Scalp Sampling for Fetal Surveillance (FBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Uppsala University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Maria Jonsson, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01533701
First received: February 6, 2012
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Hypoxia [ Time Frame: 120 seconds ] [ Designated as safety issue: No ]
    Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor


Secondary Outcome Measures:
  • Subacute hypoxia [ Time Frame: 120 seconds ] [ Designated as safety issue: No ]
    Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maria Jonsson, Principal investigator, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01533701     History of Changes
Other Study ID Numbers: UASKK2012
Study First Received: February 6, 2012
Last Updated: February 10, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics

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

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

ClinicalTrials.gov processed this record on July 24, 2014