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Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Elective caesarean section under spinal anaesthesia.
Elective caesarean section under spinal anaesthesia.
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Caesarean, hypotension, Spinal Anaesthesia, intermittent pneumatic compression, lower extremities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.

Exclusion Criteria:

  • Caesarean section urgent / emergent
  • Caesarean section with epidural anaesthesia
  • Caesarean section of multiple pregnancies
  • Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (<32 weeks)
  • Valvular heart disease and / or ischemic
  • High blood pressure diagnosed and in treatment.
  • Sepsis
  • Morbid obesity (BMI> 40)
  • Insulin-dependent diabetes
  • Block level achieved with spinal anaesthesia> T5
  • Patients that can not meet the study protocol

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital del Mar
  • Hospital Vall d'Hebron Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent pneumatic compression

Only pheniyephrine perfussion

Arm Description

With intermittent pneumatic compression of the lower extremities (Covidien / Kendall SCD ™ sequential compression systems) plus phenylephrine perfusion (usual treatment)in elective caesarean section under spinal anaesthesia.

No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia.

Outcomes

Primary Outcome Measures

The dose of needed vasopressor (phenylephrine).

Secondary Outcome Measures

Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).
Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.

Full Information

First Posted
May 24, 2013
Last Updated
February 22, 2016
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT01891175
Brief Title
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities
Official Title
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby. The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Caesarean, hypotension, Spinal Anaesthesia, intermittent pneumatic compression, lower extremities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent pneumatic compression
Arm Type
Experimental
Arm Description
With intermittent pneumatic compression of the lower extremities (Covidien / Kendall SCD ™ sequential compression systems) plus phenylephrine perfusion (usual treatment)in elective caesarean section under spinal anaesthesia.
Arm Title
Only pheniyephrine perfussion
Arm Type
Active Comparator
Arm Description
No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
Elective caesarean section under spinal anaesthesia.
Intervention Description
Patients with scheduled caesarean.
Intervention Type
Procedure
Intervention Name(s)
Elective caesarean section under spinal anaesthesia.
Primary Outcome Measure Information:
Title
The dose of needed vasopressor (phenylephrine).
Time Frame
From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.
Secondary Outcome Measure Information:
Title
Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).
Description
Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.
Time Frame
From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed. Exclusion Criteria: Caesarean section urgent / emergent Caesarean section with epidural anaesthesia Caesarean section of multiple pregnancies Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (<32 weeks) Valvular heart disease and / or ischemic High blood pressure diagnosed and in treatment. Sepsis Morbid obesity (BMI> 40) Insulin-dependent diabetes Block level achieved with spinal anaesthesia> T5 Patients that can not meet the study protocol
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d'Hebron Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

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Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities

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