postpartum haemorrhage
Conditions
Interventions
Heat stable carbetocin HSC
oxytocin
Sponsors
WHO
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participants will be eligible for randomization if they fulfil all the following criteria: • had a singleton pregnancy • had a vaginal birth • receive HSC for PPH prophylaxis during the vaginal birth • 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) • provided written informed consent before any trial-related procedures are carried out.
Exclusion criteria
Exclusion criteria: Participants will be excluded from participating in the trial if they have any of the following criteria: • known history of allergy to HSC or oxytocin or excipients in the medicinal products used in the trial • known serious coagulopathy, epilepsy, hepatic, renal, or cardiovascular disease • known intrauterine fetal death • birth that is considered an abortion according to local gestational age limit • 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 • a manual removal of placenta • a placenta in-situ that has not been expelled or removed • known administration of any uterotonic for PPH treatment (e.g. prostaglandins, oxytocin, ergometrine) following PPH prophylaxis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Additional blood loss of = 500 ml | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional blood loss of = 1000 ml;Additional blood loss of = 500 ml OR use of additional uterotonic(s);Use of surgical procedure(s) related to PPH (uterine balloon tamponade, laparotomy for either compressive sutures, artery ligation or hysterectomy);Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment;Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which persists for longer than 10 minutes;Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which results in cardiac arrest;Amount of blood loss;Use of additional uterotonics;Use of blood transfusion products;Admission to Intensive care unit (ICU);Maternal Death;Clinically defined coagulopathy;Breastfeeding;Occurrence of shock;frequency and severity of AE and SAE;Composite outcome of maternal death or severe morbidity;Composite outcome of maternal death or severe morbidity;Any haemodynamic change requiring therapeutic intervention;use of additional uterotonic(s) | — |
Countries
Kenya, Nigeria, Uganda
Contacts
Public ContactMariana Widmer
Technical Officer
Outcome results
None listed