CompletedNot Applicable

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

Switzerland66 participantsStarted 2020-01-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in maternal cardiac output (CO)

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

Trial details

NCT IDNCT04026685

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-05

View on ClinicalTrials.gov More Maternal Haemodynamic Stability trials