Scalp Sampling for Fetal Surveillance (FBS)

February 10, 2012 updated by: Maria Jonsson, Uppsala University Hospital

Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor

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.

Study Overview

Status

Unknown

Conditions

Fetal Hypoxia

Intervention / Treatment

Other: Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Sweden
- - Uppsala, Sweden, 75185
    - Recruiting
    - Delivery department Uppsala University hospital
    - Contact:
      
      Maria Jonsson, M.D.
      
      Phone Number: +46186110000
      
      Email: maria.jonsson@kbh.uu.se
    - Contact:
      
      lena Liljeström, M.D.
      
      Phone Number: +46186110000
      
      Email: lena.liljestrom@kbh.uu.se
    - Principal Investigator:
      
      Lena Liljeström, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All deliveries eligible for fetal blood sampling

Exclusion Criteria:

Non Swedish speaking
Those who decline to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxia Time Frame: 120 seconds	Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor	120 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subacute hypoxia Time Frame: 120 seconds	Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor	120 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Uppsala County Council, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)