Scalp Sampling for Fetal Surveillance | NCT01533701

Studies
Scalp Sampling for Fetal Surveillance

NCT01533701

Sponsor

Uppsala University Hospital

Status

Unknown status

Last Update Posted

Feb 15, 2012Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Fetal Hypoxia

Interventions

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

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Feb 6, 2012

First Submission Date that Met QC Criteria

Feb 10, 2012

First Posted Date

Feb 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2012

Last Update Posted Date

Feb 15, 2012Estimated

Name	Class
Uppsala County Council, Sweden	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All deliveries eligible for fetal blood sampling

Exclusion Criteria:

Non Swedish speaking
Those who decline to participate in the study

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Jonsson, M.D	Contact	+46186110000		maria.jonsson@kbh.uu.se
Lena Liljeström, M.D	Contact	+46186110000		lena.liljestrom@kbh.uu.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Delivery department Uppsala University hospital	Recruiting	Uppsala		75185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D005311	Fetal Hypoxia
D000860	Hypoxia

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided