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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-09-30

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.

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Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Elective caesarean section under spinal anaesthesia.

Intervention Type PROCEDURE

Patients with scheduled caesarean.

Only pheniyephrine perfussion

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

Group Type ACTIVE_COMPARATOR

Elective caesarean section under spinal anaesthesia.

Intervention Type PROCEDURE

Interventions

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Elective caesarean section under spinal anaesthesia.

Patients with scheduled caesarean.

Intervention Type PROCEDURE

Elective caesarean section under spinal anaesthesia.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes