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

NCT01891175 | Completed

• 1 other identifier: CAESAREANFENI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypotension

Keywords

Caesarean; hypotension; Spinal Anaesthesia; intermittent pneumatic compression; lower extremities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).

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

Study Arms (2)

Intermittent pneumatic compression

EXPERIMENTAL

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.

Only pheniyephrine perfussion

ACTIVE COMPARATOR

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

Procedure: Elective caesarean section under spinal anaesthesia.

Interventions

Elective caesarean section under spinal anaesthesia. PROCEDURE

Patients with scheduled caesarean.

Intermittent pneumatic compression

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (3)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Vall d'Hebron Hospital

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 3, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

ES (3)