Scalp Sampling for Fetal Surveillance (FBS)

This study is currently recruiting participants.

Verified February 2012 by Uppsala University Hospital

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

History of Changes

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:

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

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 May 23, 2013

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