N/A
N=10
Demonstration of a New Device to Measure the Force of Delivering a Baby
Full Term Singleton Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00964444 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Force Exerted on a Fetus as the Delivery Occurs — 274.5 ounces
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peisner device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pinnacle Health System
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Force Exerted on a Fetus as the Delivery Occurs |
274.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pregnancy at term
- Singleton gestation
- Vertex presentation
Exclusion Criteria
- Non-reassuring fetal heart rate tracing
Data sourced from ClinicalTrials.gov (NCT00964444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.