Prevention of postpartum haemorrhage in women with moderate or severe anaemia having given birth vaginally Pregnancy and Childbirth Women with moderate or severe anaemia having given birth vaginally
Conditions
Interventions
Current intervention as of 21/12/2023
Participants are randomly allocated to one of two groups. The randomisation list is generated by computer.
Active Comparator: Tranexamic acid, one intravenous in
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%) after giving birth vaginally where the responsible clinician is substantially uncertain whether to use tranexamic acid.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 08/08/2018: 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 hospital (whichever is earlier). The cause of postpartum haemorrhage will be described. Previous primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/08/2018: 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. Haemoglobin 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, uter | — |
Countries
Nigeria, Pakistan, Tanzania, Zambia
Contacts
Public ContactEni Balogun
Outcome results
None listed