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

Not Applicable

Completed

• Conditions: Maternal Haemodynamic Stability
• Interventions: Drug: Phenylephrine infusion; Drug: Phenylephrine infusion and Ringer-Acetate bolus

• Registration Number: NCT04026685
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2020-01-09
• Status Verified: 2021-02
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-05
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine infusion only	Phenylephrine infusion	Phenylephrine infusion only
Phenylephrine infusion and Ringer-Acetate bolus	Phenylephrine infusion and Ringer-Acetate bolus	Phenylephrine infusion and Ringer-Acetate bolus

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 umbilical cord pH	at 1 and 5 minutes after delivery	Change in umbilical cord pH
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 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).

Trial Locations

Locations (1)

Department of Anaesthesiology, University Hospital of Basel (USB); 🇨🇭 Basel, Switzerland