Video Analysis of Vaginal Deliveries

Birth Trauma Clinical Trial

Official title:

Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295904
• Other study ID #: KEK-ZH-Nr.2014-0414
• Status: Completed
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Injuries
• Birth Trauma

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Obstetrics	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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