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NCT Number: NCT04026685

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

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.

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Key information

Conditions

Maternal Haemodynamic Stability

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Phenylephrine infusion

Drug

continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure

Phenylephrine infusion and Ringer-Acetate bolus

Drug

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

Primary outcomes

  1. Change in maternal cardiac output (CO)

    Time frame: 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 outcomes

  1. 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 heart rate

  2. Change in maternal diastolic and systolic blood pressure

    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 (mmHg)

  3. incidence of maternal nausea

    Time frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping

    incidence of maternal Nausea (number)

  4. Change in Apgar scores

    Time frame: 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).

  5. Change in umbilical cord pH

    Time frame: at 1 and 5 minutes after delivery

    Change in umbilical cord pH

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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.

Acronym: NICOM-USB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2019
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.