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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410199
Recruitment Status : Unknown
Verified February 2018 by Valerie Zaphiratos, Ciusss de L'Est de l'Île de Montréal.
Recruitment status was:  Recruiting
First Posted : January 25, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Valerie Zaphiratos, Ciusss de L'Est de l'Île de Montréal

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.

Condition or disease
Cesarean Section Complications

Detailed Description:

Cesarean delivery (CD) is one of the most currently practiced surgeries in the world. In 2013, surgical deliveries represented 32.4% of births in the United States and 26.9% in Canada. Maternal hypotension is a frequent adverse event during CD under spinal anesthesia and can be detrimental to the fetus and mother. Many means have been studied to decrease the incidence of hypotension in this context such as crystalloid/colloid pre-loading and co-loading, vasopressors, and positioning.

Aortocaval compression of the inferior vena cava (IVC) by the gravid uterus is a major contributor to this hypotension and many positions on the operating table have been researched to decrease its influence.Current recommendations for term women undergoing cesarean delivery include left lateral 15 degree tilt in order to reduce aortocaval compression which may cause maternal hypotension and fetal compromise. However, a recent meta-analysis did not show conclusive evidence to favour the tilted versus the supine position. This is probably due to a compensatory mechanism involving venoconstriction of the lower limbs, raising venous pressure and causing flow through collateral channels. Supine hypotensive syndrome with clinically significant effects occurs in 8-10% of women at term, possibly due to less compensatory mechanisms.

Respiratory variations of the IVC diameter measured by an ultrasound may determine the best position on the operating table for term parturients during cesarean delivery. Large variations of IVC diameter during expiration and inspiration have been shown to be related to hypotension in non-pregnant patients.

The primary objective of our project is to compare the collapsibility index of the inferior vena cava during elective cesarean delivery after the administration of spinal anesthesia with a phenylephrine infusion. Each participant will be their own control.

20 patients scheduled for elective cesarean delivery will be included. Each participant will be her own control for the ultrasound measurements of the inferior vena cava, with and without a tilt before and after spinal anesthesia with a phenylephrine infusion. A transcutaneous oximetry monitor (NIRS) will be used in order to measure the upper versus lower body saturation difference. The newborn Apgar score and umbilical cord pH will be noted.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Ultrasound Evaluation of Inferior Vena Cava Compression During Elective Cesarean Delivery. Comparison of Tilt Versus No Tilt Positioning.
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section




Primary Outcome Measures :
  1. Collapsibility index of the inferior vena cava after spinal anesthesia. [ Time Frame: Day 0 ]
    Comparison of the collapsibility index of the inferior vena cava with and without a tilt after spinal anesthesia.


Secondary Outcome Measures :
  1. Collapsibility index of the inferior vena cava before spinal anesthesia. [ Time Frame: Day 0 ]
    Comparison of the collapsibility index of the inferior vena cava with and without a tilt before spinal anesthesia.

  2. Calf versus arm transcutaneous saturation [ Time Frame: Day 0 ]
    Comparison of the calf versus arm transcutaneous saturation values in the tilt versus supine positions before and after spinal anesthesia

  3. Impact of the tilt versus no tilt positioning on the Apgar score [ Time Frame: 1 hour ]
    Comparison of the Apgar scores of the newborn in regards to the mother's position on the operating table during the C-section: tilt versus supine.

  4. Impact of the tilt versus no tilt positioning on the umbilical cord pH [ Time Frame: 1 month ]
    Comparison of the umbilical cord pH of the newborn in regards to the mother's position on the operating table during the C-section: tilt versus supine.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Third trimester parturients with a normal pregnancy and a planned cesarean delivery under spinal anesthesia
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410199


Contacts
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Contact: Valerie Zaphiratos, MD 514 252-3426 valerie@zaphiratos.ca

Locations
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Canada, Quebec
Maisonneuve-rosemont Recruiting
Montréal, Quebec, Canada, H1T2M4
Contact: Maisonneuve-rosemont Gagné, MD    5147963484    marie4po@hotmail.com   
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Investigators
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Principal Investigator: Valerie Zaphiratos, MD Ciusss de L'Est de l'Île de Montréal

Additional Information:

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Responsible Party: Valerie Zaphiratos, MD, MSc, FRCPC, Assistant Professor, Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT03410199    
Other Study ID Numbers: 2018-1196
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No