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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peisner device | Device | The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessment was done after the delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.
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| Name | Affiliation | Role |
|---|---|---|
| David B Peisner, MD | Pinnacle Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21684515 | Derived | 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. |
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Due to the nature of the equipment, if a midwife or obstetrician was planning a bed delivery rather than using stirrups, the patient is excluded.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Delivery Force Study Patients | This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Delivery Force Study Patients | This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Jun 2010 | Mean | Standard Deviation | ounces | Assessment was done after the delivery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delivery Force Study Patients | This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device failure | Pregnancy, puerperium and perinatal conditions | Since this study was observational, since the device did not affect clinical care nor touch the patient, the only potential adverse event for the study would have been device failure. The device did not fail. Therefore, there was no adverse event. |
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The trial was limited to singleton term pregnancy (37-42 weeks) patients in active labor. The study was only designed to prove that the device works and not to determine the normal range of force exerted on a fetus as it was delivered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David B. Peisner MD | Pinnacle Health | 717-231-8472 | dpeisner@pinnaclehealth.org |
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No biospecimens
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 10 |
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| 10 |
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