Condition category
Pregnancy and Childbirth
Date applied
23/11/2017
Date assigned
07/12/2017
Last edited
07/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims:
Postpartum haemorrhage (PPH) is characterised as a large amount of blood loss after giving birth. PPH is responsible for about 100,000 maternal deaths every year, almost all of which occur in low and middle income countries. When given within three hours of birth, tranexamic acid (a drug which helps in keeping blood clots firm) reduces deaths due to bleeding in women with PPH by almost one third. However, for many women, the use of tranexamic acid to treat PPH is too late to prevent death and severe health problems. Over one-third of pregnant women in the world are anaemic. The aim of this study is to progress the WOMAN-2 trial to see if giving tranexamic acid can prevent PPH and other severe outcomes in women with moderate and severe anaemia.

Who can participate?
Women with moderate or severe anaemia who are in the active stage of labour and plan to give birth vaginally are eligible (if their doctor believes there is no reason why the woman cannot receive the trial drug). Where a woman is less than 18 years old, unless she has an appropriate guardian available to witness the consent process, she cannot take part.

What does the study involve?
Women do not need to change their birth plans and they continue to receive all care and treatments which their doctor/midwife/nurse believe is required. Additionally, they are given a single injection of either tranexamic acid or a dummy drug (salty water) immediately the umbilical cord is cut or clamped and no later than 15 minutes after. Women are then be followed-up for a maximum 42 days. There is no special hospital visits required unless an adverse event occurs.

What are the possible benefits and risks of participating?
Women with anaemia have a higher risk of severe bleeding after childbirth and cannot afford to lose any blood. Tranexamic acid has been shown to reduce blood loss in surgery and can stop women dying from bleeding if they are treated as soon as possible. We do not know if giving tranexamic acid before bleeding develops will help reduce the risk of severe bleeding after childbirth and this trial will help us answer that question. Although there is a theoretical risk of forming clots where they are not wanted (e.g. deep vein thrombosis) with tranexamic acid, there is no evidence of this when available data is reviewed. Tranexamic acid can sometimes cause nausea, dizziness and diarrhoea.

Where is the study run from?
The trial will be coordinated by the Clinical Trials Unit at the London School of Hygiene and Tropical Medicine and supported by Regional Coordinating Centres in Pakistan (Rawalpindi Medical University) and Nigeria (University College Hospital, Ibadan).

When is the study starting and how long is it expected to run for?
January 2018 to January 2023

Who is the main contact?
Haleema Shakur-Still
woman2@lshtm.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Haleema Shakur-Still

ORCID ID

http://orcid.org/0000-0002-6511-109X

Contact details

Clinical Trials Unit
Keppel Street
London
WC1E 7HT
United Kingdom
+44(0)20 7299 4684
woman2@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WOMAN-2

Study information

Scientific title

Tranexamic acid for the prevention of postpartum bleeding in Women with anaemia: an international, randomised, double-blind, placebo controlled trial

Acronym

WOMAN-2

Study hypothesis

Can tranexamic acid by intravenous injection prevent PPH and other severe outcomes in women with moderate and severe anaemia?

Ethics approval

Not provided at time of registration.

Study design

A multi centre randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prevention of postpartum haemorrhage in women with moderate or severe anaemia having given birth vaginally

Intervention

Participants are randomly allocated to one of two groups. The randomisation list is generated by computer.

Active Comparator: Tranexamic acid, one intravenous injection of tranexamic acid. Total dose 1 gram (10mL).

Placebo Comparator: One Injection of 10 mL Sodium Chloride (0.9%).

Women receive clinically indicated care for the prevention of postpartum haemorrhage.

Intervention type

Drug

Phase

Phase III

Drug names

Tranexamic Acid

Primary outcome measures

Postpartum haemorrhage is measured using a clinical assessment (estimated blood loss of more than 500 mL or any blood loss sufficient to compromise haemodynamic stability) within 24 hours after administration of trial medication or discharge from discharge hospital whichever is earlier.

Secondary outcome measures

1. Postpartum blood loss is measured using a clinical assessment at 24 hours after administration of the trial medication or at discharge from hospital whichever is earlier
2. Haemaglobin is measured using Haemacue (Point of care test) at 24 hours after administration of the trial medication or at discharge from hospital whichever is earlier
3. Haemodynamic instability is measured based on clinical signs e.g. low blood pressure, tachycardia, reduced urine output requiring intervention e.g. intravenous fluid at 24 hours after administration of the trial medication or at discharge from hospital whichever is earlier
4. Shock index is measured using lowest recorded heart rate/systolic blood pressure at 24 hours after administration of the trial medication or at discharge from hospital whichever is earlier
5. Symptoms of anaemia is measured using a questionnaire developed specifically for this trial at 42 days or discharge from hospital whichever is earlier (please move this to number 5 if possible)
6. Quality of life, including overall wellbeing, ability to care for herself and her baby, breastfeeding (time to first feed, ability to sustain breastfeeding at discharge is measured using questionnaire at day 42 or discharge from hospital whichever is earlier (questionnaire specifically developed for this trial)
7. Expected side effects of trial medication is measured using patient self reports and medical records of nausea, vomiting, and diarrhoea at day 42 or discharge from hospital whichever is earlier
8. Exercise tolerance is measured using the 6 minute walk test at day 42 or discharge from hospital whichever is earlier (standardised test)
9. Interventions to control primary postpartum haemorrhage (including uterotonics, removal of placenta/placenta fragments, intrauterine balloon tamponade, bimanual uterine compression, external aortic compression, non-pneumatic anti-shock garments, uterine artery embolisation, uterine compression suture, hysterectomy and laparotomy to control bleeding) is measured using medical records at day 42 or discharge from hospital whichever is earlier
10. Vascular occlusive events including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI) are measured using from medical records at day 42 or discharge from hospital whichever is earlier
11. Organ dysfunction (cardiovascular, respiratory, renal, coagulation / haematological, hepatic, neurological) is measured using medical records at day 42 or discharge from hospital whichever is earlier
12. Sepsis is measured using medical records at day 42 or discharge from hospital whichever is earlier
13. In hospital death (with cause described) is measured using medical records at day 42 or discharge from hospital whichever is earlier
14. Length of hospital stay is measured using medical records at day 42 or discharge from hospital whichever is earlier
15. Admission to and time spent in higher level facility is measured using medical records at day 42 or discharge from hospital whichever is earlier
16. Status of baby/babies is measured using medical records definition at day 42 or discharge from hospital whichever is earlier
17. Thromboembolic events in breastfed babies are measured using medical records at 42 days or discharge from hospital whichever is earlier
18. Adverse events are measured as any untoward medical occurrences from medical records, patient self-report or report by any treating clinician up to day 42

Overall trial start date

01/11/2017

Overall trial end date

31/01/2023

Reason abandoned

Eligibility

Participant inclusion criteria

Women with moderate or severe anaemia (haemoglobin level <100 g/ L or packed cell volume <30%) after giving birth vaginally where the responsible clinician is substantially uncertain whether to use tranexamic acid.

Participant type

Patient

Age group

All

Gender

Female

Target number of participants

10000

Participant exclusion criteria

1. Women who are not legally adult (<18 years) and not accompanied by a guardian
2. Women with a known allergy to tranexamic acid or its excipients
3. Women who develop postpartum haemorrhage before randomisation

Recruitment start date

01/04/2018

Recruitment end date

31/01/2023

Locations

Countries of recruitment

Nigeria, Pakistan

Trial participating centre

Rizwana Chaudhri
National Coordinating Investigator (Pakistan) Rawalpindi Medical University
Rawalpindi
Punjab
Pakistan

Trial participating centre

Bukola Fawole
National Coordinating Investigator (Nigeria) University College Hospital, Ibadan
Ibadan
Oyo State
Nigeria

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Wellcome

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

Bill & Melinda Gates Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/01/2024

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes