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Video Analysis of Vaginal Deliveries

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT02295904
Collaborator
(none)
120
Enrollment
1
Location
46
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum
    Study Start Date :
    Feb 1, 2015
    Actual Primary Completion Date :
    Dec 1, 2017
    Actual Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. adequate support of perineum [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Zurich, Division of Obstetrics Zurich ZH Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Principal Investigator: Nina Kimmich, MD, University Hospital Zurich, Division of Obstetrics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02295904
    Other Study ID Numbers:
    • KEK-ZH-Nr.2014-0414
    First Posted:
    Nov 20, 2014
    Last Update Posted:
    Mar 18, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by University of Zurich
    perineum
    videoanalysis
    Additional relevant MeSH terms:
    Birth Injuries

    Study Results

    No Results Posted as of Mar 18, 2020