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

Parc de Salut Mar

Status: Completed

Conditions: Hypotension

Treatments: Procedure: Elective caesarean section under spinal anaesthesia.

Study type: Interventional

Funder types: Other

Identifiers

NCT01891175

CAESAREANFENI

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intermittent pneumatic compression

Experimental group

Description:

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.

Treatment:

Procedure: Elective caesarean section under spinal anaesthesia.

Procedure: Elective caesarean section under spinal anaesthesia.

Only pheniyephrine perfussion

Active Comparator group

Description:

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

Treatment:

Procedure: Elective caesarean section under spinal anaesthesia.

Procedure: Elective caesarean section under spinal anaesthesia.