NCT01533701

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

February 6, 2012

Last Update Submit

February 10, 2012

Conditions

Fetal Hypoxia

Keywords

HypoxiaFetal blood samplingLactatepHbase deficitangiogenic factorssuspected fetal hypoxia

Outcome Measures

Primary Outcomes (1)

  • Hypoxia

    Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor

    120 seconds

Secondary Outcomes (1)

  • Subacute hypoxia

    120 seconds

Interventions

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

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 Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All deliveries eligible for fetal blood sampling

You may not qualify if:

  • Non Swedish speaking
  • Those who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delivery department Uppsala University hospital

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Fetal HypoxiaHypoxia

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Jonsson, M.D

CONTACT

+46186110000maria.jonsson@kbh.uu.se

Lena Liljeström, M.D

CONTACT

+46186110000lena.liljestrom@kbh.uu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 15, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

SE(1)