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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.
There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=>Th4) sensor block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measurement of IAP | Experimental | The data obtained are in inches of water column were translated in millimeters of mercury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of IAP | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | Before spinal anesthesia, average 10 minutes. |
| Obesity and IAP | Effect of obesity on the level of IAP | Before spinal anesthesia, average 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After spinal anesthesia, average 20 minutes. |
| The Level of IAP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandr Ronenson, PhD student | Tver Regional Perinatal Center | Principal Investigator |
| Sergei Sitkin, DMedSc | Tver State Medical Academy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tver Regional Perinatal Center | Tver' | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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. | ||
| Result | 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 |
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Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section
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| ID | Title | Description |
|---|---|---|
| FG000 | Measurement of IAP | The data obtained are in inches of water column were translated in millimeters of mercury. 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, for 10 minutes, after quiet breathing pregnant at the time of expiration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pregnant planned for cesarean section
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| ID | Title | Description |
|---|---|---|
| BG000 | Measurement of 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, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Standard Error | mm Hg | Before spinal anesthesia, average 10 minutes. |
|
|
During the operation, an average of 30 minutes
Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Level of Sensory Block => Th4 (Spinal Anesthesia) | Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Hypotension | Systematic Assessment | Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Changing the type of anesthesia | Pregnancy, puerperium and perinatal conditions | General anesthesia | Systematic Assessment | Changing the type of anesthesia to General anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandr Ronenson | Tver Regional Perinatal Center | 011-7-4822-776213 | ronensonam@gmail.com |
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|
The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks |
| After spinal anesthesia, average 20 minutes. |
| Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg | After spinal anesthesia, average 20 minutes. |
| years |
|
| Sex/Gender, Customized | Number | Pregnant women |
|
| Height | Median | Standard Deviation | cm |
|
| Body mass index | Median | Standard Deviation | kg/m^2 |
|
| Abdominal circumference | Median | Standard Deviation | cm |
|
| Participants |
|
|
| Primary | 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) | Posted | Median | Standard Error | mm Hg | Before spinal anesthesia, average 10 minutes. |
|
|
|
| Secondary | 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 | Posted | Median | Standard Error | Block level level of thoracic vertebrae | After spinal anesthesia, average 20 minutes. |
|
|
|
|
| Primary | Obesity and IAP | Effect of obesity on the level of IAP | Posted | Median | Standard Error | mm Hg | Before spinal anesthesia, average 10 minutes. |
|
|
|
|
| Secondary | The Level of IAP | The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks | Posted | Median | Standard Error | mm Hg | After spinal anesthesia, average 20 minutes. |
|
|
|
|
| Secondary | Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg | Posted | Number | Number of pregnants with Blocks = > Th4 | After spinal anesthesia, average 20 minutes. |
|
|
|
|
| 23 |
| 62 |
| 0 |
| 62 |
| EG001 | Level of Sensory Block < = Th5 (Spinal Anesthesia) | Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure | 17 | 134 | 0 | 134 |
|
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