NCT02295904

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

November 5, 2014

Last Update Submit

March 17, 2020

Conditions

Birth Trauma

Keywords

perineumvideoanalysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Obstetrics

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Birth Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Nina Kimmich, MD

    University Hospital Zurich, Division of Obstetrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 20, 2014

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

CH(1)