Trial Outcomes & Findings for Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia (NCT NCT02237092)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

196 participants

Primary outcome timeframe

Before spinal anesthesia, average 10 minutes.

Results posted on

2019-01-15

Participant Flow

Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	196
Overall Study COMPLETED	196
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Measurement of IAP n=196 Participants 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.
Age, Continuous	29.5 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex/Gender, Customized Female	196 Pregnant women n=5 Participants
Sex/Gender, Customized Male	0 Pregnant women n=5 Participants
Height	163.9 cm STANDARD_DEVIATION 7.4 • n=5 Participants
Body mass index	30.8 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants
Abdominal circumference	105.1 cm STANDARD_DEVIATION 10.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intra-abdominal Pressure (IAP) in Pregnant Women n=196 Participants Average IAP in pregnant women	Grade I (12 - 15.99 mm Hg)	Grade II (16 - 20.99 mm Hg)	Grade III (21 - 25.99 mm Hg)
The Level of Intra-abdominal Pressure (IAP)	15.33 mm Hg Standard Error 0.17	—	—	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Intra-abdominal Pressure (IAP) in Pregnant Women n=18 Participants Average IAP in pregnant women	Grade I n=96 Participants (12 - 15.99 mm Hg)	Grade II n=79 Participants (16 - 20.99 mm Hg)	Grade III n=3 Participants (21 - 25.99 mm Hg)
Classification Grade of Intra-abdominal Hypertension (IAH)	11.60 mm Hg Standard Error 0.09	14.11 mm Hg Standard Error 0.10	17.43 mm Hg Standard Error 0.14	21.56 mm Hg Standard Error 0.25

PRIMARY outcome

Timeframe: Before spinal anesthesia, average 10 minutes.

Effect of obesity on the level of IAP

Outcome measures

Outcome measures
Measure	Intra-abdominal Pressure (IAP) in Pregnant Women n=98 Participants Average IAP in pregnant women	Grade I n=98 Participants (12 - 15.99 mm Hg)	Grade II (16 - 20.99 mm Hg)	Grade III (21 - 25.99 mm Hg)
Obesity and IAP	14.61 mm Hg Standard Error 0.20	16.06 mm Hg Standard Error 0.25	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intra-abdominal Pressure (IAP) in Pregnant Women n=62 Participants Average IAP in pregnant women	Grade I n=134 Participants (12 - 15.99 mm Hg)	Grade II (16 - 20.99 mm Hg)	Grade III (21 - 25.99 mm Hg)
Level of Sensory Blocks	3.5 Block level level of thoracic vertebrae Standard Error 0.1	5.8 Block level level of thoracic vertebrae Standard Error 0.1	—	—

SECONDARY outcome

Timeframe: After spinal anesthesia, average 20 minutes.

The level of IAP in obstetric patients in the groups with high ( =\> Th4) and low (\< = Th5) blocks

Outcome measures

Outcome measures
Measure	Intra-abdominal Pressure (IAP) in Pregnant Women n=62 Participants Average IAP in pregnant women	Grade I n=134 Participants (12 - 15.99 mm Hg)	Grade II (16 - 20.99 mm Hg)	Grade III (21 - 25.99 mm Hg)
The Level of IAP	16.5 mm Hg Standard Error 0.3	14.0 mm Hg Standard Error 0.2	—	—

SECONDARY outcome

Timeframe: After spinal anesthesia, average 20 minutes.

Outcome measures

Outcome measures
Measure	Intra-abdominal Pressure (IAP) in Pregnant Women n=114 Participants Average IAP in pregnant women	Grade I n=82 Participants (12 - 15.99 mm Hg)	Grade II (16 - 20.99 mm Hg)	Grade III (21 - 25.99 mm Hg)
Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg	29 Number of pregnants with Blocks = > Th4	33 Number of pregnants with Blocks = > Th4	—	—

Adverse Events

Level of Sensory Block => Th4 (Spinal Anesthesia)

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Level of Sensory Block < = Th5 (Spinal Anesthesia)

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Level of Sensory Block => Th4 (Spinal Anesthesia) n=62 participants at risk Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure	Level of Sensory Block < = Th5 (Spinal Anesthesia) n=134 participants at risk Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
Cardiac disorders Hypotension	37.1% 23/62 • Number of events 23 • 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	12.7% 17/134 • Number of events 17 • 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

Other adverse events

Other adverse events
Measure	Level of Sensory Block => Th4 (Spinal Anesthesia) n=62 participants at risk Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure	Level of Sensory Block < = Th5 (Spinal Anesthesia) n=134 participants at risk Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
Pregnancy, puerperium and perinatal conditions Changing the type of anesthesia	0.00% 0/62 • 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	0.00% 0/134 • 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

Additional Information

Dr. Alexandr Ronenson

Tver Regional Perinatal Center

Phone: 011-7-4822-776213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place