Demonstration of a New Device to Measure the Force of Delivering a Baby
This study is an observational study to prove that a new device, which measures the force of delivering a baby, (US patent 6,684,165) functions as described in the patent. This is the first time this has been used with patients.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Demonstration of a New Device to Measure the Force of Delivering a Baby|
- Force Exerted on a Fetus as the Delivery Occurs [ Time Frame: Assessment was done after the delivery ] [ Designated as safety issue: Yes ]The amount of force exerted on the fetus was measured in ounces. It was calculated based on measurements from the force transducers in the platform. The obstetrician stands or sits on the platform as the infant is delivered.
Biospecimen Retention: None Retained
|Study Start Date:||April 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Device: Peisner device
Currently, there is no way to measure how hard a doctor or midwife pulls when a baby is delivered. This device is a platform with special sensors. The doctor or midwife stands/sits on the platform while delivering the baby, and using a simple physical principle: for every action, there is an equal an opposite reaction. Prior to building the prototype and starting the study, the system and concept has been patented (US patent 6,684,165). In reality, this is not really a medical device since it does not touch the patient and does not have any effect on the delivery itself. It is merely a new type of external observation of the delivery of a baby that happens to produce useful information (the force that is exerted when the baby is delivered).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964444
|United States, Pennsylvania|
|Harrisburg, Pennsylvania, United States, 17101|
|Principal Investigator:||David B Peisner, MD||Pinnacle Health System|