Pregnancy and Childbirth
Conditions
Interventions
Tranexamic Acid
Sodium Chloride 0.9 percent
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with moderate or severe anaemia (haemoglobin level <100 g/L or packed cell volume <30%), and who have given birth vaginally and for who the responsible clinician is substantially uncertain whether to use TXA.
Exclusion criteria
Exclusion criteria: Women who are not legally adult (<18 years) and permission not provided by a guardian. Women with a known allergy to TXA or its excipients. Women who develop PPH before umbilical cord is clamped/cut.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Vascular occlusive events - Any of the following:pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, myocardial infarction;Postpartum blood loss - Clinical assessment;Haemaglobin - Haemacue (Point of care test);Haemodynamic instability - Defined as per protocol ;Shock index - Heart rate/systolic blood pressure;Quality of Life (maternal) - Defined as per protocol;Expected side effects of trial medication - nausea, vomiting, diarrhoea;Exercise tolerance - 6 minute walk test;Receipt of blood product transfusion - units and type;Symptoms of anaemia - measured using Quality of life Questionnaire and walk test;Organ disfunction - Any of the following: Cardiovascular, Respiratory, Renal, Hepatic, Neurological, Coagulation/ haematologic dysfunction ;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 38°C (b) heart rate >90 beats/min (c) respiratory rate >20 breaths/min (d) white blood cell count 12x109/L (>12,000/mm³);In hospital death - cause of death will be described;Length of hospital stay - days;Admission to and time spent in higher level facility - High Dependency and/or Intensive Care Units;Status of baby/ies - alive or dead;Thromboembolic events in breastfed babies - as defined in protocol;Adverse events - Any untoward medical occurance (other than expected complications) | — |
Countries
Nigeria, Pakistan, United Republic of Tanzania, Zambia
Contacts
Public ContactHaleema Shakur Still
Chief Investigator and Co Director of the Clinical Trials Unit in the London School of Hygiene and Tropical Medicine
Outcome results
None listed