Harrisburg Hospital
Harrisburg, Pennsylvania, 17101, United States
Completed
NCT Number: NCT00964444
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Pregnancy at term
- Singleton gestation
- Vertex presentation
Exclusion criteria
- Non-reassuring fetal heart rate tracing
Treatment and study plan
Peisner device
DeviceThe doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
Other names: Peisner platform
Primary outcomes
-
Force Exerted on a Fetus as the Delivery Occurs
Time frame: Assessment was done after the delivery
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.
Sponsors and collaborators
Lead sponsor
Pinnacle Health System
Other
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Aug 25, 2009
- Registry last updated
- Aug 19, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.