Ultrasound Evaluation of Inferior Vena Cava Compression During Elective Cesarean Delivery.

NCT03410199 | Completed

• 1 other identifier: 2018-1196
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aortocaval compression by the gravid uterus during the third trimester contributes to decreased venous return to the heart. Neuraxial anesthesia reinforces this hypotension by causing a vasodilatation and venous pooling of blood in the lower limbs. The current practice is to tilt the parturient 15 degrees on the operating table after neuraxial anesthesia in order to decrease this hypotension. Recent meta-analysis suggests there is no conclusive evidence to support the tilt position. The goal of our study is to compare ultrasound vena cava variation measurements in the supine versus the tilt position in third trimester parturients undergoing elective cesarean delivery.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Collapsibility index of the inferior vena cava after spinal anesthesia.

  Comparison of the collapsibility index of the inferior vena cava with and without a tilt after spinal anesthesia.

  Day 0

Secondary Outcomes (4)

• Collapsibility index of the inferior vena cava before spinal anesthesia.

  Day 0

• Calf versus arm transcutaneous saturation

  Day 0

• Impact of the tilt versus no tilt positioning on the Apgar score

  1 hour

• Impact of the tilt versus no tilt positioning on the umbilical cord pH

  1 month

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Third trimester parturients with a normal pregnancy and a planned cesarean delivery under spinal anesthesia

You may qualify if:

• ASA 1-2
• Elective cesarean delivery
• Spinal anesthesia
• At least 37 weeks of gestational age
• French speaking patients (able to read and sign the consent form)

You may not qualify if:

• Inability to obtain adequate ultrasound mesures before or after spinal anesthesia
• Cardiopathy
• Unexpected difficult spinal anesthesia requiring general anesthesia
• Unexpected complications requiring strong hemodynamic support (transfusions, volume challenges, multiple vasopressors, inotropic drugs...) or requiring anti-hypertensive medication (including magnesium)
• Any contraindication or patient's refusal for spinal anesthesia (e.g. coagulopathy)
• Morbid obesity (IMC over 40 at the time of delivery)
• Active labour
• Emergency cesarean delivery
• Fetal abnormality or prematurity (under 37 weeks of gestational age)
• Multiple gestation
• Inability to cooperate due to langage or physical/mental incapacity

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-rosemont

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• Gagne MP, Richebe P, Loubert C, Drolet P, Gobert Q, Denault A, Zaphiratos V. Ultrasound evaluation of inferior vena cava compression in tilted and supine term parturients. Can J Anaesth. 2021 Oct;68(10):1507-1513. doi: 10.1007/s12630-021-02051-w. Epub 2021 Jul 1.

  PMID: 34212308 DERIVED

Study Officials

• Valerie Zaphiratos, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCPC, Assistant Professor

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 25, 2018
• Study Start: January 29, 2018
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)