Scalp Sampling for Fetal Surveillance

Fetal Hypoxia Clinical Trial

— FBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533701
• Other study ID #: UASKK2012
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2012
• Last updated: February 10, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2012
• Source: Uppsala University Hospital
• Contact: Maria Jonsson, M.D
• Phone: +46186110000
• Email: maria.jonsson[@]kbh.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• All deliveries eligible for fetal blood sampling

Exclusion Criteria:

• Non Swedish speaking

• Those who decline to participate in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fetal Hypoxia

Intervention

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.

Locations

Country	Name	City	State
Sweden	Delivery department Uppsala University hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxia	Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor	120 seconds	No
Secondary	Subacute hypoxia	Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor	120 seconds	No