One intravenous injection of tranexamic acid. Total dose 1 gram (10mL)

One Injection of the placebo which is 10 mL Sodium Chloride (0.9%)

Intrapartum - Moderate and Severe Anaemia

Ampoules and packaging for both arms will be identical in appearance.

Tranexamic Acid

Placebo

Ayub Teaching Hospital

Bahawalpur Victoria Hospital

Aziz Bhatti Teaching Hospital

MCH PIMS

Military Hospital

Civil Hospital

Jinnah Postgraduate Medical Centre

Jinnah Hospital

Services Hospital

Sir Ganga Ram Hospital

Chandka SMBBMU Sheikh Zaid Woman Hospital

Nishtar Hospital

Bolan Medical Centre

Benazir Bhutto Shaheed Hospital

Federal Government Polyclinic

Holy Family Hospital

Women and Newborn Hospital

World Maternal Antifibrinolytic Trial_2

Tranexamic Acid for the Prevention of Postpartum Bleeding in Women With Anaemia: an International, Randomised, Double-blind, Placebo Controlled Trial.

Clinical assessment: This may be an estimated blood loss of more than 500 mL or any blood loss sufficient to compromise haemodynamic stability within 24 hours of delivery. Haemodynamic instability is based on clinical judgement and assessed using clinical signs (low systolic blood pressure, tachycardia, reduced urine output).

Any of the following: 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

Any of the following:pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, myocardial infarction

measured using Quality of life Questionnaire and walk test

Any of the following: Cardiovascular, Respiratory, Renal, Hepatic, Neurological, Coagulation/ haematologic dysfunction

diagnosis is based on the presence of both infection and a systemic inflammatory response syndrome (SIRS). SIRS requires two or more of the following: a) temperature <36°C or >38°C (b) heart rate >90 beats/min (c) respiratory rate >20 breaths/min (d) white blood cell count <4x109/L (<4000/mm³) or >12x109/L (>12,000/mm³)

Cause and time of death will be described

High Dependency and/or Intensive Care Units

Any untoward medical occurance (other than expected complications)

Data will be shared publicly when all planned analyses are completed by the Woman-2 Trial Collaborators. This will be hosted on freebird.lshtm.ac.uk

London School of Hygiene and Tropical Medicine

Wellcome Trust

Bill and Melinda Gates Foundation

A randomised, double blind, placebo controlled trial among 10,000 women with moderate or severe anaemia having given birth vaginally.

Masking was 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 will be identical for tranexamic acid and placebo.

Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.

Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby

Post Partum Hemorrhage

TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.

5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.

Oxytocin

Harare Central Hospital

Parirenyatwa Group of Hospitals

Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

Blood loss equal to or exceeding 1000ml following elective caesarean section

Blood loss during caesarean section based on visual estimation and calculation.

Requirement by participant of blood transfusion

Use of additional uterotonics such as an oxytocin infusion or prostaglandin use

Any adverse effects related to tranexamic acid use

Incidence of emergency surgical procedures to manage any postpartum haemorrhage that occurs

Duration of participants' stay in hospital

Apgar scores out of 10 at 1 minute and 5 minute

Reason for and number of days from admission to and duration of stay in neonatal unit

It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors

Chipo Gwanzura, MD

Junior Registrar

University of Zimbabwe

Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.

uterine inertia/fatigue

World Maternal Antifibrinolytic Trial_2

Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

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