Perineal TearPhase 2NCT01533467
A Device Designed to Protect the Perineum During Labor
A Phase 2 study testing Perineal protection device in people with Perineal Tear, run by Helsingborgs Hospital at 1 site in Sweden.
Trial summary
Objective: To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth. Design: A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perineal Tear
- What is being tested?
- Perineal protection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Nov 2011
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Vaginal delivery
Who cannot join
- Age below 18 years and no understanding of written and oral information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Perineal Protection Device
Objective:
To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
Design:
A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.
Main outcome measures:
The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.
Read the detailed description
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
- Conditions
- Perineal Tear
- Being tested
- Perineal protection device
- Keywords
- Delivery rupture, perineal protection device, reduce perineal tears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal protection deviceDevice
Also called Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden
Use of the device during delivery and inspection afterwards to see the tears.
| Study group | Role | What they receive |
|---|---|---|
| Perineal device used | Other | Use of the perineal device during delivery Receives: Device: Perineal protection device |
| No intervention | No intervention | Controls, delivered as normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade I and II rupture during delivery
Number and extension of perineal tears during delivery
Measured: time at the delivery department (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionNov 2011
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 Perineal TearStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsingborgs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital, Skane University Hospital
- Responsible party
- Principal investigator, Knut Haadem, Helsingborgs Hospital
- Investigators
- Knut Haadem, MD, PhD, Principal investigator, Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533467
- Sponsor's protocol ID
- KH-HBG-12
- Other IDs
- 148/2008
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavesson T, Griph ID, Skarvad A, Karlsson AS, Nilsson HB, Steinvall M, Haadem K. A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:10-4. doi: 10.1016/j.ejogrb.2014.07.006. Epub 2014 Jul 30.
PubMed 25126978
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Perineal Protection Device
- ClinicalTrials.gov ID
- NCT01533467
- Acronym / sponsor ID
- KH-HBG-12
- Conditions
- Perineal Tear
- Keywords
- Delivery rupture, perineal protection device, reduce perineal tears
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Helsingborgs HospitalUniversity, hospital or other
- Collaborators
- Lund University Hospital, Skane University Hospital
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Feb 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.
Objective:
To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
Design:
A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.
Main outcome measures:
The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.
Detailed description
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal device used | Other | Device: Perineal protection deviceUse of the perineal device during delivery |
| No intervention | No intervention | –Controls, delivered as normal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Vaginal delivery
Key exclusion criteria (1 listed)
- Age below 18 years and no understanding of written and oral information.
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 |
|---|---|---|
| Perineal protection deviceAlso: Manufacturer; Calle Gejde AB, 234 21 Lomma, SwedenUse of the device during delivery and inspection afterwards to see the tears. | Device | Perineal device used |
Primary outcome
Grade I and II rupture during delivery
Time frame: time at the delivery department (up to 12 months)
Number and extension of perineal tears during delivery
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 15 Feb 2012.
- Derived from this study: PubMed 25126978Lavesson T, Griph ID, Skarvad A, Karlsson AS, Nilsson HB, Steinvall M, Haadem K. A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:10-4. doi: 10.1016/j.ejogrb.2014.07.006. Epub 2014 Jul 30.
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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.
Knut Haadem, MD, PhD principal investigator
Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perineal protection device in people with Perineal Tear, run by Helsingborgs Hospital at 1 site in Sweden.
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 15 Feb 2012. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Grade I and II rupture during delivery (time frame: time at the delivery department (up to 12 months)). 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 NCT01533467, 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 15 Feb 2012.