Cesarean Section RateNCT02562547
Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice
An observational study of Cesarean Section Rate, run by Desert Perinatal Associates.
Trial summary
This is a retrospective data-only study following the phased introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in labor and delivery settings in the hospital of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Rate
- What is being tested?
- Hem-Avert Perianal Stabilizer
- Type of treatment
- Medical device
- How many people
- 799 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 2015
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be all women who present for vaginal delivery at Dignity Health - St. Rose, Siena Campus during the 3 month study period. The main focus of this study is to see whether the Hem-Avert® reduces Cesarean delivery among women undergoing labor and delivery. To be included in this study, by definition, the participant must be a pregnant woman.
Who may be able to join
- Vaginal Births
Who cannot join
- Anticipated non-vaginal birth
About this study
This is a retrospective data-only study following the phased introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean Section during labor and delivery.
Read the detailed description
The on label device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This study is being sponsored by Dignity Health 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 801.109. Retrospective data will be collected in this study on the reduction of c-section rates and duration of second stage of labor. These data may be used to support an application to the FDA for a new indication of reducing c-sections. It is also possible the second stage labor data may also be used in support of expanded labeling.
- Conditions
- Cesarean Section Rate
- Being tested
- Hem-Avert Perianal Stabilizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hem-Avert Perianal StabilizerDevice
The HEM-AVERT® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERT® Perianal Stabilizer is a non-invasive device used to help provide continuous pressure to the perianal region as a means to help provide support during the labor process.
| Study group | Role | What they receive |
|---|---|---|
| All Vaginal Births | The application of the Hem-Avert Perianal Stabilizer Receives: Device: Hem-Avert Perianal Stabilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Conversion Rate
Cesarean Conversion Rate
Measured: 90 Days
Secondary outcomes (2)
Second stage labor times
Comparing second stage labor times
Measured: 90 Days
Lacerations
Comparing lacerations
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section RateStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desert Perinatal Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Weiner, M.D., Study chair, Dignity Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562547
- Sponsor's protocol ID
- DH-SR-S-01
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abramowitz L, Sobhani I, Benifla JL, Vuagnat A, Darai E, Mignon M, Madelenat P. Anal fissure and thrombosed external hemorrhoids before and after delivery. Dis Colon Rectum. 2002 May;45(5):650-5. doi: 10.1007/s10350-004-6262-5.
PubMed 12004215Gjerdingen DK, Froberg DG, Chaloner KM, McGovern PM. Changes in women's physical health during the first postpartum year. Arch Fam Med. 1993 Mar;2(3):277-83. doi: 10.1001/archfami.2.3.277.
PubMed 8252148Cheng CY, Li Q. Integrative review of research on general health status and prevalence of common physical health conditions of women after childbirth. Womens Health Issues. 2008 Jul-Aug;18(4):267-80. doi: 10.1016/j.whi.2008.02.004. Epub 2008 May 12.
PubMed 18468922Burns 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 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02562547
- Acronym / sponsor ID
- DH-SR-S-01
- Conditions
- Cesarean Section Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- Desert Perinatal AssociatesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Sep 2015 (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 is a retrospective data-only study following the phased introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean Section during labor and delivery.
Detailed description
The on label device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This study is being sponsored by Dignity Health 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 801.109. Retrospective data will be collected in this study on the reduction of c-section rates and duration of second stage of labor. These data may be used to support an application to the FDA for a new indication of reducing c-sections. It is also possible the second stage labor data may also be used in support of expanded labeling.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Vaginal Births | – | Device: Hem-Avert Perianal StabilizerThe application of the Hem-Avert Perianal Stabilizer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be all women who present for vaginal delivery at Dignity Health - St. Rose, Siena Campus during the 3 month study period. The main focus of this study is to see whether the Hem-Avert® reduces Cesarean delivery among women undergoing labor and delivery. To be included in this study, by definition, the participant must be a pregnant woman.
Key inclusion criteria (1 listed)
- Vaginal Births
Key exclusion criteria (1 listed)
- Anticipated non-vaginal 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 StabilizerThe HEM-AVERT® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERT® Perianal Stabilizer is a non-invasive device used to help provide continuous pressure to the perianal region as a means to help provide support during the labor process. | Device | All Vaginal Births |
Primary outcome
Cesarean Conversion Rate
Time frame: 90 Days
Cesarean Conversion Rate
2 secondary outcomes
Second stage labor times
Time frame: 90 Days
Lacerations
Time frame: 90 Days
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 29 Sep 2015.
- Background: PubMed 12004215Abramowitz L, Sobhani I, Benifla JL, Vuagnat A, Darai E, Mignon M, Madelenat P. Anal fissure and thrombosed external hemorrhoids before and after delivery. Dis Colon Rectum. 2002 May;45(5):650-5. doi: 10.1007/s10350-004-6262-5.
- Background: PubMed 8252148Gjerdingen DK, Froberg DG, Chaloner KM, McGovern PM. Changes in women's physical health during the first postpartum year. Arch Fam Med. 1993 Mar;2(3):277-83. doi: 10.1001/archfami.2.3.277.
- Background: PubMed 18468922Cheng CY, Li Q. Integrative review of research on general health status and prevalence of common physical health conditions of women after childbirth. Womens Health Issues. 2008 Jul-Aug;18(4):267-80. doi: 10.1016/j.whi.2008.02.004. Epub 2008 May 12.
- Background: 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.
Craig Weiner, M.D. study chair
Dignity Health
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Rate, run by Desert Perinatal Associates.
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 1 inclusion and 1 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Cesarean Conversion Rate (time frame: 90 Days). 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 NCT02562547, which also lists 4 linked publications.
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 29 Sep 2015.