NCT02237092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
21 days until next milestone

Results Posted

Study results publicly available

October 2, 2014

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

September 2, 2014

Results QC Date

September 10, 2014

Last Update Submit

January 2, 2019

Conditions

Obstetric Anesthesia ProblemsHigh-Risk Pregnancy

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (3)

  • Level of Sensory Blocks

    After spinal anesthesia, average 20 minutes.

  • The Level of IAP

    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.

Study Arms (1)

Measurement of IAP

EXPERIMENTAL

The data obtained are in inches of water column were translated in millimeters of mercury.

Procedure: Measurement of IAP

Interventions

Measurement of IAPPROCEDURE

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.

Measurement of IAP

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Gestational age \<= 35 weeks
  • Twins pregnancies
  • Disease the cardiovascular system (hypertension, etc.)
  • Non-elective caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tver Regional Perinatal Center

Tver', Russia

Location

Related Publications (3)

  • 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

    RESULT

Related Links

Results Point of Contact

Title
Dr. Alexandr Ronenson
Organization
Tver Regional Perinatal Center
ronensonam@gmail.com
011-7-4822-776213

Study Officials

  • Alexandr Ronenson, PhD student

    Tver Regional Perinatal Center

    PRINCIPAL INVESTIGATOR

  • Sergei Sitkin, DMedSc

    Tver State Medical Academy

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 11, 2014

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

January 15, 2019

Results First Posted

October 2, 2014

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)