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The effect of goal directed fluid, inotrope and vasopressor therapy in preeclamptic patients undergoing caesarean section delivery under spinal anaest - Trial PACTR201604001597634

Access comprehensive clinical trial information for PACTR201604001597634 through Pure Global AI's free database. This Not Applicable trial is sponsored by Department of Anaesthesiology and is currently Not yet recruiting. The study focuses on Pregnancy and Childbirth; Surgery; Other.

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PACTR201604001597634
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Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR201604001597634
Pure Global
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The effect of goal directed fluid, inotrope and vasopressor therapy in preeclamptic patients undergoing caesarean section delivery under spinal anaest
The effect of goal directed fluid, inotrope and vasopressor therapy in preeclamptic patients undergoing caesarean section delivery under spinal anaesthesia with the use of a non-invasive finger cuff cardiac output monitor

Study Focus

device

Sponsor & Location

Department of Anaesthesiology

South Africa

Timeline & Enrollment

Not Applicable

Jan 01, 1900

Jan 01, 1900

Summary

The haemodynamic response to spinal anaesthesia in patients with preeclampsia is poorly understood and often characterised by significant haemodynamic fluctuations which may compromise utero-placental blood flow and so neonatal outcomes. Blood pressure is routinely used as a surrogate marker of cardiac output. Numerous studies have demonstrated a poor correlation between blood pressure and utero-placental blood flow in preeclamptic patients. Furthermore, several studies indicate that the changes in cardiac output induced by spinal anaesthesia are more closely matched to changes in utero-placental blood flow. It may therefore be advantageous to measure cardiac output directly.The availability of new, non-invasive technologies, such as the ClearSight (Edwards LifeSciences, Irvine, California, United States of America), is likely to make perioperative monitoring of cardiac output more accessible, readily applicable and a viable option for the intraoperative management of all preeclamptic patients presenting for caesarean section delivery. The ClearSight has been validated in a number of clinical settings and is approved by the manufacturer for use in obstetric patients. Currently, however, there is a paucity of literature regarding their role in the management of patients undergoing caesarean section delivery. The primary outcome of the study is to document the effect of goal directed therapy using a non-invasive finger cuff cardiac output monitor on umbilical cord lactate in patients with preeclampsia, undergoing caesarean section delivery under spinal anaesthesia. Secondary outcomes include the change in umbilical cord pH, base excess, cortisol levels and neonatal APGAR scores as well as the change in maternal haemodynamic variables including cardiac output, cardiac index, systemic vascular resistance, systemic vascular resistance index and stroke volume variation.

ICD-10 Classifications

Other complications of obstetric surgery and procedures
Pregnancy, childbirth and the puerperium
Fetus and newborn affected by surgical procedure on mother
Other specified complications of labour and delivery
Personal history of complications of pregnancy, childbirth and the puerperium

Data Source

Pan Africa Clinical Trials Registry

PACTR201604001597634

Device Trial