A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 µg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway

Background: Both oxytocin and carbetocin are used to prevent uterine atony post-partum haemorrhage after caesarean delivery in many countries, including Norway. Oxytocin causes dose-dependent ST-depression, troponin release, prolongation of QT-time arrythmia, but little is known about myocardial effects carbetocin. We have previously demonstrated comparable vasodilatory now undertaking a Phase 4 trial investigate whether similar changes markers compared with oxytocin. Methods: Our randomized controlled will be conducted at three obstetrics units Oslo University Hospital Akershus Hospital, Planned enrolment 240 healthy, singleton pregnant women aged 18 50 years undergoing planned delivery. Based on pilot study data, each participant receive one-minute intravenous injection either 2.5 IU or 100 µg during The prespecified primary outcome the change from baseline high-sensitive I plasma concentrations 6–10 hours drug administration. Secondary outcomes include tone grade five minutes administration, adverse events for up 48 estimated blood loss within eight delivery, need rescue treatment direct/indirect costs. Enrolment analysis expected completed by end 2021. Discussion: Women should assessed cardiovascular risk particularly as an obstetric history pregnancy induced hypertension, gestational diabetes mellitus, preterm birth, placental abruption, stillbirth increased future disease. Any additional ischaemic uterotonic agents balanced benefit reducing postpartum haemorrhage. potential cardiotoxicity difference between help inform decisions women. Registration: Clinicaltrials.gov NCT03899961 (02/04/2019).