Video Analysis of Vaginal Deliveries | NCT02295904

Studies
Video Analysis of Vaginal Deliveries

NCT02295904

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Mar 18, 2020Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Birth Trauma

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2018Actual

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Nov 17, 2014

First Posted Date

Nov 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2020

Last Update Posted Date

Mar 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina Kimmich, MD	University Hospital Zurich, Division of Obstetrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Obstetrics		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001720	Birth Injuries

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided