Vaginal TearPhase 3NCT04370340
Application of a Perineal Protection Device in Vacuum-assisted Births
A Phase 3 study testing BabySlide in people with Vaginal Tear and Perineal Tear, run by University of Zurich at 1 site in Switzerland.
Trial summary
Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Tear, Perineal Tear
- What is being tested?
- BabySlide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2020to 30 Sep 2022
- Phase
- Phase 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Schwangere Frauen ab 18 Jahren
- Schwangerschaftsalter ab 36+0 SSW bei Geburt
- Einlingsschwangerschaft
- Schädellage des Kindes bei Geburt
- Anstreben einer Vaginalgeburt am USZ
- Geburtsbeendigung per Vakuumextraktion (Saugglocke)
- Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung (ausreichende Deutsch- bzw. Englischkenntnisse)
Who cannot join
- - Geburtsbeendigung per Spontangeburt, Forcepsextraktion (Zange) oder Sectio caesarea (Kaiserschnitt)
- Maternale Erkrankung des Bindegewebes (z.B. Kollagenosen)
- Äusserliche fetale Fehlbildungen, die den Geburtsablauf und die Grössenverhältnisse von Kind zu Geburtskanal verändern
- Intrauteriner Fruchttod des Kindes
- Vaginale, perineale und/oder vulväre Voroperationen (ausser Naht von Geburtsverletzungen)
- St.n. Beckenboden-Operation oder Inkontinenz-Operation
Show all 9Show fewer
- St.n. Infibulation
- Anwendung des EPI-NO® Dammtrainers während der Schwangerschaft
- Bekannte Allergien gegenüber einem der Inhaltsstoffe des BabySlide®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial
Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support. The medical device "BabySlide®" was developed as an auxilliary device for perineal support and already evaluated in a multicenter randomized controlled trial in Schweden in pregnant women during vaginal birth. It could be seen, that the application of the device significantly reduced the rate of vagibal tears and low-grade perineal tearsin the intervention group (with application of the BabySlide®) in contrast to the controlo group (without application of the BabySlide®) by about 10%. In this study, solely 10% of births were ended by vacuum assistance. However, birth tears appear much more often in vacuum-assisted births than in normal spontaneous births. Therefore, the aim of this study is to evaluate the application of the device explicitly in vacuum-assisted births and to investigate if the application should be recommende in vacuum extractions in general in the future.
- Conditions
- Vaginal Tear, Perineal Tear
- Being tested
- BabySlide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabySlideDevice
Application of BabySlide during vacuum-assisted births for perineal protection
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| intervention | Active comparator | Not described Receives: Device: BabySlide |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of vaginal tears
assessment of the rate of vaginal tears in the posterior compartment by inspection
Measured: at day of birth
rate of low-grade perineal tears
assessment of the rate of low-grade perineal tears by inspection
Measured: at day of birth
Secondary outcomes (5)
rate of high-grade perineal tears
assessment of the rate of high-grade perineal tears by inspection
Measured: at day of birth
Maternal adverse effects
assessment of maternal adverse effects of the BabySlide by medical staff
Measured: within 1-4 days after birth
Fetal adverse effects
assessment of fetal adverse effects of the BabySlide by medical staff
Measured: within 1-4 days after birth
Maternal comfort with the BabySlide
Assessment of maternal comfort with the BabySlide by a questionnaire
Measured: within 1-4 days after birth
User abilitiy
Assessment of the user ability of the BabySlide by a questionnaire
Measured: directly after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Aug 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal TearStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Kimmich, Dr., Principal investigator, University Hospital Zurich, Department od Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370340
- Sponsor's protocol ID
- PeriProtectTrial
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04370340
- Acronym / sponsor ID
- PeriProtectTrial
- Conditions
- Vaginal Tear, Perineal Tear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 30 Apr 2020 (actual)
- 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.
Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support. The medical device "BabySlide®" was developed as an auxilliary device for perineal support and already evaluated in a multicenter randomized controlled trial in Schweden in pregnant women during vaginal birth. It could be seen, that the application of the device significantly reduced the rate of vagibal tears and low-grade perineal tearsin the intervention group (with application of the BabySlide®) in contrast to the controlo group (without application of the BabySlide®) by about 10%. In this study, solely 10% of births were ended by vacuum assistance. However, birth tears appear much more often in vacuum-assisted births than in normal spontaneous births. Therefore, the aim of this study is to evaluate the application of the device explicitly in vacuum-assisted births and to investigate if the application should be recommende in vacuum extractions in general in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| intervention | Active comparator | Device: BabySlide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Schwangere Frauen ab 18 Jahren
- Schwangerschaftsalter ab 36+0 SSW bei Geburt
- Einlingsschwangerschaft
- Schädellage des Kindes bei Geburt
- Anstreben einer Vaginalgeburt am USZ
Key exclusion criteria (9 listed)
- - Geburtsbeendigung per Spontangeburt, Forcepsextraktion (Zange) oder Sectio caesarea (Kaiserschnitt)
- Maternale Erkrankung des Bindegewebes (z.B. Kollagenosen)
- Äusserliche fetale Fehlbildungen, die den Geburtsablauf und die Grössenverhältnisse von Kind zu Geburtskanal verändern
- Intrauteriner Fruchttod des Kindes
- Vaginale, perineale und/oder vulväre Voroperationen (ausser Naht von Geburtsverletzungen)
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 |
|---|---|---|
| BabySlideApplication of BabySlide during vacuum-assisted births for perineal protection | Device | intervention |
Primary outcome
rate of vaginal tears
Time frame: at day of birth
assessment of the rate of vaginal tears in the posterior compartment by inspection
rate of low-grade perineal tears
Time frame: at day of birth
assessment of the rate of low-grade perineal tears by inspection
5 secondary outcomes
rate of high-grade perineal tears
Time frame: at day of birth
Maternal adverse effects
Time frame: within 1-4 days after birth
Fetal adverse effects
Time frame: within 1-4 days after birth
Maternal comfort with the BabySlide
Time frame: within 1-4 days after birth
User abilitiy
Time frame: directly after the procedure
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 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Nina Kimmich, Dr. principal investigator
University Hospital Zurich, Department od Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BabySlide in people with Vaginal Tear and Perineal Tear, run by University of Zurich at 1 site in Switzerland.
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 7 inclusion and 9 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 2 Nov 2022. 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 Switzerland. 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 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?
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?
rate of vaginal tears (time frame: at day of birth). The study lists 2 primary outcomes in all. 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 2 Nov 2022.