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Scalp Sampling for Fetal Surveillance (FBS)

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ClinicalTrials.gov Identifier: NCT01533701
Recruitment Status : Unknown
Verified February 2012 by Maria Jonsson, Uppsala University Hospital.
Recruitment status was:  Recruiting
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Hypoxia [ Time Frame: 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 [ Time Frame: 120 seconds ]
    Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533701


Contacts
Contact: Maria Jonsson, M.D +46186110000 maria.jonsson@kbh.uu.se
Contact: Lena Liljeström, M.D +46186110000 lena.liljestrom@kbh.uu.se

Locations
Sweden
Delivery department Uppsala University hospital Recruiting
Uppsala, Sweden, 75185
Contact: Maria Jonsson, M.D.    +46186110000    maria.jonsson@kbh.uu.se   
Contact: lena Liljeström, M.D.    +46186110000    lena.liljestrom@kbh.uu.se   
Principal Investigator: Lena Liljeström, M.D.         
Sponsors and Collaborators
Uppsala University Hospital
Uppsala County Council, Sweden
More Information

Responsible Party: Maria Jonsson, Principal investigator, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01533701     History of Changes
Other Study ID Numbers: UASKK2012
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Maria Jonsson, Uppsala University Hospital:
Hypoxia
Fetal blood sampling
Lactate
pH
base deficit
angiogenic factors
suspected fetal hypoxia

Additional relevant MeSH terms:
Hypoxia
Fetal Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Fetal Diseases
Pregnancy Complications