Ultrasound Evaluation of Inferior Vena Cava Compression During Elective Cesarean Delivery.
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|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
|Condition or disease|
|Cesarean Section Complications|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||20 participants|
|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|
- 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.
- 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.
- 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
- 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.
- 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.
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
|Contact: Valerie Zaphiratos, MD||514 email@example.com|
|Montréal, Quebec, Canada, H1T2M4|
|Contact: Maisonneuve-rosemont Gagné, MD 5147963484 firstname.lastname@example.org|
|Principal Investigator:||Valerie Zaphiratos, MD||Ciusss de L'Est de l'Île de Montréal|