QuestionnaireNCT01277588
Evaluation of the Physicians and Patients Experience of Fetal Scalp Sampling
An observational study of Questionnaire and Fetal Scalp Sampling, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test is performed with the woman in the supine position and is generally described as a difficult and cumbersome procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Questionnaire, Fetal Scalp Sampling
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to Aug 2011
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are subjected to fetal scalp sampling during labor Physicians performning fetal scalp sampling
Who may be able to join
- fetal scalp sampling during labor
Who cannot join
- non-proficiency in the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test is performed with the woman in the supine position and is generally described as a difficult and cumbersome procedure.
Read the detailed description
Women who were subjected to fetal scalp sampling are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the woman experienced the testing procedure.
Physicans who performed the test are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the physician experienced the testing procedure.
- Conditions
- Questionnaire, Fetal Scalp Sampling
- Keywords
- fetal scalp sampling, experience questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Not described | |
| Physcician | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuestionnaireStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Jonsson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277588
- Sponsor's protocol ID
- UAS2010/003
- Status last verified
- Jan 2012
- First submitted
- 14 Jan 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Physicians and Patients Experience of Fetal Scalp Sampling
- ClinicalTrials.gov ID
- NCT01277588
- Acronym / sponsor ID
- UAS2010/003
- Conditions
- Questionnaire, Fetal Scalp Sampling
- Keywords
- fetal scalp sampling, experience questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Jan 2011 (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.
During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test is performed with the woman in the supine position and is generally described as a difficult and cumbersome procedure.
Detailed description
Women who were subjected to fetal scalp sampling are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the woman experienced the testing procedure.
Physicans who performed the test are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the physician experienced the testing procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | – |
| Physcician | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are subjected to fetal scalp sampling during labor Physicians performning fetal scalp sampling
Key inclusion criteria (1 listed)
- fetal scalp sampling during labor
Key exclusion criteria (1 listed)
- non-proficiency in the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Questionnaire and Fetal Scalp Sampling, 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 1 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: finished, as of the sponsor's last update on 18 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Jan 2012.