NCT00991627

Different Approaches to Maternal Hypotension During Cesarean Section

Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Parma · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.

Detailed description

The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy. Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones. According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation. Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava. The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.

Conditions

• Pregnancy
• Cesarean Section
• Anesthesia,Spinal
• Hypotension

Interventions

Type	Name	Description
DRUG	Bupivacaine	10 mg of a 5 mg/ml hyperbaric solution, intrathecally
DRUG	Morphine	200 µg of a 100 µg/ml solution, intrathecally
DRUG	Lactated Ringer's solution	25 ml/min intravenously
DRUG	Ephedrine, continuous infusion	37.5 mg/h intravenously
DRUG	Ephedrine, bolus	6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm.
DRUG	Atropine	0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-10-08
• Last updated: 2010-08-27

Locations

1 site across 1 country: Italy