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

NCT ID: NCT00964444

Last Updated: 2010-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Full Term Singleton Pregnancy

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Peisner platform

Eligibility Criteria

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Inclusion Criteria

* Pregnancy at term
* Singleton gestation
* Vertex presentation

Exclusion Criteria

* Non-reassuring fetal heart rate tracing
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pinnacle Health System

OTHER

Sponsor Role lead

Responsible Party

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Pinnacle Health

Principal Investigators

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David B Peisner, MD

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Health System

Locations

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Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21684515 (View on PubMed)

Other Identifiers

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6684165DP01

Identifier Type: -

Identifier Source: org_study_id

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