Postpartum haemorrhage (PPH) Pregnancy and Childbirth
Conditions
Interventions
This is a phase III, randomised, double-blind, multicentre, international trial aiming to evaluate the efficacy and safety of heat-stable carbetocin (HSC) for treatment of postpartum haemorrhage (PPH)
Sponsors
World Health Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Had a singleton pregnancy 2. Had a vaginal birth 3. Receive HSC for PPH prophylaxis during the vaginal birth 4. Have an indication to receive uterotonics for the first response treatment of PPH presumably due to uterine atony (clinically diagnosed, or measured blood loss of 500 ml or more from the vagina, and where known coagulopathy and retained placenta has been excluded as the cause of bleeding) 5. Provided written informed consent before any trial-related procedures are carried out.
Exclusion criteria
Exclusion criteria: 1. Known history of allergy to HSC or oxytocin or excipients in the medicinal products used in the trial 2. Known serious coagulopathy, epilepsy, hepatic, renal, or cardiovascular disease 3. Known intrauterine foetal death 4. Birth that is considered an abortion according to local gestational age limit 5. Other clinically significant condition(s) that, in the opinion of the investigator could represent increased health risk for the participation of the woman or interfere with the objectives of the trial 6. A manual removal of placenta 7. A placenta in-situ that has not been expelled or removed 8. Known administration of any uterotonic for PPH treatment (e.g. prostaglandins, oxytocin, ergometrine) following PPH prophylaxis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women with additional vaginal blood loss of = 500 ml at 90 minutes following randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: 1. Additional blood loss of = 1000 ml at 90 minutes following randomisation 2. Use of additional uterotonic(s) at 90 minutes following randomisation 3. Additional blood loss of = 500 ml OR use of additional uterotonic(s) at 90 minutes following randomisation 4. Use of surgical procedure(s) related to PPH (uterine balloon tamponade, laparotomy for either compressive sutures, artery ligation or hysterectomy) as at 24 hours following randomisation 5. Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment up to 24 hours. Other secondary end-points: 6. Amount of blood loss at 90 minutes following randomisation 7. Use of additional uterotonics as at 24 hours following randomisation 8. Use of blood transfusion products as at 24 hours following randomisation 9. Admission to intensive care unit as at 24 hours following randomisation 10. Maternal death 11. Clinically defined coagulopathy as at 24 hours following randomisation 12. Breastfeeding as at 24 hours following randomisation 13. Occurrence of shock up to 24 hours following randomisation 14. Frequency and severity of adverse or serious adverse events as at 24 hours following randomisation 15. Composite outcome of maternal death or severe morbidity as at 24 hours following randomisation 16. Any haemodynamic change requiring therapeutic intervention during the 10 minutes of initiating treatment infusion 17. Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment in the first 10 minutes after initiating treatment infusion 18. Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which results in cardiac arrest during the first 24 hours following randomisation End-points specific to the safety substudy: 1. Reduction in mean arterial pressure (MAP) of > 20% from baseline in the first 5 minutes from the start of treatment infusion (main endpoint). 2. Persistent fal | — |
Countries
Argentina, India, Kenya, Nigeria, South Africa, Uganda, United Kingdom
Outcome results
None listed