HypotensionNCT01157520
Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device
An observational study of Hypotension, run by University Hospital Schleswig-Holstein.
Trial summary
Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2010
- 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 to 45 years
- Women only
- Adult
Study population: elective Cesarean section under spinal anesthesia
Who may be able to join
- ASA physical status I or II
- week of pregnancy >36
Who cannot join
- emergency cases
About this study
Official title: Hypotensive Episodes During Cesarean Section Detected by a Continuous Non-invasive Arterial Pressure Measurement Device Are Missed by the Oscillometric Blood Pressure Measurement
Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.
- Conditions
- Hypotension
- Medical subject headings
- Hypotension
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 |
|---|---|---|
| Cesarean | Women scheduled for elective Cesarean section under spinal anesthesia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157520
- Sponsor's protocol ID
- CNAP_Sectio
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 9 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotensive Episodes During Cesarean Section Detected by a Continuous Non-invasive Arterial Pressure Measurement Device Are Missed by the Oscillometric Blood Pressure Measurement
- ClinicalTrials.gov ID
- NCT01157520
- Acronym / sponsor ID
- CNAP_Sectio
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Jul 2010 (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.
Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean | – | –Women scheduled for elective Cesarean section under spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- elective Cesarean section under spinal anesthesia
Key inclusion criteria (2 listed)
- ASA physical status I or II
- week of pregnancy >36
Key exclusion criteria (1 listed)
- emergency cases
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 9 Jul 2010.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by University Hospital Schleswig-Holstein.
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 2 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 9 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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 9 Jul 2010; AzTrials last refreshed its copy on 1 Nov 2026.