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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lourdes Trillo, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01891175
First received: May 24, 2013
Last updated: February 22, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention
Hypotension
Procedure: Elective caesarean section under spinal anaesthesia.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]
    Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.


Enrollment: 120
Study Start Date: May 2013
Study Completion Date: September 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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.
Procedure: Elective caesarean section under spinal anaesthesia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891175

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital Vall d'Hebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Parc de Salut Mar
  More Information

Responsible Party: Lourdes Trillo, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01891175     History of Changes
Other Study ID Numbers: CAESAREANFENI 
Study First Received: May 24, 2013
Last Updated: February 22, 2016
Health Authority: Spain: Ethics Committee

Keywords provided by Parc de Salut Mar:
Caesarean
hypotension
Spinal Anaesthesia
intermittent pneumatic compression
lower extremities

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016