- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00964444
Demonstration of a New Device to Measure the Force of Delivering a Baby
July 22, 2010 updated by: Pinnacle Health System
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17101
- Harrisburg Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.
Description
Inclusion Criteria:
- Pregnancy at term
- Singleton gestation
- Vertex presentation
Exclusion Criteria:
- Non-reassuring fetal heart rate tracing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessment was done after the delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David B Peisner, MD, Pinnacle Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
September 1, 2009
Study Registration Dates
First Submitted
August 24, 2009
First Submitted That Met QC Criteria
August 24, 2009
First Posted (ESTIMATE)
August 25, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2010
Last Update Submitted That Met QC Criteria
July 22, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6684165DP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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