An observational study in Full Term Singleton Pregnancy, sponsored by Pinnacle Health System. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-19.
Sponsored by Pinnacle Health System · Observational
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.
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).
Pinnacle Health System is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.
Exclusion Criteria:
The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
Also known as: Peisner platform
Force Exerted on a Fetus as the Delivery Occurs
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.
Time frame: Assessment was done after the delivery
Pregnant patients at term in early labor with a singleton vertex fetus and anticipated vaginal delivery are recruited in the labor \& delivery suite of Harrisburg Hospital for this study
| Milestone | Delivery Force Study Patients |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| ounces | Delivery Force Study Patients |
|---|---|
| Force Exerted on a Fetus as the Delivery Occurs | 274.5 ± 107.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Delivery Force Study Patients | — | 0/10 (0%) | 0/10 (0%) |
| Event | Delivery Force Study Patients |
|---|---|
| Device failurePregnancy, puerperium and perinatal conditions | 0/10 |
| Age, Categorical(Participants) | Delivery Force Study Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age Continuous(years) | Delivery Force Study Patients |
|---|---|
| Mean | 25.6 ± 4.4 |
| Sex: Female, Male(Participants) | Delivery Force Study Patients |
|---|---|
| Female | 10 |
| Male | 0 |
| Region of Enrollment(participants) | Delivery Force Study Patients |
|---|---|
| United States | 10 |
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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