CesareanEDLIDLNCT05133271
Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.
A study testing Clinical hemodynamic and echocardiographic evaluation in people with Cesarean and Spinal Anesthesia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean, Spinal Anesthesia
- What is being tested?
- Clinical hemodynamic and echocardiographic evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2021to 3 Aug 2024
- 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
- Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
- Written informed consent
Who cannot join
- No health insurance
- Urgent cesarean
- Failure of spinal anesthesia
- Free and informed consent impossible to obtain (especially due to a language barrier)
- Severe cardiovascular or neurovascular comorbidities
- Contraindication to the PLR (intracranial hypertension, fractures of the pelvis and / or lower limbs, ...)
- Background of preeclampsia or eclampsia
- Severe fetal pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Read the detailed description
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia.
Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Patients will have a clinical hemodynamic and echocardiographic evaluation, before performing the spinal anesthesia, before and after the passive leg raise test.
Then, the patients will benefit from a clinical hemodynamic evaluation during the preparation of the parturient in the operating room and finally after the completion of the spinal anesthesia and until the clamping of the umbilical cord.
- Conditions
- Cesarean, Spinal Anesthesia
- Being tested
- Clinical hemodynamic and echocardiographic evaluation
- Keywords
- Passive leg raise test (PLR), Cesarean section, Spinal anesthesia, Maternal arterial hypotension, Phenylephrine requirements, Norepinephrine requirements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical hemodynamic and echocardiographic evaluationOther
Clinical hemodynamic and echocardiographic evaluation in two stages T1 and T2, before performing the spinal anesthesia, carried out by a doctor different from the doctor in charge of the parturient in the operating room to ensure the blind hemodynamic results before the spinal anesthesia, in particular those of the passive leg raise test (PLR) :
- T1: clinico-echographic evaluation in dorsal decubitus position (45 °) with cushion under the right buttock.
- T2: clinico-ultrasound evaluation after performing the PLR. Then, clinical hemodynamic evaluation during two periods T3 and T4:
- T3: conditioning time of the parturient in the operating room during which clinical hemodynamic monitoring is set up and the basic values of arterial pressures (systolic, diastolic and mean) and heart rate are defined.
- T4: period after performing spinal anesthesia until clamping of the umbilical cord.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled cesarean section | Experimental | Patient with scheduled cesarean section under spinal anesthesia. Receives: Other: Clinical hemodynamic and echocardiographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal arterial hypotension
Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)> 20% of baseline.
Measured: Day 0
Positivity of passive leg raise test
A positive passive leg raise test is defined as an increase in the Subaortic Flow Velocity Time Integral of 10% or more. The increase in cardiac output is measured by a cardiac ultrasound.
Measured: Day 0
Positive passive leg raise test performance
Performance of a positive passive leg raise test in predicting the onset of maternal arterial hypotension after spinal anesthesia. Significant performance will be defined by sensitivity and specificity > 90%.
Measured: Day 0
Secondary outcomes (13)
Total dose of norepinephrine
Total dose of norepinephrine received during the procedure from the beginning of the spinal anesthesia injection up to umbilical cord clamping measured in micrograms.
Measured: Day 0
Onset of severe arterial hypotension
Onset of severe arterial hypotension defined as a drop in systolic blood pressure greater than 30% of baseline.
Measured: Day 0
Onset of nausea and vomiting
Onset of nausea and vomiting from the spinal anesthesia injection up to the end of the c-section.
Measured: Day 0
Occurrence of disturbances of consciousness
Occurrence of consciousness alteration assessed by the Glasgow Coma Scale (from Teasdale G \& Jennett B. Lancet 1974).
Three aspects of behavior are measured independently: motor response, verbal response and eye opening.
Each component has a number of grades starting with the most severe. The best ocular response has 4 grades; the best verbal response has 5 grades; the best motor response has 6 grades.
Rating: the score of each component as well as the sum of the components are considered. The total score is out of 15 points; lower scores indicating more severe impairment. The lowest possible score is 3, indicating deep coma or death, and the highest possible score is 15, indicating a fully awake individual.
Measured: Day 0
Occurrence of sedation and agitation
Occurrence of sedation and agitation during the c-section assessed by the Richmond Agitation-Sedation scale (RASS).
This score is based on the observation of the patient It has 10 stages ranging from +4 (combative patient) to -5 (patient who cannot be woken up).
Measured: Day 0
Assessment of fetal well-being
Evaluation of fetal well-being by fetal heartbeat, by the Apgar score at 1, 3 and 5 minutes of life, and study of the pH in the umbilical cord, a pH value <7.2 defines fetal distress.
Measured: Day 0
Quality of ultrasound images
Assessment of obtaining views (parasternal long-axis view, parasternal short-axis view, apical 4-chamber view, subcostal).
Interpretability of the measurements obtained.
Measured: Day 0
Relative or absolute hypovolemia
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy.
To note the parameters suggestive of relative or absolute hypovolaemia: inferior vena cava diameter < 8 mm; "kissing sign" of the left ventricle, defined as à end-systolic collapse of the left ventricle; E/A ratio < 1.
Measured: Day 0
Right ventricle systolic or diastolic dysfunction
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy.
Right ventricle systolic function: measurement of the TAPSE (tricuspid annular plane systolic excursion; presence of a paradoxical septal motion (yes/no).
Right ventricle diastolic function: presence of right ventricle dilation defined as end-diastolic right ventricle area (EDRVA) / end-diastolic left ventricle area (EDLVA) > 0.6; "severe" dilatation is defined as a ratio > 1.
Measured: Day 0
Left ventricle systolic and diastolic dysfunction
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy.
Left ventricle systolic function:
left ventricle ejection fraction (LVEF) - apical-4-chamber view - defined as LVEF = (EDLVA-ESLVA)/EDLVA Left ventricle shortening fraction (LVSF) - parasternal short-axis view - defined as LVSF = (EDLVA-ESLVA)/EDLVA MAPSE (mitral annular plane systolic excursion
Left ventricle diastolic function:
Mitral flow profile: E wave / A wave ratio Left atrium area (cm²)
Measured: Day 0
Pericardial effusion
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy.
Measurement of the size (in mm) of the pericardial effusion (left and right ventricles lateral walls).
Measured: Day 0
Maternal comfort during the passive leg raising
Assessment of the maternal comfort during the passive leg raising test with a numerical scale (from 0: maximal discomfort to 10: maximal comfort).
Measured: Day 0
Heart rate
Association of increased up heart rate and total dose of neosynephrine at the end of the c-section.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start3 Feb 2021
- Primary completion3 Aug 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CesareanStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Xavier Repessé, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisHawa Keita-Meyer, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133271
- Sponsor's protocol ID
- APHP210937
- Other IDs
- 2021-A01099-32
- Acronym
- EDLIDL
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.
- ClinicalTrials.gov ID
- NCT05133271
- Acronym / sponsor ID
- EDLIDL / APHP210937
- Conditions
- Cesarean, Spinal Anesthesia
- Keywords
- Passive leg raise test (PLR), Cesarean section, Spinal anesthesia, Maternal arterial hypotension, Phenylephrine requirements, Norepinephrine requirements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 24 Nov 2021 (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 anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Detailed description
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia.
Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Patients will have a clinical hemodynamic and echocardiographic evaluation, before performing the spinal anesthesia, before and after the passive leg raise test.
Then, the patients will benefit from a clinical hemodynamic evaluation during the preparation of the parturient in the operating room and finally after the completion of the spinal anesthesia and until the clamping of the umbilical cord.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scheduled cesarean section | Experimental | Other: Clinical hemodynamic and echocardiographic evaluationPatient with scheduled cesarean section under spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
- Written informed consent
Key exclusion criteria (8 listed)
- No health insurance
- Urgent cesarean
- Failure of spinal anesthesia
- Free and informed consent impossible to obtain (especially due to a language barrier)
- Severe cardiovascular or neurovascular comorbidities
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 |
|---|---|---|
| Clinical hemodynamic and echocardiographic evaluationClinical hemodynamic and echocardiographic evaluation in two stages T1 and T2, before performing the spinal anesthesia, carried out by a doctor different from the doctor in charge of the parturient in the operating room to ensure the blind hemodynamic results before the spinal anesthesia, in particular those of the passive leg raise test (PLR) : 1. T1: clinico-echographic evaluation in dorsal decubitus position (45 °) with cushion under the right buttock. 2. T2: clinico-ultrasound evaluation after performing the PLR. Then, clinical hemodynamic evaluation during two periods T3 and T4: 3. T3: conditioning time of the parturient in the operating room during which clinical hemodynamic monitoring is set up and the basic values of arterial pressures (systolic, diastolic and mean) and heart rate are defined. 4. T4: period after performing spinal anesthesia until clamping of the umbilical cord. | Other | Scheduled cesarean section |
Primary outcome
Maternal arterial hypotension
Time frame: Day 0
Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)> 20% of baseline.
Positivity of passive leg raise test
Time frame: Day 0
A positive passive leg raise test is defined as an increase in the Subaortic Flow Velocity Time Integral of 10% or more. The increase in cardiac output is measured by a cardiac ultrasound.
Positive passive leg raise test performance
Time frame: Day 0
Performance of a positive passive leg raise test in predicting the onset of maternal arterial hypotension after spinal anesthesia. Significant performance will be defined by sensitivity and specificity > 90%.
13 secondary outcomes
Total dose of norepinephrine
Time frame: Day 0
Onset of severe arterial hypotension
Time frame: Day 0
Onset of nausea and vomiting
Time frame: Day 0
Occurrence of disturbances of consciousness
Time frame: Day 0
Occurrence of sedation and agitation
Time frame: Day 0
Assessment of fetal well-being
Time frame: Day 0
Quality of ultrasound images
Time frame: Day 0
Relative or absolute hypovolemia
Time frame: Day 0
Right ventricle systolic or diastolic dysfunction
Time frame: Day 0
Left ventricle systolic and diastolic dysfunction
Time frame: Day 0
Pericardial effusion
Time frame: Day 0
Maternal comfort during the passive leg raising
Time frame: Day 0
Heart rate
Time frame: Day 0
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 12 Sep 2025.
- Individual participant dataSharing planned: No
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Xavier Repessé, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Hawa Keita-Meyer, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical hemodynamic and echocardiographic evaluation in people with Cesarean and Spinal Anesthesia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 8 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 12 Sep 2025. 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 France. 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?
Maternal arterial hypotension (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.