Full Term Singleton Pregnancy
Conditions
Keywords
Labor and delivery, Vaginal delivery
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).
Interventions
DEVICEPeisner device
The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
Sponsors
Pinnacle Health System
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnancy at term * Singleton gestation * Vertex presentation
Exclusion criteria
* Non-reassuring fetal heart rate tracing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Delivery Force Study Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 25.6 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: Assessment was done after the delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delivery Force Study Patients | Force Exerted on a Fetus as the Delivery Occurs | 274.5 ounces | Standard Deviation 107.8 |