High-Risk Pregnancy, Obstetric Anesthesia Problems
Conditions
Brief 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.
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.
Interventions
PROCEDUREMeasurement 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.
Sponsors
Tver Regional Perinatal Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Gestational age 36 - 40 weeks * Singleton pregnancies * Elective caesarean section
Exclusion criteria
* Gestational age \<= 35 weeks * Twins pregnancies * Disease the cardiovascular system (hypertension, etc.) * Non-elective caesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Level of Intra-abdominal Pressure (IAP) | 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) | 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 | Before spinal anesthesia, average 10 minutes. | Effect of obesity on the level of IAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Level of IAP | After spinal anesthesia, average 20 minutes. | The level of IAP in obstetric patients in the groups with high ( =\> Th4) and low (\< = Th5) blocks |
| Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg | After spinal anesthesia, average 20 minutes. | — |
| Level of Sensory Blocks | After spinal anesthesia, average 20 minutes. | 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 |
Countries
Russia
Participant flow
Recruitment details
Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section
Participants by arm
| Arm | Count |
|---|---|
| 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. | 196 |
| Total | 196 |
Baseline characteristics
| Characteristic | Measurement of IAP |
|---|---|
| Abdominal circumference | 105.1 cm STANDARD_DEVIATION 10.2 |
| Age, Continuous | 29.5 years STANDARD_DEVIATION 5.7 |
| Body mass index | 30.8 kg/m^2 STANDARD_DEVIATION 5.7 |
| Height | 163.9 cm STANDARD_DEVIATION 7.4 |
| Sex/Gender, Customized Female | 196 Pregnant women |
| Sex/Gender, Customized Male | 0 Pregnant women |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 134 |
| serious Total, serious adverse events | 23 / 62 | 17 / 134 |
Outcome results
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)
Time frame: Before spinal anesthesia, average 10 minutes.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intra-abdominal Pressure (IAP) in Pregnant Women | Classification Grade of Intra-abdominal Hypertension (IAH) | 11.60 mm Hg | Standard Error 0.09 |
| Grade I | Classification Grade of Intra-abdominal Hypertension (IAH) | 14.11 mm Hg | Standard Error 0.1 |
| Grade II | Classification Grade of Intra-abdominal Hypertension (IAH) | 17.43 mm Hg | Standard Error 0.14 |
| Grade III | Classification Grade of Intra-abdominal Hypertension (IAH) | 21.56 mm Hg | Standard Error 0.25 |
Primary
Obesity and IAP
Effect of obesity on the level of IAP
Time frame: Before spinal anesthesia, average 10 minutes.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intra-abdominal Pressure (IAP) in Pregnant Women | Obesity and IAP | 14.61 mm Hg | Standard Error 0.2 |
| Grade I | Obesity and IAP | 16.06 mm Hg | Standard Error 0.25 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: Before spinal anesthesia, average 10 minutes.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intra-abdominal Pressure (IAP) in Pregnant Women | The Level of Intra-abdominal Pressure (IAP) | 15.33 mm Hg | Standard Error 0.17 |
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
Time frame: After spinal anesthesia, average 20 minutes.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intra-abdominal Pressure (IAP) in Pregnant Women | Level of Sensory Blocks | 3.5 Block level level of thoracic vertebrae | Standard Error 0.1 |
| Grade I | Level of Sensory Blocks | 5.8 Block level level of thoracic vertebrae | Standard Error 0.1 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg
Time frame: After spinal anesthesia, average 20 minutes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intra-abdominal Pressure (IAP) in Pregnant Women | Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg | 29 Number of pregnants with Blocks = > Th4 |
| Grade I | Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg | 33 Number of pregnants with Blocks = > Th4 |
p-value: <0.0595% CI: [1.05, 2.58]NNT
Secondary
The Level of IAP
The level of IAP in obstetric patients in the groups with high ( =\> Th4) and low (\< = Th5) blocks
Time frame: After spinal anesthesia, average 20 minutes.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intra-abdominal Pressure (IAP) in Pregnant Women | The Level of IAP | 16.5 mm Hg | Standard Error 0.3 |
| Grade I | The Level of IAP | 14.0 mm Hg | Standard Error 0.2 |
p-value: <0.02t-test, 2 sided