WORLD MATERNAL ANTIFIBRINOLYTIC TRIAL

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201007000192283
• Date of registration: 09/02/2010
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: WORLD MATERNAL ANTIFIBRINOLYTIC TRIAL
• Scientific title: Tranexamic acid for the treatment of postpartum haemorrhage: An international, randomised, double blind, placebo controlled trial
• Date of first enrolment: 2010-03-22
• Target sample size: 15000
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201007000192283
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order,; Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). ,

Countries of recruitment

South Africa

Contacts

• Name: Haleema Shakur
• Affiliation: Trial Manager

• Name: Haleema Shakur
• Affiliation: Trial Manager

Key inclusion & exclusion criteria

Inclusion criteria: Immediately after delivery, all usual care should be given for the prevention of PPH. If bleeding continues and a clinician diagnosis of PPH is made, all usual treatments should be given and at the same time assessment for inclusion in the WOMAN Trial should be done. As most women die within 2 - 4 hours of delivery, it is important to consider inclusion as early as possible. Clinician diagnosis of PPH may be based on any of the following:
1. Blood loss after vaginal delivery greater than 500 ml, or
2. Greater than 1000 ml after caesarian section, or
3. Blood loss enough to compromise the haemodynamic status of the woman

Other inclusion criteria:
4. All women who are clinician-diagnosed with postpartum haemorrhage following vaginal delivery or caesarean section
5. Consent has been obtained in line with local procedures
Exclusion criteria: 1. Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomised.
2. Women for whom the responsible clinician considers there is a clear contraindication for TXA should not be randomised.
There are no other pre-specified exclusion criteria. Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage, the woman should be randomised.


Age minimum: 16 Year
Age maximum: 150 Year
Gender: Female

Health Condition(s) or Problem(s) studied

Postpartum haemorrhage

Primary Outcome(s)

1. Composite of Death, and Peripartum hysterectomy

Secondary Outcome(s)

1. Surgical interventions used to treat obstetric haemorrhage: 1.1. Hysterectomy 1.2. Any brace suture 1.3. Arterial ligation 1.4. Artery selective embolisation

10. Status of baby/ies up to 6 weeks of delivery

11. Cost-effectiveness analysis

2. Transfusion requirements (blood/components)

3. Thromboembolic events: 3.1. Deep venous thrombosis 3.2. Pulmonary thromboembolism 3.3. Stroke 3.4. Myocardial infarction

4. Length of stay in hospital

5. If an Intensive Care Unit is available, time spent in the ICU

6. Suspected Unexpected Serious Adverse Reactions (SUSAR)

7. Death

8. Health Related Quality of life (HRQoL)

9. Receipt of mechanical ventilation

Secondary ID(s)

2008-008441-38

ISRCTN76912190

NCT00872469

Source(s) of Monetary Support

London School of Hygiene and Tropical Medicine