Maternal Haemodynamic StabilityNICOM-USBNCT04026685
Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery
A study testing Phenylephrine infusion and Phenylephrine infusion and Ringer-Acetate bolus in people with Maternal Haemodynamic Stability, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Haemodynamic Stability
- What is being tested?
- Phenylephrine infusion and Phenylephrine infusion and Ringer-Acetate bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jan 2020to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology, University Hospital of Basel (USB)
Basel, 4031
About this study
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.
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.
- Conditions
- Maternal Haemodynamic Stability
- Being tested
- Phenylephrine infusion, Phenylephrine infusion and Ringer-Acetate bolus
- Keywords
- caesarean delivery, phenylephrine, spinal anaesthesia, vasopressor administration, pregnancy, non invasive cardiac output (CO) monitoring (NICOM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine infusionDrug
continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure
Phenylephrine infusion and Ringer-Acetate bolusDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine infusion only | Active comparator | Phenylephrine infusion only Receives: Drug: Phenylephrine infusion |
| Phenylephrine infusion and Ringer-Acetate bolus | Active comparator | Phenylephrine infusion and Ringer-Acetate bolus Receives: Drug: Phenylephrine infusion and Ringer-Acetate bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maternal cardiac output (CO)
CO measured by area under the curve (AUC) (L/min.)
Measured: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
Secondary outcomes (5)
Change in maternal heart rate
Change in maternal heart rate
Measured: 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)
Measured: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
incidence of maternal nausea
incidence of maternal Nausea (number)
Measured: 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).
Measured: at 1 and 5 minutes after delivery
Change in umbilical cord pH
Change in umbilical cord pH
Measured: at 1 and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start9 Jan 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Haemodynamic StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomised controlled non-inferiority trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bigna Buddeberg, Dr. med, Principal investigator, Department of Anaesthesiology, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026685
- Sponsor's protocol ID
- 2019-00866; qu18Buddeberg
- Other IDs
- 2019
- Acronym
- NICOM-USB
- Status last verified
- Feb 2021
- First submitted
- 17 Jul 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buddeberg BS, Seeberger E, Blasi C, Dutilh G, Steiner LA, Bandschapp O, Palanisamy A, Girard T. Is crystalloid co-loading necessary to prevent spinal hypotension during elective cesarean delivery? A randomized double-blind trial. Int J Obstet Anesth. 2024 May;58:103968. doi: 10.1016/j.ijoa.2023.103968. Epub 2023 Dec 13.
PubMed 38485584
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04026685
- Acronym / sponsor ID
- NICOM-USB / 2019-00866; qu18Buddeberg
- Conditions
- Maternal Haemodynamic Stability
- Keywords
- caesarean delivery, phenylephrine, spinal anaesthesia, vasopressor administration, pregnancy, non invasive cardiac output (CO) monitoring (NICOM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind, randomised controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine infusion only | Active comparator | Drug: Phenylephrine infusionPhenylephrine infusion only |
| Phenylephrine infusion and Ringer-Acetate bolus | Active comparator | Drug: Phenylephrine infusion and Ringer-Acetate bolusPhenylephrine infusion and Ringer-Acetate bolus |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to give informed consent
- Term uncomplicated singleton pregnancy
- Undergoing elective caesarean section under spinal anaesthesia
- Weight: 50-100kg
- Height: 150-180cm
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine infusioncontinuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure | Drug | Phenylephrine infusion only |
| Phenylephrine infusion and Ringer-Acetate boluscontinuous 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 | Drug | Phenylephrine infusion and Ringer-Acetate bolus |
Primary outcome
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.)
5 secondary outcomes
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
Time frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
incidence of maternal nausea
Time frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
Change in Apgar scores
Time frame: at 1 and 5 minutes after delivery
Change in umbilical cord pH
Time frame: at 1 and 5 minutes after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 38485584Buddeberg BS, Seeberger E, Blasi C, Dutilh G, Steiner LA, Bandschapp O, Palanisamy A, Girard T. Is crystalloid co-loading necessary to prevent spinal hypotension during elective cesarean delivery? A randomized double-blind trial. Int J Obstet Anesth. 2024 May;58:103968. doi: 10.1016/j.ijoa.2023.103968. Epub 2023 Dec 13.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bigna Buddeberg, Dr. med principal investigator
Department of Anaesthesiology, University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine infusion and Phenylephrine infusion and Ringer-Acetate bolus in people with Maternal Haemodynamic Stability, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maternal cardiac output (CO) (time frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.