Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.

NCT05133271 | Completed

• 2 other identifiers: APHP2109372021-A01099-32
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cesarean; Spinal Anesthesia

Keywords

Passive leg raise test (PLR); Cesarean section; Spinal anesthesia; Maternal arterial hypotension; Phenylephrine requirements; Norepinephrine requirements

Outcome Measures

Primary Outcomes (3)

• Maternal arterial hypotension

  Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)\> 20% of baseline.

  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.

  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%.

  Day 0

Secondary Outcomes (13)

• Total dose of norepinephrine

  Day 0

• Onset of severe arterial hypotension

  Day 0

• Onset of nausea and vomiting

  Day 0

• Occurrence of disturbances of consciousness

  Day 0

• Occurrence of sedation and agitation

  Day 0

Study Arms (1)

Scheduled cesarean section

EXPERIMENTAL

Patient with scheduled cesarean section under spinal anesthesia.

Other: Clinical hemodynamic and echocardiographic evaluation

Interventions

Clinical hemodynamic and echocardiographic evaluation OTHER

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) : 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.

Scheduled cesarean section

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient with scheduled cesarean section under spinal anesthesia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Study Officials

• Xavier Repessé, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Hawa Keita-Meyer, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 24, 2021
• Study Start: February 3, 2021
• Primary Completion: August 3, 2024
• Study Completion: August 3, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)