| OUTCOMES |
|
Type of outcome
|
Outcome
|
Timepoint(s) at which outcome measured
|
| Primary Outcome |
Postpartum Haemorrhage (cause will be described) - 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). |
24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Postpartum blood loss - Clinical assessment |
24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Haemaglobin - Haemacue (Point of care test) |
24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Haemodynamic instability - Defined as per protocol
|
24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Shock index - Heart rate/systolic blood pressure |
24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Quality of Life (maternal) - Defined as per protocol |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Expected side effects of trial medication - nausea, vomiting, diarrhoea |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Exercise tolerance - 6 minute walk test |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Interventions to control primary postpartum haemorrhage (medical and surgical) - 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 |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Receipt of blood product transfusion - units and type |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Vascular occlusive events - Any of the following:pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, myocardial infarction |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Symptoms of anaemia - measured using Quality of life Questionnaire and walk test |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Organ disfunction - Any of the following: Cardiovascular, Respiratory, Renal, Hepatic, Neurological, Coagulation/ haematologic dysfunction
|
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Sepsis - 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) |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
In hospital death - cause of death will be described |
Day 42 |
| Secondary Outcome |
Length of hospital stay - days |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Admission to and time spent in higher level facility - High Dependency and/or Intensive Care Units |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Status of baby/ies - alive or dead |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Thromboembolic events in breastfed babies - as defined in protocol |
Day 42 after administration of the trial medication or at discharge from hospital, whichever is earlier |
| Secondary Outcome |
Adverse events - Any untoward medical occurance (other than expected complications) |
Day 42 |