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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2021-02-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery

NCT06741410

Spinal Anesthesia Cesarean Delivery Neonatal Acidosis

COMPLETED

Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

NCT01378325

Anesthetic Complication Spinal

COMPLETED PHASE4

Norepinephrine in Caesarian Section

NCT05264870

Cesarean Section Complications Hemodynamic Instability Foetal Stress

TERMINATED PHASE4

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients

NCT00458003

Preeclampsia Hypotension

COMPLETED NA

Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

NCT03702400

Hypotension Spinal Anesthesia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maternal Haemodynamic Stability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind, randomised controlled non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Investigator and participant cannot see to which study group the participant belongs. The person performing randomisation and fluid application will not be involved in the data collection and Analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenylephrine infusion only

Group Type ACTIVE_COMPARATOR

Phenylephrine infusion

Intervention Type DRUG

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

Phenylephrine infusion and Ringer-Acetate bolus

Group Type ACTIVE_COMPARATOR

Phenylephrine infusion and Ringer-Acetate bolus

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phenylephrine infusion

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

Intervention Type DRUG

Phenylephrine infusion and Ringer-Acetate bolus

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No