Birth TraumaNCT02295904
Video Analysis of Vaginal Deliveries
An observational study of Birth Trauma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum 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
- Birth Trauma
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Dec 2018
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women
Who may be able to join
- Pregnant women,
- at least 18 years of age (yoa),
- term deliveries (at least 37+0 weeks of gestation),
- vaginal delivery,
- fetal vertex presentation,
- single pregnancy
Who cannot join
- younger than 18 yoa,
- preterm deliveries,
- cesarean sections,
- fetal malformations,
- maternal disease in form of collagenosis,
- multiples pregnancy,
- vaginal/vulvar/perineal pre-operations (excluding birth trauma),
- perineal birth trauma grade III+IV
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Obstetrics
Zurich, Canton of Zurich, 8091
About this study
Official title: Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum
Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum
Read the detailed description
Documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.
- Conditions
- Birth Trauma
- Keywords
- perineum, videoanalysis
- Medical subject headings
- Birth Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate support of perineum
documentation of support of perineum via video camera during delivery, documentation of birth trauma after delivery, documentation of fetal and maternal parameters as weight, hight, fetal presentation, etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth TraumaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Kimmich, MD, Principal investigator, University Hospital Zurich, Division of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295904
- Sponsor's protocol ID
- KEK-ZH-Nr.2014-0414
- Status last verified
- Mar 2020
- First submitted
- 5 Nov 2014
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum
- ClinicalTrials.gov ID
- NCT02295904
- Acronym / sponsor ID
- KEK-ZH-Nr.2014-0414
- Conditions
- Birth Trauma
- Keywords
- perineum, videoanalysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Nov 2014 (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.
Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum
Detailed description
Documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women
Key inclusion criteria (6 listed)
- Pregnant women,
- at least 18 years of age (yoa),
- term deliveries (at least 37+0 weeks of gestation),
- vaginal delivery,
- fetal vertex presentation,
Key exclusion criteria (8 listed)
- younger than 18 yoa,
- preterm deliveries,
- cesarean sections,
- fetal malformations,
- maternal disease in form of collagenosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adequate support of perineum
Time frame: 12 months
documentation of support of perineum via video camera during delivery, documentation of birth trauma after delivery, documentation of fetal and maternal parameters as weight, hight, fetal presentation, etc.
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 2020.
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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, MD principal investigator
University Hospital Zurich, Division of Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Trauma, 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 6 inclusion and 8 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 2020. 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.
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?
adequate support of perineum (time frame: 12 months). 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 18 Mar 2020.