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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hypotension

Intervention / Treatment
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* Procedure: Elective caesarean section under spinal anaesthesia.
* Procedure: Elective caesarean section under spinal anaesthesia.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent pneumatic compression<br>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. | Procedure: Elective caesarean section under spinal anaesthesia.<br>* Patients with scheduled caesarean.<br>|
| Active Comparator: Only pheniyephrine perfussion<br>No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia. | Procedure: Elective caesarean section under spinal anaesthesia.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of needed vasopressor (phenylephrine). |  | From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean, hypotension, Spinal Anaesthesia, intermittent pneumatic compression, lower extremities