Complications; Cesarean Section
Conditions
Brief summary
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.
Detailed description
This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.
Interventions
DEVICEHem-Avert
Application of Hem-Avert
Sponsors
Stetrix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is scheduled for vaginal delivery. * Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form. * Subjects' pre-natal examination indicates that this is to be a single birth delivery.
Exclusion criteria
* Subject's scheduled for vaginal delivery with anticipated complications. * Subject is unable to understand and sign the informed consent form. * Subject does not deliver at study facility (hospital).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduce C-section Rate | 24 hours | The primary objective (purpose) of this study is to evaluate the success rate of the HEM-AVERT® device as a method of reducing C-section rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduce duration of 2nd stage of labor. | 24 hours | A secondary objective is to evaluate the success rate of the HEM-AVERT® device as a method of reducing the duration of second stage of labor |
Countries
United States
Outcome results
None listed