Complications; Cesarean SectionNCT01739543
A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
A study testing Hem-Avert in people with Complications; Cesarean Section, run by Stetrix, Inc. at 1 site in United States.
Trial summary
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- Hem-Avert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jan 2013
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Niagara Falls Memorial Medical Center
Niagara Falls, New York, 14301
About this study
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.
Read the 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.
- Conditions
- Complications; Cesarean Section
- Being tested
- Hem-Avert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hem-AvertDevice
Also called Hem-Avert Perianal Stabilizer
Application of Hem-Avert
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Subject receives Hem-Avert Device. Receives: Device: Hem-Avert |
| Control | No intervention | Subject does not receive Hem-Avert Device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce C-section Rate
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
Measured: 24 hours
Secondary outcomes (1)
Reduce duration of 2nd stage of labor.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications; 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
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stetrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Burns, M.D., Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739543
- Sponsor's protocol ID
- PB_002
- Status last verified
- Mar 2013
- First submitted
- 29 Nov 2012
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Burns DA. Effectiveness of a novel device in the reduction of cesarean deliveries. ISRN Obstet Gynecol. 2013 Sep 1;2013:173278. doi: 10.1155/2013/173278. eCollection 2013.
PubMed 24078876
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
- ClinicalTrials.gov ID
- NCT01739543
- Acronym / sponsor ID
- PB_002
- Conditions
- Complications; Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Stetrix, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Dec 2012 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: Hem-AvertSubject receives Hem-Avert Device. |
| Control | No intervention | –Subject does not receive Hem-Avert Device. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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-AvertAlso: Hem-Avert Perianal StabilizerApplication of Hem-Avert | Device | Investigational |
Primary outcome
Reduce C-section Rate
Time frame: 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
1 secondary outcome
Reduce duration of 2nd stage of labor.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
- Derived from this study: PubMed 24078876Burns DA. Effectiveness of a novel device in the reduction of cesarean deliveries. ISRN Obstet Gynecol. 2013 Sep 1;2013:173278. doi: 10.1155/2013/173278. eCollection 2013.
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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.
Dan Burns, M.D. principal investigator
Unafilliated
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 in people with Complications; 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Mar 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduce C-section Rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739543, which also lists 1 linked publication.
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 18 Mar 2013.