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

Not Applicable

Completed

• Conditions: Hypotension
• Interventions: Procedure: Elective caesarean section under spinal anaesthesia.

• Registration Number: NCT01891175
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-03
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent pneumatic compression	Elective caesarean section under spinal anaesthesia.	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.
Only pheniyephrine perfussion	Elective caesarean section under spinal anaesthesia.	No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).	Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.

Trial Locations

Locations (3)

Hospital Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain