- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891175
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona, Spain, 08003
- Hospital del Mar
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Barcelona, Spain, 08035
- Hospital Vall d'Hebron Hospital
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Germans Trias i Pujol
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intermittent pneumatic compression
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.
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Patients with scheduled caesarean.
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Active Comparator: Only pheniyephrine perfussion
No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia.
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Patients with scheduled caesarean.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).
Time Frame: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).
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Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.
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From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAESAREANFENI
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