An open label, phase II, un-randomised trial of a novel medical device to manage post-partum haemorrhage, with historical controls

niversity of Liverpool0 个研究点目标入组 57 人开始时间: 2017年9月11日最近更新: 2023年3月27日

适应症

试验速览

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36732101/ (added 03/02/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36906411/ Economic evaluation (added 13/03/2023)

•1. Women with PPH following vaginal birth which is unresponsive to first line management (usually intravenous or intramuscular oxytocin +/- ergometrine)
•2. Aged over 16

•1. Women assessed antenatally to have learning difficulties that may have the potential to impair their decision making
•2. Women aged < 16 years of age
•3. Women who cannot read or understand the level of English used in the study documentation
•4. Women whose baby is stillborn
•5. Women whose PPH occurs more than 24 hours following birth
•6. Women who have undergone Female Genital Mutilation/vaginal surgery which is unreversed (assessed antenatally)
•7. Women with clotting disorders; either longstanding or following intrapartum events
•8. Women in whom the third stage of labour is not complete (placenta remains in situ) or who had a retained placenta of over 30 minutes
•9. Women who have had a caesarean section
•10. Women who have fainted or who are unconscious (including those under anaesthetic) during the PPH
•11. Women whose PPH is clinically diagnosed after 1 hour of baby’s birth

发起方

niversity of Liverpool