FBS: Scalp Sampling for Fetal Surveillance

Sponsor
Uppsala University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01533701
Collaborator
Uppsala County Council, Sweden (Other)
60
1
24
2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare lactate and total acid-base status in fetal scalp blood with lactate and total acid-base status in maternal blood and amniotic fluids to provide information on how lactate and base deficit correlates with scalp samples.

Furthermore, the investigators want to study whether angiogenic factors in fluids above may be a possible marker of asphyxia during labor.

Condition or Disease Intervention/Treatment Phase
  • Other: Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2014
Anticipated Study Completion Date :
Jan 1, 2014

Outcome Measures

Primary Outcome Measures

  1. Hypoxia [120 seconds]

    Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor

Secondary Outcome Measures

  1. Subacute hypoxia [120 seconds]

    Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All deliveries eligible for fetal blood sampling
Exclusion Criteria:
  • Non Swedish speaking

  • Those who decline to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Delivery department Uppsala University hospital Uppsala Sweden 75185

Sponsors and Collaborators

  • Uppsala University Hospital
  • Uppsala County Council, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Jonsson, Principal investigator, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01533701
Other Study ID Numbers:
  • UASKK2012
First Posted:
Feb 15, 2012
Last Update Posted:
Feb 15, 2012
Last Verified:
Feb 1, 2012
Keywords provided by Maria Jonsson, Principal investigator, Uppsala University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2012