Evaluation of the Physicians and Patients Experience of F... | NCT01277588

Studies
Evaluation of the Physicians and Patients Experience of Fetal Scalp Sampling

NCT01277588

Sponsor

Uppsala University Hospital

Status

Completed

Last Update Posted

Jan 18, 2012Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Questionnaire
Fetal Scalp Sampling

Interventions

Not provided

Countries

Sweden

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

Jan 2012

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

Aug 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jan 14, 2011

First Submission Date that Met QC Criteria

Jan 14, 2011

First Posted Date

Jan 17, 2011Estimated

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

Jan 16, 2012

Last Update Posted Date

Jan 18, 2012Estimated

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

During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test is performed with the woman in the supine position and is generally described as a difficult and cumbersome procedure.

Detailed Description

Women who were subjected to fetal scalp sampling are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the woman experienced the testing procedure.

Physicans who performed the test are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the physician experienced the testing procedure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

51Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fetal scalp sampling during labor

Exclusion Criteria:

non-proficiency in the Swedish language

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women who are subjected to fetal scalp sampling during labor Physicians performning fetal scalp sampling

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of obstetrics and gynecology		Uppsala			Sweden