An interventional study of Phenylephrine infusion and Phenylephrine infusion and Ringer-Acetate bolus in Maternal Haemodynamic Stability, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
Phenylephrine infusion only
Drug: Phenylephrine infusion
Phenylephrine infusion and Ringer-Acetate bolus
Drug: Phenylephrine infusion and Ringer-Acetate bolus
continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure
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
Change in maternal cardiac output (CO)
CO measured by area under the curve (AUC) (L/min.)
Time frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
Change in maternal heart rate
Change in maternal heart rate
Time frame: 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)
Time frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
incidence of maternal nausea
incidence of maternal Nausea (number)
Time frame: 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).
Time frame: at 1 and 5 minutes after delivery
Change in umbilical cord pH
Change in umbilical cord pH
Time frame: at 1 and 5 minutes after delivery
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland