Obstetric Anesthesia ProblemsIAPSBNCT02237092
Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
A study testing Measurement of IAP in people with Obstetric Anesthesia Problems and High-Risk Pregnancy, run by Tver Regional Perinatal Center at 1 site in Russia.
Trial summary
It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anesthesia Problems, High-Risk Pregnancy
- What is being tested?
- Measurement of IAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age 36 - 40 weeks
- Singleton pregnancies
- Elective caesarean section
Who cannot join
- Gestational age <= 35 weeks
- Twins pregnancies
- Disease the cardiovascular system (hypertension, etc.)
- Non-elective caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block.
Read the detailed description
There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=>Th4) sensor block.
- Conditions
- Obstetric Anesthesia Problems, High-Risk Pregnancy
- Being tested
- Measurement of IAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of IAPProcedure or surgery
The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of IAP | Experimental | The data obtained are in inches of water column were translated in millimeters of mercury. Receives: Procedure: Measurement of IAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Level of Intra-abdominal Pressure (IAP)
Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.
Measured: Before spinal anesthesia, average 10 minutes.
Classification Grade of Intra-abdominal Hypertension (IAH)
Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)
Measured: Before spinal anesthesia, average 10 minutes.
Obesity and IAP
Effect of obesity on the level of IAP
Measured: Before spinal anesthesia, average 10 minutes.
Secondary outcomes (3)
Level of Sensory Blocks
Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra
Measured: After spinal anesthesia, average 20 minutes.
The Level of IAP
The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks
Measured: After spinal anesthesia, average 20 minutes.
Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg
Measured: After spinal anesthesia, average 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anesthesia ProblemsStudies 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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tver Regional Perinatal Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandr Ronenson, PhD student, Principal investigator, Tver Regional Perinatal CenterSergei Sitkin, DMedSc, Study director, Tver State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237092
- Sponsor's protocol ID
- TR-1
- Acronym
- IAPSB
- Status last verified
- Jan 2019
- First submitted
- 2 Sep 2014
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
S. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.
Sitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.
Sitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02237092
- Acronym / sponsor ID
- IAPSB / TR-1
- Conditions
- Obstetric Anesthesia Problems, High-Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Tver Regional Perinatal CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 2 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block.
Detailed description
There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=>Th4) sensor block.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of IAP | Experimental | Procedure: Measurement of IAPThe data obtained are in inches of water column were translated in millimeters of mercury. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age 36 - 40 weeks
- Singleton pregnancies
- Elective caesarean section
Key exclusion criteria (4 listed)
- Gestational age <= 35 weeks
- Twins pregnancies
- Disease the cardiovascular system (hypertension, etc.)
- Non-elective caesarean section
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 |
|---|---|---|
| Measurement of IAPThe level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration. | Procedure or surgery | Measurement of IAP |
Primary outcome
The Level of Intra-abdominal Pressure (IAP)
Time frame: Before spinal anesthesia, average 10 minutes.
Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.
Classification Grade of Intra-abdominal Hypertension (IAH)
Time frame: Before spinal anesthesia, average 10 minutes.
Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)
Obesity and IAP
Time frame: Before spinal anesthesia, average 10 minutes.
Effect of obesity on the level of IAP
3 secondary outcomes
Level of Sensory Blocks
Time frame: After spinal anesthesia, average 20 minutes.
The Level of IAP
Time frame: After spinal anesthesia, average 20 minutes.
Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg
Time frame: After spinal anesthesia, average 20 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationS. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.
- Results publicationSitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.
- Results publicationSitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179
- Individual participant dataSharing planned: No
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Obstetric, Cesarean Birth
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.
Alexandr Ronenson, PhD student principal investigator
Tver Regional Perinatal Center
Sergei Sitkin, DMedSc study director
Tver State Medical Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of IAP in people with Obstetric Anesthesia Problems and High-Risk Pregnancy, run by Tver Regional Perinatal Center at 1 site in Russia.
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 3 inclusion and 4 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 Jan 2019. 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 Russia. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Level of Intra-abdominal Pressure (IAP) (time frame: Before spinal anesthesia, average 10 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237092, which also lists 3 linked publications.
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 Jan 2019.