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

February 22, 2016 updated by: Lourdes Trillo, Parc de Salut Mar

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron Hospital
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Patients with scheduled caesarean.
Active Comparator: Only pheniyephrine perfussion
No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia.
Patients with scheduled caesarean.

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.
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).
Time Frame: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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