Fetal HypoxiaFBSNCT01533701
Scalp Sampling for Fetal Surveillance
A study testing Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling in people with Fetal Hypoxia, run by Uppsala University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Hypoxia
- What is being tested?
- Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All deliveries eligible for fetal blood sampling
Who cannot join
- Non Swedish speaking
- Those who decline to participate in the study
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Delivery department Uppsala University hospital
Uppsala, 75185
Maria Jonsson, M.D., +46186110000, maria.jonsson@kbh.uu.se
lena Liljeström, M.D., +46186110000, lena.liljestrom@kbh.uu.se
About this study
Official title: Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor
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.
- Conditions
- Fetal Hypoxia
- Being tested
- Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling
- Keywords
- Hypoxia, Fetal blood sampling, Lactate, pH, base deficit, angiogenic factors, suspected fetal hypoxia
- Medical subject headings
- Fetal Hypoxia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia
Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor
Measured: 120 seconds
Secondary outcomes (1)
Subacute hypoxia
Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor
Measured: 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Maria Jonsson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533701
- Sponsor's protocol ID
- UASKK2012
- Acronym
- FBS
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor
- ClinicalTrials.gov ID
- NCT01533701
- Acronym / sponsor ID
- FBS / UASKK2012
- Conditions
- Fetal Hypoxia
- Keywords
- Hypoxia, Fetal blood sampling, Lactate, pH, base deficit, angiogenic factors, suspected fetal hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All deliveries eligible for fetal blood sampling
Key exclusion criteria (2 listed)
- Non Swedish speaking
- Those who decline to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord samplingFetal 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. | Other | – |
Primary outcome
Hypoxia
Time frame: 120 seconds
Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor
1 secondary outcome
Subacute hypoxia
Time frame: 120 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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Evaluation of the Fetal Response to Intrapartum Digital Fetal Scalp Stimulation to Identify Intrapartum Fetal Hypoxia.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling in people with Fetal Hypoxia, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Jonsson, M.D (+46186110000, maria.jonsson@kbh.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia (time frame: 120 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2012; AzTrials last refreshed its copy on 28 Oct 2026.