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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01891175

Enrollment

120

Registered

2013-07-03

Start date

2013-05-31

Completion date

2014-09-30

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

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

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.

Interventions

PROCEDUREElective caesarean section under spinal anaesthesia.

Patients with scheduled caesarean.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026