The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates. By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Composite neonatal brain damage
Timeframe: From start of extraction through 28 days after delivery (or until discharge from the hospital)