HypotensionNCT01095315
Delayed Positioning in Cesarean Section
A study testing lateral positioning in people with Hypotension, run by Seoul National University Hospital.
Trial summary
Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The possible explanation for this is combined aortocaval compression by gravid uterus in parturient in addition to reduced systemic vascular resistance by spinal anesthesia. Read more about this study
- Who is it for?
- Ages 28 to 44 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- lateral positioning
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2008
- 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 28 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton parturients undergoing elective cesarean section
- gestational age over 37 weeks
Who cannot join
- pregnancy with hypotension
- expecting fetal depression
About this study
Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The possible explanation for this is combined aortocaval compression by gravid uterus in parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The investigators evaluated if the incidence of hypotension would be decreased by delayed supine positioning, by maintaining lateral position for 6 min after spinal injection, in patients undergoing elective cesarean section.
- Conditions
- Hypotension
- Being tested
- lateral positioning
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral positioningOther
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
| Study group | Role | What they receive |
|---|---|---|
| standard | No intervention | parturients were placed back to the supine position immediately after spinal injection following standard protocol of spinal anesthesia |
| lateral | Experimental | the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position Receives: Other: lateral positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotension
hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes
Measured: after intrathecal injection until delivery (for 20 minutes)
Secondary outcomes (1)
sensory block level
highest sensory block level after intrathecal injection
Measured: during cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionSep 2008
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095315
- Sponsor's protocol ID
- delayed positioning
- Status last verified
- Mar 2010
- First submitted
- 22 Mar 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Positioning in Cesarean Section
- ClinicalTrials.gov ID
- NCT01095315
- Acronym / sponsor ID
- delayed positioning
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Mar 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.
Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The possible explanation for this is combined aortocaval compression by gravid uterus in parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The investigators evaluated if the incidence of hypotension would be decreased by delayed supine positioning, by maintaining lateral position for 6 min after spinal injection, in patients undergoing elective cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard | No intervention | –parturients were placed back to the supine position immediately after spinal injection following standard protocol of spinal anesthesia |
| lateral | Experimental | Other: lateral positioningthe lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position |
Who may qualify
- Ages
- 28 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- singleton parturients undergoing elective cesarean section
- gestational age over 37 weeks
Key exclusion criteria (2 listed)
- pregnancy with hypotension
- expecting fetal depression
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 |
|---|---|---|
| lateral positioningthe lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position | Other | lateral |
Primary outcome
hypotension
Time frame: after intrathecal injection until delivery (for 20 minutes)
hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes
1 secondary outcome
sensory block level
Time frame: during cesarean section
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 12 Apr 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?
A study testing lateral positioning in people with Hypotension, run by Seoul National University Hospital.
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 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: finished, as of the sponsor's last update on 12 Apr 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.
What does the primary outcome measure?
hypotension (time frame: after intrathecal injection until delivery (for 20 minutes)). 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 12 Apr 2010.