Trial Outcomes & Findings for Demonstration of a New Device to Measure the Force of Delivering a Baby (NCT NCT00964444)
NCT ID: NCT00964444
Last Updated: 2010-08-19
Results Overview
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.
COMPLETED
10 participants
Assessment was done after the delivery
2010-08-19
Participant Flow
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
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Demonstration of a New Device to Measure the Force of Delivering a Baby
Baseline characteristics by cohort
| Measure |
Delivery Force Study Patients
n=10 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age Continuous
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25.6 years
STANDARD_DEVIATION 4.4 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Assessment was done after the deliveryThe 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.
Outcome measures
| Measure |
Delivery Force Study Patients
n=10 Participants
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.
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|---|---|
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Force Exerted on a Fetus as the Delivery Occurs
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274.5 ounces
Standard Deviation 107.8
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Adverse Events
Delivery Force Study Patients
Serious adverse events
| Measure |
Delivery Force Study Patients
n=10 participants at risk
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.
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|---|---|
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Pregnancy, puerperium and perinatal conditions
Device failure
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0.00%
0/10
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place