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Demonstration of a New Device to Measure the Force of Delivering a Baby

This study has been completed.
Sponsor:
Information provided by:
Pinnacle Health System
ClinicalTrials.gov Identifier:
NCT00964444
First received: August 24, 2009
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Full Term Singleton Pregnancy
Device: Peisner device

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Demonstration of a New Device to Measure the Force of Delivering a Baby

Further study details as provided by Pinnacle Health System:

Primary Outcome Measures:
  • 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

No biospecimens


Enrollment: 10
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Peisner device
    The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
    Other Name: Peisner platform
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Pregnancy at term
  • Singleton gestation
  • Vertex presentation

Exclusion Criteria:

  • Non-reassuring fetal heart rate tracing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964444

Locations
United States, Pennsylvania
Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17101
Sponsors and Collaborators
Pinnacle Health System
Investigators
Principal Investigator: David B Peisner, MD Pinnacle Health System
  More Information

No publications provided by Pinnacle Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David B Peisner MD, Pinnacle Health
ClinicalTrials.gov Identifier: NCT00964444     History of Changes
Other Study ID Numbers: 6684165DP01
Study First Received: August 24, 2009
Results First Received: June 17, 2010
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pinnacle Health System:
Labor and delivery
Vaginal delivery

ClinicalTrials.gov processed this record on November 20, 2014