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

P

Pinnacle Health System

Status

Completed

Conditions

Full Term Singleton Pregnancy

Treatments

Device: Peisner device

Study type

Observational

Funder types

Other

Identifiers

NCT00964444
6684165DP01

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnancy at term
  • Singleton gestation
  • Vertex presentation

Exclusion criteria

  • Non-reassuring fetal heart rate tracing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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