Obstetrics for C/SNCT00748176
The Relationship of Abdominal Circumference and Trunk Length With the Level of Spinal Anesthesia in Obstetric Patients
An observational study of Obstetrics for C/S, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The body shape might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetrics for C/S
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Oct 2009
- 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
- No healthy volunteers
- Adult
Study population: Obstetric patients for C/S
Who may be able to join
- Obstetric patients for C/S
Who cannot join
- With major systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The body shape might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section.
Read the detailed description
The level of spinal anesthesia in obstetric patients had been investigated in several studies. Increased cephalad spread of local anesthetics had been demonstrated with increased intra-abdominal pressure, changes in anteroposterior spinal curves and lumbar lordosis. Theoretically the body shape might have contribution to the above factors and might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section. Only those C/S patients indicated and scheduled for spinal anesthesia will be observed. The spinal anesthesia will be performed as routine practice. This study will not change the clinical plan in any aspect. We will only passively record the abdominal circumference, trunk length and the level of spinal anesthesia and calculate the correlation between them.
- Conditions
- Obstetrics for C/S
- Being tested
- spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
spinal anesthesia with bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Procedure: spinal anesthesia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetrics for C/SStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hui-Hsun Huang, Principal investigator, Department of anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748176
- Sponsor's protocol ID
- 200805027R
- Status last verified
- Dec 2009
- First submitted
- 1 Sep 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Abdominal Circumference and Trunk Length With the Level of Spinal Anesthesia in Obstetric Patients
- ClinicalTrials.gov ID
- NCT00748176
- Acronym / sponsor ID
- 200805027R
- Conditions
- Obstetrics for C/S
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Sep 2008 (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 body shape might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section.
Detailed description
The level of spinal anesthesia in obstetric patients had been investigated in several studies. Increased cephalad spread of local anesthetics had been demonstrated with increased intra-abdominal pressure, changes in anteroposterior spinal curves and lumbar lordosis. Theoretically the body shape might have contribution to the above factors and might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section. Only those C/S patients indicated and scheduled for spinal anesthesia will be observed. The spinal anesthesia will be performed as routine practice. This study will not change the clinical plan in any aspect. We will only passively record the abdominal circumference, trunk length and the level of spinal anesthesia and calculate the correlation between them.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obstetric patients for C/S
Key inclusion criteria (1 listed)
- Obstetric patients for C/S
Key exclusion criteria (1 listed)
- With major systemic diseases
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 |
|---|---|---|
| spinal anesthesiaspinal anesthesia with bupivacaine | Procedure or surgery | A |
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 15 Dec 2009.
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.
Hui-Hsun Huang principal investigator
Department of anesthesiology, National Taiwan University Hospital
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 Obstetrics for C/S, run by National Taiwan University Hospital at 1 site in Taiwan.
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 15 Dec 2009. 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 Taiwan. 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 15 Dec 2009.