Demonstration of a New Device to Measure the Force of Delivering a Baby
1 other identifier
observational
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
August 19, 2010
CompletedAugust 19, 2010
July 1, 2010
5 months
August 24, 2009
June 17, 2010
July 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Force Exerted on a Fetus as the Delivery Occurs
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.
Assessment was done after the delivery
Interventions
The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
Eligibility Criteria
Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.
You may qualify if:
- Pregnancy at term
- Singleton gestation
- Vertex presentation
You may not qualify if:
- Non-reassuring fetal heart rate tracing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harrisburg Hospital
Harrisburg, Pennsylvania, 17101, United States
Related Publications (1)
Peisner DB. A device that measures the pulling force and vector of delivering a baby. Am J Obstet Gynecol. 2011 Sep;205(3):221.e1-7. doi: 10.1016/j.ajog.2011.04.029. Epub 2011 Apr 24.
PMID: 21684515DERIVED
Biospecimen
No biospecimens
Limitations and Caveats
The trial was limited to singleton term pregnancy (37-42 weeks) patients in active labor. The study was only designed to prove that the device works and not to determine the normal range of force exerted on a fetus as it was delivered.
Results Point of Contact
- Title
- David B. Peisner MD
- Organization
- Pinnacle Health
Study Officials
- PRINCIPAL INVESTIGATOR
David B Peisner, MD
Pinnacle Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 25, 2009
Study Start
April 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
August 19, 2010
Results First Posted
August 19, 2010
Record last verified: 2010-07