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

Completed

• Conditions: Full Term Singleton Pregnancy

• Registration Number: NCT00964444
• Lead Sponsor: Pinnacle Health System

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.

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-06-17
• Status Verified: 2010-07
• Results First Submitted QC: 2010-07-22
• Last Update Submitted: 2010-07-22
• Results First Posted: 2010-08-19
• Last Update Posted: 2010-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Pregnancy at term
• Singleton gestation
• Vertex presentation

Exclusion Criteria

• Non-reassuring fetal heart rate tracing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Force Exerted on a Fetus as the Delivery Occurs	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.

Trial Locations

Locations (1)

Harrisburg Hospital; 🇺🇸 Harrisburg, Pennsylvania, United States