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 |
---|---|---|
|
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
- Hypoxia [120 seconds]
Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor
Secondary Outcome Measures
- 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: