Cesarean Section ComplicationsNCT03410199
Ultrasound Evaluation of Inferior Vena Cava Compression During Elective Cesarean Delivery.
An observational study of Cesarean Section Complications, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2018to 31 Mar 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Third trimester parturients with a normal pregnancy and a planned cesarean delivery under spinal anesthesia
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Evaluation of Inferior Vena Cava Compression During Elective Cesarean Delivery. Comparison of Tilt Versus No Tilt Positioning.
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.
Read the 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.
- Conditions
- Cesarean Section Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
Collapsibility index of the inferior vena cava before spinal anesthesia.
Comparison of the collapsibility index of the inferior vena cava with and without a tilt before spinal anesthesia.
Measured: Day 0
Calf versus arm transcutaneous saturation
Comparison of the calf versus arm transcutaneous saturation values in the tilt versus supine positions before and after spinal anesthesia
Measured: Day 0
Impact of the tilt versus no tilt positioning on the Apgar score
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.
Measured: 1 hour
Impact of the tilt versus no tilt positioning on the umbilical cord pH
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start29 Jan 2018
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Zaphiratos, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Valerie Zaphiratos, MD, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410199
- Sponsor's protocol ID
- 2018-1196
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2018
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34212308
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Inferior Vena Cava Compression During Elective Cesarean Delivery. Comparison of Tilt Versus No Tilt Positioning.
- ClinicalTrials.gov ID
- NCT03410199
- Acronym / sponsor ID
- 2018-1196
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 25 Jan 2018 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Third trimester parturients with a normal pregnancy and a planned cesarean delivery under spinal anesthesia
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Collapsibility index of the inferior vena cava before spinal anesthesia.
Time frame: Day 0
Calf versus arm transcutaneous saturation
Time frame: Day 0
Impact of the tilt versus no tilt positioning on the Apgar score
Time frame: 1 hour
Impact of the tilt versus no tilt positioning on the umbilical cord pH
Time frame: 1 month
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 14 Apr 2021.
- Derived from this study: PubMed 34212308Gagne 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.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Valerie Zaphiratos, MD principal investigator
Ciusss de L'Est de l'Île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 5 inclusion and 11 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 14 Apr 2021. 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 Canada. 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?
Collapsibility index of the inferior vena cava after spinal anesthesia. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410199, which also lists 1 linked publication.
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 14 Apr 2021.