Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery

Study Overview
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Brief Summary
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Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.

Official Title
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Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery: a Double-blind, Randomised Controlled Trial Using the Non Invasive Cardiac Output Monitor StarlingTM SV.

Conditions
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Maternal Haemodynamic Stability

Intervention / Treatment
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* Drug: Phenylephrine infusion
* Drug: Phenylephrine infusion and Ringer-Acetate bolus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give informed consent Term uncomplicated singleton pregnancy Undergoing elective caesarean section under spinal anaesthesia Weight: 50-100kg Height: 150-180cm Healthy term fetus Exclusion Criteria: Inability to give informed consent Multiple pregnancy Clinically significant concomitant disease states (e.g. hypertension, cardiac disease, severe asthma requiring regular medication, comorbidities affecting the autonomous nervous system, renal disease) On any cardiovascular medication Complications of pregnancy (e.g. preeclampsia, intrauterine growth restriction, fetal malformations) Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant, Participation in another study with investigational drug within the 30 days preceding and during the present study, Previous enrolment into the current study, Enrolment of the investigator, his/her family members, employees and other dependent persons Any fetal pathology (e.g. fetal malformations, rupture of membranes before caesarean section, oligohydramnios, polyhydramnios, suspected chorioamnionitis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind, randomised controlled non-inferiority trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenylephrine infusion only<br>Phenylephrine infusion only | Drug: Phenylephrine infusion<br>* continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure<br>|
| Active Comparator: Phenylephrine infusion and Ringer-Acetate bolus<br>Phenylephrine infusion and Ringer-Acetate bolus | Drug: Phenylephrine infusion and Ringer-Acetate bolus<br>* continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure plus crystalloid Ringer-Acetate co-loading bolus of 1000 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maternal cardiac output (CO) | CO measured by area under the curve (AUC) (L/min.) | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maternal heart rate | Change in maternal heart rate | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | 
| Change in maternal diastolic and systolic blood pressure | Change in maternal diastolic and systolic blood pressure (mmHg) | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | 
| incidence of maternal nausea | incidence of maternal Nausea (number) | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | 
| Change in Apgar scores | The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration). | at 1 and 5 minutes after delivery | 
| Change in umbilical cord pH | Change in umbilical cord pH | at 1 and 5 minutes after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean delivery, phenylephrine, spinal anaesthesia, vasopressor administration, pregnancy, non invasive cardiac output (CO) monitoring (NICOM)