Laerdal Safe Vacuum (LSV) – To Save Lives, Time and Resources

Offentlig prosjektsammendrag

Background Global progress in reducing deaths of mothers and newborns have flatlined. There are now 4.5 million women and children dying every year before, during and after birth. A majority of these deaths are due to obstetric complications and can be reduced by improving the quality of care around the time of birth. Cesarean section (CS) is perceived to be safe for fetal distress or prolonged labor. However, it is estimated that 5 billion people do not have access to safe surgery, including C-sections. The risk of maternal death in women undergoing a CS is as high as 10.9 per 1000 in sub- Saharan Africa. Perinatal mortality rates of 85/1000 CS has also been reported. Although CS can be and lifesaving intervention, it is important to avoid unnecessary C-sections. In a global perspective, CS is over-used and vacuum assisted deliveries (VAD) under-used. Re-introduction of VAD has been recommended based on recent successes in Uganda, Mozambique, Tanzania and Papua New Guinea. A birth well monitored and documented with proper indications forms the best basis for timely obstetric interventions and hence might avoid asphyxiated babies and unnecessary C-sections. Intervention Labor management is not about what is measured, but what is done with the information. Laerdal Safe Vaccum (LSV) includes a novel fetal monitor connected with software designed to support midwives and doctors in the hours before a baby is born. It eases the burden of monitoring and reporting while providing decision support for lifesaving interventions. LSV will help hospitals towards a more proactive management of labor. In labors where an expedited delivery is needed, LSV will help with indications and triage towards more use of VAD births and less use of CS. A main R&D challenge is to support behaviour change and improve outcomes in places where resources are limited. Formative, feasibility and acceptability research will inform development before a clinical trial on effectiveness and safety.