Full Term Singleton PregnancyNCT00964444
Demonstration of a New Device to Measure the Force of Delivering a Baby
An observational study of Full Term Singleton Pregnancy, run by Pinnacle Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Full Term Singleton Pregnancy
- What is being tested?
- Peisner device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.
Who may be able to join
- Pregnancy at term
- Singleton gestation
- Vertex presentation
Who cannot join
- Non-reassuring fetal heart rate tracing
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Full Term Singleton Pregnancy
- Being tested
- Peisner device
- Keywords
- Labor and delivery, Vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peisner deviceDevice
Also called Peisner platform
The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment was done after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full Term Singleton PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinnacle Health System
- Sponsor type
- University, hospital or other
- Investigators
- David B Peisner, MD, Principal investigator, Pinnacle Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964444
- Sponsor's protocol ID
- 6684165DP01
- Status last verified
- Jul 2010
- First submitted
- 24 Aug 2009
- Last updated
- 19 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21684515
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of a New Device to Measure the Force of Delivering a Baby
- ClinicalTrials.gov ID
- NCT00964444
- Acronym / sponsor ID
- 6684165DP01
- Conditions
- Full Term Singleton Pregnancy
- Keywords
- Labor and delivery, Vaginal delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pinnacle Health SystemUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 19 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.
Key inclusion criteria (3 listed)
- Pregnancy at term
- Singleton gestation
- Vertex presentation
Key exclusion criteria (1 listed)
- Non-reassuring fetal heart rate tracing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peisner deviceAlso: Peisner platformThe doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby. | Device | – |
Primary outcome
Force Exerted on a Fetus as the Delivery Occurs
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21684515Peisner 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Peisner, MD principal investigator
Pinnacle Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Full Term Singleton Pregnancy, run by Pinnacle Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force Exerted on a Fetus as the Delivery Occurs (time frame: Assessment was done after the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00964444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.