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Scalp Sampling for Fetal Surveillance (FBS)

Primary Purpose

Fetal Hypoxia

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Hypoxia focused on measuring Hypoxia, Fetal blood sampling, Lactate, pH, base deficit, angiogenic factors, suspected fetal hypoxia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All deliveries eligible for fetal blood sampling

Exclusion Criteria:

  • Non Swedish speaking
  • Those who decline to participate in the study

Sites / Locations

  • Delivery department Uppsala University hospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2012
Last Updated
February 10, 2012
Sponsor
Uppsala University Hospital
Collaborators
Uppsala County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01533701
Brief Title
Scalp Sampling for Fetal Surveillance
Acronym
FBS
Official Title
Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
Collaborators
Uppsala County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Hypoxia
Keywords
Hypoxia, Fetal blood sampling, Lactate, pH, base deficit, angiogenic factors, suspected fetal hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling
Intervention Description
Fetal blood sampling is conducted when a non reassuring cardiotocographic pattern occurs to detect fetal hypoxia during labor. Amniotic fluid, maternal blood is sampled in cases of fetal blood sampling. Umbilical cord blood sampling is conducted at delivery.
Primary Outcome Measure Information:
Title
Hypoxia
Description
Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor
Time Frame
120 seconds
Secondary Outcome Measure Information:
Title
Subacute hypoxia
Description
Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor
Time Frame
120 seconds

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All deliveries eligible for fetal blood sampling Exclusion Criteria: Non Swedish speaking Those who decline to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Jonsson, M.D
Phone
+46186110000
Email
maria.jonsson@kbh.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Liljeström, M.D
Phone
+46186110000
Email
lena.liljestrom@kbh.uu.se
Facility Information:
Facility Name
Delivery department Uppsala University hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jonsson, M.D.
Phone
+46186110000
Email
maria.jonsson@kbh.uu.se
First Name & Middle Initial & Last Name & Degree
lena Liljeström, M.D.
Phone
+46186110000
Email
lena.liljestrom@kbh.uu.se
First Name & Middle Initial & Last Name & Degree
Lena Liljeström, M.D.

12. IPD Sharing Statement

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Scalp Sampling for Fetal Surveillance

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