Perineal Tears.Phase 2/3NCT02013752
The Effect of the Modified Perineal Protection Device During Delivery
A Phase 2/3 study testing Perineal protection device. in people with Perineal Tears., run by Knut Haadem at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perineal Tears.
- 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
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 2/3
- 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 at term (week 36 - 41)
Who cannot join
- Age below 18
- Breech delivery
- Not understanding written and oral information
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept Obstetrics and Gynecology, Helsingborg Hospital
Helsingborg, Skåne County, 20587
Knut Haadem, MD, PhD, 0046739549946, knut.haadem@telia.com
Tony Lavesson, MD, 0046424062205, tony.lavesson@skane.se
About this study
Official title: Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.
Read the detailed description
RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.
- Conditions
- Perineal Tears.
- Being tested
- Perineal protection device.
- Keywords
- Delivery tears, Birth injuries, Perineal protection device
- Medical subject headings
- Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal protection device.Device
Also called The perineal protection device have no brand name.
A device used to reduce perineal tears during delivery of the baby.
| Study group | Role | What they receive |
|---|---|---|
| Perineal device during delivery | Active comparator | Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the "tongue" was inserted between the head and the posterior vaginal wall and the "two wings" were held against the perineum and kept in place by the delivery attendant's hand. Receives: Device: Perineal protection device. |
| Standard care | Other | Standard care at delivery: Manual support of the perineum Receives: Device: Perineal protection device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of delivery tear measured in cm with ruler
The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery.
Measured: at delivery - Participants will be followed for the duration of the first 24 hours
Secondary outcomes (1)
Adverse effects of the device on mother and child
Measure eventual adverse effects on mother and child.
Measured: at delivery-Participants will be followed for the duration of the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMar 2015
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
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 Tears.Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Knut Haadem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Knut Haadem, Helsingborgs Hospital
- Investigators
- Knut Haadem, M.D., PhD, Principal investigator, Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013752
- Sponsor's protocol ID
- KH-HBG-13
- Other IDs
- ONLY-HBG
- Status last verified
- Mar 2015
- First submitted
- 1 Dec 2013
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Andre K, Leijonhufvud A, Ignell C, Kallen K, Stuart A. Minimizing tearing during vaginal delivery with a perineal protection device: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Sep;6(9):101402. doi: 10.1016/j.ajogmf.2024.101402. Epub 2024 Jun 15.
PubMed 38880240
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device
- ClinicalTrials.gov ID
- NCT02013752
- Acronym / sponsor ID
- KH-HBG-13
- Conditions
- Perineal Tears.
- Keywords
- Delivery tears, Birth injuries, Perineal protection device
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Knut HaademUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Dec 2013 (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.
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.
Detailed description
RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal device during delivery | Active comparator | Device: Perineal protection device.Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the "tongue" was inserted between the head and the posterior vaginal wall and the "two wings" were held against the perineum and kept in place by the delivery attendant's hand. |
| Standard care | Other | Device: Perineal protection device.Standard care at delivery: Manual support of the perineum |
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 at term (week 36 - 41)
Key exclusion criteria (3 listed)
- Age below 18
- Breech delivery
- Not understanding 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 device.Also: The perineal protection device have no brand name.A device used to reduce perineal tears during delivery of the baby. | Device | Perineal device during delivery, Standard care |
Primary outcome
Length of delivery tear measured in cm with ruler
Time frame: at delivery - Participants will be followed for the duration of the first 24 hours
The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery.
1 secondary outcome
Adverse effects of the device on mother and child
Time frame: at delivery-Participants will be followed for the duration of the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Derived from this study: PubMed 38880240Andre K, Leijonhufvud A, Ignell C, Kallen K, Stuart A. Minimizing tearing during vaginal delivery with a perineal protection device: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Sep;6(9):101402. doi: 10.1016/j.ajogmf.2024.101402. Epub 2024 Jun 15.
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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, M.D., PhD principal investigator
Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, 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 2/3 study testing Perineal protection device. in people with Perineal Tears., run by Knut Haadem 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 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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Knut Haadem, M.D. PhD (0046739549946, knut.haadem@telia.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of delivery tear measured in cm with ruler (time frame: at delivery - Participants will be followed for the duration of the first 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 NCT02013752, 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 19 Mar 2015.