Clinical trial NCT04026685: Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Haemodynamic Stability
Keywords: caesarean delivery
phenylephrine
spinal anaesthesia
vasopressor administration
pregnancy
non invasive cardiac output (CO) monitoring (NICOM)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, randomised controlled non-inferiority trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in maternal cardiac output (CO)
timeFrame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
Secondary outcomes:
measure: Change in maternal heart rate
timeFrame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
measure: Change in maternal diastolic and systolic blood pressure
timeFrame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
measure: incidence of maternal nausea
timeFrame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
measure: Change in Apgar scores
timeFrame: at 1 and 5 minutes after delivery
measure: Change in umbilical cord pH
timeFrame: at 1 and 5 minutes after delivery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anaesthesiology, University Hospital of Basel (USB)
Study officials:
affiliation: Department of Anaesthesiology, University Hospital of Basel
name: Bigna Buddeberg, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: