Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial

WHO0 个研究点目标入组 6,200 人开始时间: 2023年12月21日最近更新: 2024年5月27日

试验速览

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•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.

•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.

发起方

WHO