
Blood pressure and heart rate
Lowest recorded blood pressure reading and associated heart rate measured using patient records
Measured: Up to 24 h after birth
Estimated postpartum blood loss
Measured: Up to 24 h after birth
Estimated postpartum blood loss (women with clinical diagnosis of PPH only)
Measured: At time of PPH diagnosis
Haemoglobin (Hb) or haematocrit (Hct)/packed cell volume (PCV), white cell count, platelet count
Measured: Up to 24 h after birth
Interventions for bleeding (uterotonics, non-trial TXA, blood transfusion, surgical and nonsurgical interventions)
Measured using patient records
Measured: Up to 24 h after birth
Nausea, vomiting, dizziness
Measured: At removal of calibrated drape
Pain or adverse skin reactions at injection sites
Measured: At removal of calibrated drape
Prespecified maternal adverse events (thromboembolic events, seizure, sepsis, organ dysfunction, coagulopathy)
Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Other maternal adverse events
Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Maternal mortality
All-cause, cause-specific, narrative; Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Length of hospital stay
Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Days in ICU/HDU
Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Transfer to another hospital
Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Prespecified neonatal outcomes (breastfeeding, intracranial haemorrhage, pulmonary haemorrhage, bruising, thromboembolic event, seizure, stillbirth/intrapartum death, neonatal death, cause of death, congenital and genetic abnormalities, adverse events)
Measured using patient records
Measured: Up to discharge, death or 42 days postpartum, whichever is first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start22 Apr 2024
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID
- Responsible party
- Sponsor
- Investigators
- Judith Lieber, Study director, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562609
- Sponsor's protocol ID
- IMWOMAN
- Acronym
- I'M-WOMAN
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39162220Brenner 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.
PubMed 38044460
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05562609
- Acronym / sponsor ID
- I'M-WOMAN / IMWOMAN
- Conditions
- Postpartum Hemorrhage
- Keywords
- tranexamic acid, postpartum haemorrhage, bleeding, pregnancy, antifibrinolytic, intramuscular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- UNITAID
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intramuscular TXA | Experimental | Drug: Tranexamic acid, Other: Placebo1g 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) |
| Intravenous TXA | Active comparator | Drug: Tranexamic acid, Other: Placebo1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo |
| Placebo | Placebo comparator | Other: PlaceboPlacebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Women who have a clear indication or contraindication for TXA
- Women with ongoing antepartum haemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: CyklokapronAmpoules and packaging for all arms will be identical in appearance. | Drug | Intramuscular TXA, Intravenous TXA |
| PlaceboAlso: (Sodium Chloride 0.9%)Ampoules and packaging for all arms will be identical in appearance. | Other | Intramuscular TXA, Intravenous TXA, Placebo |
Primary outcome
Risk of Postpartum haemorrhage
Time frame: within 24 hours of childbirth
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)
19 secondary outcomes
Intraoperative blood loss (caesarean births only)
Time frame: During surgery
Surgery duration (caesarean births only)
Time frame: During surgery
Intraoperative whole blood/red cell transfusion (caesarean births only)
Time frame: During surgery
Bleeding related death or near miss (key secondary outcome)
Time frame: See description
Drape-measured postpartum blood loss
Time frame: 1 hour postpartum, or up to 2 hours if bleeding continues after 1 hour and the woman remains in bed
Blood pressure and heart rate
Time frame: Up to 24 h after birth
Estimated postpartum blood loss
Time frame: Up to 24 h after birth
Estimated postpartum blood loss (women with clinical diagnosis of PPH only)
Time frame: At time of PPH diagnosis
Haemoglobin (Hb) or haematocrit (Hct)/packed cell volume (PCV), white cell count, platelet count
Time frame: Up to 24 h after birth
Interventions for bleeding (uterotonics, non-trial TXA, blood transfusion, surgical and nonsurgical interventions)
Time frame: Up to 24 h after birth
Nausea, vomiting, dizziness
Time frame: At removal of calibrated drape
Pain or adverse skin reactions at injection sites
Time frame: At removal of calibrated drape
Prespecified maternal adverse events (thromboembolic events, seizure, sepsis, organ dysfunction, coagulopathy)
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Other maternal adverse events
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Maternal mortality
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Length of hospital stay
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Days in ICU/HDU
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Transfer to another hospital
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Prespecified neonatal outcomes (breastfeeding, intracranial haemorrhage, pulmonary haemorrhage, bruising, thromboembolic event, seizure, stillbirth/intrapartum death, neonatal death, cause of death, congenital and genetic abnormalities, adverse events)
Time frame: Up to discharge, death or 42 days postpartum, whichever is first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 39162220Larson 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.
- Derived from this study: PubMed 38044460Brenner 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Roberts contact
Judith Lieber study director
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid in people with Postpartum Hemorrhage, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Lieber (+44 (0)20 7958 8283, imwoman@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Postpartum haemorrhage (time frame: within 24 hours of childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.