Maternal Haemodynamic Stability
Conditions
Keywords
caesarean delivery, phenylephrine, spinal anaesthesia, vasopressor administration, pregnancy, non invasive cardiac output (CO) monitoring (NICOM)
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.
Interventions
continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure
DRUGPhenylephrine infusion and Ringer-Acetate bolus
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
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Investigator and participant cannot see to which study group the participant belongs. The person performing randomisation and fluid application will not be involved in the data collection and Analysis.
Intervention model description
double-blind, randomised controlled non-inferiority trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maternal cardiac output (CO) | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | CO measured by area under the curve (AUC) (L/min.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maternal heart rate | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | Change in maternal heart rate |
| Change in maternal diastolic and systolic blood pressure | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | Change in maternal diastolic and systolic blood pressure (mmHg) |
| incidence of maternal nausea | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping | incidence of maternal Nausea (number) |
| Change in Apgar scores | at 1 and 5 minutes after delivery | 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). |
| Change in umbilical cord pH | at 1 and 5 minutes after delivery | Change in umbilical cord pH |
Countries
Switzerland
Outcome results
None listed