NCT01277588

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 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

Study Start

First participant enrolled

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

January 14, 2011

Last Update Submit

January 16, 2012

Conditions

QuestionnaireFetal Scalp Sampling

Keywords

fetal scalp samplingexperience questionnaire

Study Arms (2)

Patient

Physcician

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • fetal scalp sampling during labor

You may not qualify if:

  • non-proficiency in the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of obstetrics and gynecology

Uppsala, Sweden

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D. Consultant

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

SE(1)