Cesarean SectionNCT02167438
Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer
A study testing Hem-Avert Perianal Stabilizer in people with Cesarean Section, run by Stetrix, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Hem-Avert Perianal Stabilizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Subject unable to speak English
- 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
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- Multiple Gestation
- PROM (premature rupture of membranes)
- Previous Cesarean Section
- PTL (preterm labor)
- Known major fetal anomaly or fetal demise.
- Suspected or proven chorioamnionitis
- Placenta previa
- Maternal insulin dependent diabetes
- Maternal health conditions deemed as risk factors by investigators such as renal or cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Women may sometimes be reluctant to push resulting in a prolonged second stage labor, which could lead to a Cesarean section. This study will record the frequency of Cesarean sections in two groups to determine if there are any measurable differences.
The investigational device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This device has received previous FDA clearance as a Class II device to prevent hemorrhoids during childbirth. This study is being conducted by Stetrix, Inc. and falls within the guidelines set forth by the Food and Drug Administration in 21 CFR Section 812.2 as a non-significant risk study. The HEM-AVERT® Perianal Stabilizer is a Class II device in accordance with FDA regulation 21 CFR 890.5765. The Class II version of the device and the investigational device are identical in terms of materials, design, intended population and area used. The sole difference is that data will be collected in order to support an application to the FDA to obtain clearance of the device for the specific claim of reducing the C-section rate and/or reducing the second stage of labor times. This difference in data collection may be viewed as off-label use of the device although there is no new risk to the subject in the use of this device as an investigational device.
The primary objective of this study is to reduce the C-section rate and/or the second stage of labor times while using this device. For patients scheduled for a vaginal delivery, success is defined as completing the vaginal delivery process.
- Conditions
- Cesarean Section
- Being tested
- Hem-Avert Perianal Stabilizer
- Keywords
- Cesarean, Section, second, stage, labor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hem-Avert Perianal StabilizerDevice
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Application of the Hem-Avert device. Receives: Device: Hem-Avert Perianal Stabilizer |
| Control | No intervention | No Application of the Hem-Avert device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the reduction in Cesarean section rates.
This study is a single-site, prospective, randomized, concurrently-controlled study. Subjects will undergo screening to determine their enrollment eligibility. All subjects who meet inclusion criteria will be offered participation in this study.
Measured: 12 Months
Secondary outcomes (1)
Measuring the reduction of second-stage of labor times.
This is a single-site, prospective, randomized concurrently controlled study. Subjects will undergo screening to determine their enrollment eligibility. All subjects who meet inclusion criteria will be offered participation in the study.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stetrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167438
- Sponsor's protocol ID
- PB_004
- Status last verified
- Mar 2017
- First submitted
- 17 Jun 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer
- ClinicalTrials.gov ID
- NCT02167438
- Acronym / sponsor ID
- PB_004
- Conditions
- Cesarean Section
- Keywords
- Cesarean, Section, second, stage, labor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Stetrix, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women may sometimes be reluctant to push resulting in a prolonged second stage labor, which could lead to a Cesarean section. This study will record the frequency of Cesarean sections in two groups to determine if there are any measurable differences.
The investigational device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This device has received previous FDA clearance as a Class II device to prevent hemorrhoids during childbirth. This study is being conducted by Stetrix, Inc. and falls within the guidelines set forth by the Food and Drug Administration in 21 CFR Section 812.2 as a non-significant risk study. The HEM-AVERT® Perianal Stabilizer is a Class II device in accordance with FDA regulation 21 CFR 890.5765. The Class II version of the device and the investigational device are identical in terms of materials, design, intended population and area used. The sole difference is that data will be collected in order to support an application to the FDA to obtain clearance of the device for the specific claim of reducing the C-section rate and/or reducing the second stage of labor times. This difference in data collection may be viewed as off-label use of the device although there is no new risk to the subject in the use of this device as an investigational device.
The primary objective of this study is to reduce the C-section rate and/or the second stage of labor times while using this device. For patients scheduled for a vaginal delivery, success is defined as completing the vaginal delivery process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: Hem-Avert Perianal StabilizerApplication of the Hem-Avert device. |
| Control | No intervention | –No Application of the Hem-Avert device. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Subject unable to speak English
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hem-Avert Perianal Stabilizer | Device | Investigational |
Primary outcome
Measuring the reduction in Cesarean section rates.
Time frame: 12 Months
This study is a single-site, prospective, randomized, concurrently-controlled study. Subjects will undergo screening to determine their enrollment eligibility. All subjects who meet inclusion criteria will be offered participation in this study.
1 secondary outcome
Measuring the reduction of second-stage of labor times.
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hem-Avert Perianal Stabilizer in people with Cesarean Section, run by Stetrix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the reduction in Cesarean section rates. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.