Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305473136570 Date of Approval: 18/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tranexamic acid to prevent heavy bleeding after childbirth in women at higher risk
Official scientific 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
Brief summary describing the background and objectives of the trial Heavy bleeding after childbirth, known as 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 from 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IM WOMAN
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2023
Actual trial start date 22/04/2024
Anticipated date of last follow up 14/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 30000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT05562609 Clinicaltrials.gov
ISRCTN12590098 ISRCTN
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intramuscular TXA 1g TXA IV - slow IV injection over 10 minutes (1mL/minute) IM - two injections into the muscle 1g TXA as 2 x 5mL IM injections (100 mg/mL) and slow IV injection of placebo (1 x 10mL of 0.9% Sodium chloride) 1
Control Group Intravenous TXA 1g TXA IV - slow IV injection over 10 minutes (1mL/min) IM - two injections into the muscle 1g TXA by slow IV injection and 2 x 5mL IM injections of placebo (0.9% Sodium chloride) 0 Active-Treatment of Control Group
Control Group Placebo matching placebo (0.9% Sodium chloride) IV - slow IV injection over 10 minutes (1mL/minute) IM - two injections into the muscle Placebo (0.9% Sodium chloride) by 1 x 10mL slow IV injection and 2 x 5mL IM injections 0 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women thought to be aged 18 years or over admitted to hospital for a vaginal or caesarean birth 2. One or more risk factors for PPH including but not limited to: a) Maternal age ≥ 35 years b) Grand multiparity (at least 5 previous births) c) Multiple pregnancies d) Planned caesarean section e) Preterm birth f) Previous PPH g) Hypertensive disease h) Abnormal placental implantation i) Antepartum haemorrhage or placental abruption present j) Moderate or severe anaemia k) Other risk factors 1. Tranexamic acid is clearly indicated (e.g. tranexamic acid has been given within 12 hours or planned to be given) 2. Tranexamic acid is clearly contraindicated (e.g. known allergy to tranexamic acid) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/01/2023 London School of Hygiene and Tropical Medicine LSHTM
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/03/2023 London School of Hygiene and Tropical Medicine LSHTM
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/05/2023 National Health Research Ethics Committee of Nigeria NHREC
Ethics Committee Address
Street address City Postal code Country
Department of Health Planning, Research and Statistics, Federal Ministry of Health, 11th Floor, Federal Secretariat Complex Phase III, Ahmadu Bello Way, Abuja Abuja 900242 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/04/2023 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical diagnosis of postpartum haemorrhage - May be based on estimated blood loss >500 mL in vaginal birth, or >1000 mL in caesarean birth, or any blood loss sufficient to compromise haemodynamic stability, within 24 hours of birth. Haemodynamic instability is based on clinical judgement and assessed using clinical signs (low blood pressure, tachycardia, falling urine output). Within 24 hours of birth
Secondary Outcome Intraoperative blood loss - caesarean births only During caesarean section
Secondary Outcome Surgery duration - caesarean births only During caesarean section
Secondary Outcome Intraoperative whole blood/red cell transfusion - caesarean births only During caesarean section
Secondary Outcome Postoperative haemoglobin (Hb) or packed cell volume (PCV) - caesarean births only Up to the end of the second postoperative day
Secondary Outcome Drape measured postpartum blood loss For 1 hour after birth, or up to 2 hours if bleeding continues after 1 hour and woman remains lying down
Secondary Outcome Blood pressure and heart rate up to 24 hours after birth
Secondary Outcome Total estimated blood loss at time of PPH diagnosis up to 24 hours after birth
Secondary Outcome Interventions for bleeding (non-trial TXA, additional uterotonics for PPH, bimanual compression, cervical/vaginal sutures, brace sutures, hysterectomy for bleeding, external aortic compression, perineal sutures, other laparotomy for bleeding, arterial ligation or embolisation, intrauterine tamponade, vaginal/perineal packing, units of whole blood/red cells transfused) up to 24 hours after birth
Secondary Outcome Nausea score, number of episodes of retching and vomiting, dizziness score when the calibrated obstetric drape is removed, up to 2 hours after birth
Secondary Outcome Pain or significant skin reactions at intramuscular or intravenous injection sites when the calibrated obstetric drape is removed, up to 2 hours after birth
Secondary Outcome Prespecified maternal adverse events (myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism, seizure, sepsis, cardiovascular dysfunction, renal dysfunction, respiratory dysfunction, coagulopathy, other organ dysfunction) up to discharge, death or 42 days postpartum, whichever is first
Secondary Outcome Maternal mortality up to discharge, death or 42 days postpartum, whichever is first
Secondary Outcome Length of hospital stay up to discharge, death or 42 days postpartum, whichever is first
Secondary Outcome Days in ICU/HDU up to discharge, death or 42 days postpartum, whichever is first
Secondary Outcome Transfer to another hospital up to discharge, death or 42 days postpartum, whichever is first
Secondary Outcome Prespecified neonatal outcomes (stillbirth or intrapartum death, neonatal death, breastfeeding, congenital/genetic abnormality, intracranial haemorrhage, pulmonary haemorrhage, bruising, thromboembolic event, seizure) up to discharge, death or 42 days postpartum, whichever is first
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Ibadan Queen Elizabeth Road, PMB 5116 Ibadan 200285 Nigeria
University of Ilorin Teaching Hospital Along Old Jebba Road, PMB 1459 Ilorin 241102 Nigeria
Adeoyo Maternity Teaching Hospital Yemetu Street, PMB 5115 Ibadan 200285 Nigeria
University of Medical Sciences Teaching Hospital UNIMEDTH Laje Road, PMB 536 Ondo Nigeria
Ilorin General Hospital 5 Unity Road Ilorin 240101 Nigeria
Rivers State University Teaching Hospital 6-8 Harley Street Port Harcourt 500241 Nigeria
Jos University Teaching Hospital Off Lamingo Road, Katon Rikkos Jos 930105 Nigeria
University of Benin Teaching Hospital Benin-Lagos Express Way Benin 300001 Nigeria
Abubakar Tafawa Balewa University Teaching Hospital No 1 Hospital Road off Yandoka Road, PMB 0117 Bauchi 740102 Nigeria
Ladoke Akintola University of Technology Teaching Hospital LAUTECH Ilorin-Ibadan Road, PMB 4000 Ogbomoso 212102 Nigeria
Amana Regional Referral Hospital PO Box 25411, Ilala Dar es Salaam Tanzania
Dodoma Regional Referral Hospital Madukani Street, PO Box 904 Dodoma Tanzania
Mbeya Regional Referral Hospital New Forest Street, PO Box 259 Mbeya Tanzania
Mbeya Zonal Referral Hospital Hospital Hill Road, PO Box 419 Mbeya Tanzania
Morogoro Regional Referral Hospital Rwegasore Street, PO Box 110 Morogoro Tanzania
Mount Meru Regional Referral Hospital East Africa Road, PO Box 3092 Arusha Tanzania
Muhimbili National Hospital Mindu Street, PO Box 65000, Ilala Dar es Salaam Tanzania
Mwananyamala Regional Referral Hospital Mwananyamala Street, PO Box 61665, Kinondoni District Dar es Salaam Tanzania
Temeke Regional Referral Hospital 12 Sungwi Street, PO Box 45232 Dar es Salaam Tanzania
Tumbi Regional Referral Hospital PO Box 30041 Kibaha Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Unitaid Unitaid - Global Health Campus, Chemin du Pommier 40, 5th Floor Geneva 1218 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
STMU LSHTM Research Collaboration Centre Shifa Tameer-e-Millat University, STMU Campus, Shifa International Hospital, Pitras Bukhari Road Islamabad Pakistan
COMUI LSHTM Research Collaboration Centre College of Medicine, University of Ibadan, Queen Elizabeth Road Ibadan Nigeria
UDSM LSHTM Research Collaboration Centre University of Dar es Salaam, Mbeya College of Health and Allied Sciences Dar es Salaam Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ian Roberts imwoman@lshtm.ac.uk +442079588283 London School of Hygiene and Tropical Medicine LSHTM, Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor Clinical Trials Unit Global Health Trials Group
Role Name Email Phone Street address
Public Enquiries Amy Brenner imwoman@lshtm.ac.uk +442079588283 London School of Hygiene and Tropical Medicine LSHTM, Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Research Fellow Clinical Trials Unit Global Health Trials Group
Role Name Email Phone Street address
Scientific Enquiries Ian Roberts imwoman@lshtm.ac.uk +442079588283 London School of Hygiene and Tropical Medicine, Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor Clinical Trial Unit Global Health Trials Group
Role Name Email Phone Street address
Public Enquiries Projestine Muganyizi tanzania.imwoman@lshtm-ctu.org +25525200082 PO Box 35091
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania UDSM LSHTM Research Collaboration Centre University of Dar es Salaam Mbeya College of Health and Allied Sciences
Role Name Email Phone Street address
Public Enquiries Oladapo Olayemi nigeria.imwoman@lshtm-ctu.org +442079588517 Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan Nigeria COMUI LSHTM Research Collaboration Centre College of Medicine University of Ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The main publication of the trial results will be in the name of the Trial Collaborative Group (I'M WOMAN Trial Collaborators). We 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 https://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. Informed Consent Form,Study Protocol 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, totally anonymised data will be shared via the LSHTM CTU Global Health Trials Group data sharing platform at https://freebird.lshtm.ac.uk/. There is no end date for sharing. 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, totally anonymised data will be shared via the LSHTM CTU Global Health Trials Group data sharing platform at https://freebird.lshtm.ac.uk/.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
freebird.lshtm.ac.uk No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information