Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer (NCT02167438) | Clinical Trial Compass
TerminatedNot Applicable
Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer
Stopped: Lack of enrollment
United States117 participantsStarted 2014-10
Plain-language summary
This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pregnant women between the ages of 18 and 40 years old at the time of enrollment
. Gestational age between 34 and 42 weeks at the time of enrollment
. Live singleton gestation
. Candidate for vaginal delivery.
. Willing and able to comply with the study plan as indicated by understanding and signing the subject informed consent form
Exclusion criteria
. Subject unable to speak English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measuring the reduction in Cesarean section rates.
. Subject unable to understand and sign the informed consent form
. Delivery planned outside the clinical center
. Subject is scheduled for vaginal delivery with anticipated complications (i.e. including but not limited to non-vertex presentation or macrosomia \>4,000 grams)
. Subject scheduled for an elective cesarean birth
. Preeclampsia with severe features, eclampsia, HELLP syndrome