Cesarean Section ComplicationsNCT03181776
Hemodynamic Effect of Left Tilting in Cesarean Delivery
A study testing left lateral tilting in 15 degrees, left lateral tilting in 30 degrees and supine position in people with Cesarean Section Complications and Spinal Anesthetic Complications, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Spinal Anesthetic Complications
- What is being tested?
- left lateral tilting in 15 degrees, left lateral tilting in 30 degrees and supine position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2017to 5 Dec 2018
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- full term parturients scheduled for cesarean delivery
Who cannot join
- BMI > 35 Kg/m2, polyhydramnios, history of impaired cardiac contractility, valvular heart disease, cardiac arrhythmias, hypertensive pregnancy disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
ahmed Hasanin, Lecturer, +2010095076954, ahmedmohamedhasanin@gmail.com
About this study
Official title: Hemodynamic Effect of Three Randomized Angles of Left Tilting After Spinal Anesthesia for Cesarean Delivery
The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block
Read the detailed description
Aortocaval compression (ACC) by the gravid uterus is a known physiological phenomenon that is classically claimed to cause supine hypotension in full term pregnant women. ACC has been also mentioned as a possible cause of post-spinal hypotension (PSH) in parturients undergoing cesarean section (CS); however, the evidence for the value of left lateral tilting of parturient in improving hemodynamics is not clear.
The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block (SAB).
Hemodynamic variables will be taken before SAB in three angles (zero angle, 15 degree angle, and 30 degree angles) of left lateral tilt.
Patients will receive normal SAB after prophylactic vasopressor adminstration (either 15 mg ephedrine or 1.5 mcg/Kg phenylephrine intravenous bolus) then hemodynamic variables will measured again after SAB in the same three angles. The sequence of the tilting angles will be randomized.
Another measure will be taken after delivery of the fetus. SAB will be done in sitting position under complete asepsis using 25 g spinal needle with crystalloid infusion of 500 mL. SAB will be achieved by intrathecal injection of 10 mg hyperbaric Bupivacaine plus 25ug fentanyl. Success of SAB will be tested within five minutes after drug injection. SAB will be considered successful if adequate block reached T4 dermatome.
Cardiac output and stroke volume will be measured using electrical cardiometry device.
- Being tested
- left lateral tilting in 15 degrees, left lateral tilting in 30 degrees, supine position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left lateral tilting in 15 degreesOther
The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge
left lateral tilting in 30 degreesOther
The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge
supine positionOther
The mother will be placed in standard supine position
| Study group | Role | What they receive |
|---|---|---|
| left lateral tilting arm | Experimental | all patients will be put in three angles of left lateral tilt in randomized order (supine position - left lateral tilting in 15 degrees - and left lateral tilting in 30 degrees) and the hemodynamic data will be compared in the three angles. Receives: Other: left lateral tilting in 15 degrees; Other: left lateral tilting in 30 degrees; Other: supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Cardiac output in liters per minute measured by electrical cardiometry
Measured: 30 minutes after spinal anesthesia in different angles of left lateral tilting
Secondary outcomes (9)
cardiac output
Cardiac output in liters per minute measured by electrical cardiometry
Measured: before spinal anesthesia in different angles of left lateral tilting
mean arterial blood pressure
mean arterial blood pressure measured by non-invasive monitor
Measured: before spinal anesthesia in different angles of left lateral tilting
mean arterial blood pressure
mean arterial blood pressure measured by non-invasive monitor
Measured: 30 minutes after spinal anesthesia in different angles of left lateral tilting
stroke volume
stroke volume in milliliters measured by electrical cardiometry
Measured: before spinal anesthesia in different angles of left lateral tilting
stroke volume
stroke volume in milliliters measured by electrical cardiometry
Measured: 30 minutes after spinal anesthesia in different angles of left lateral tilting
systemic vascular resistance
measured in mmHg × min / mL by electrical cardiometry
Measured: before spinal anesthesia in different angles of left lateral tilting
systemic vascular resistance
measured in mmHg × min / mL by electrical cardiometry
Measured: 30 minutes after spinal anesthesia in different angles of left lateral tilting
heart rate
measured in beat per minute
Measured: before spinal anesthesia in different angles of left lateral tilting
heart rate
measured in beat per minute
Measured: 30 minutes after spinal anesthesia in different angles of left lateral tilting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start22 Jun 2017
- Primary completion25 Nov 2018 (estimated)
- Study completion5 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will investigate the effect of different tilting angles on the hemodynamics of full term pregnants before and after spinal anesthesia
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181776
- Sponsor's protocol ID
- N-36-2016
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effect of Three Randomized Angles of Left Tilting After Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03181776
- Acronym / sponsor ID
- N-36-2016
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 25 Nov 2018 (estimated)
- Study completion
- 5 Dec 2018 (estimated)
- First posted
- 9 Jun 2017 (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.
The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block
Detailed description
Aortocaval compression (ACC) by the gravid uterus is a known physiological phenomenon that is classically claimed to cause supine hypotension in full term pregnant women. ACC has been also mentioned as a possible cause of post-spinal hypotension (PSH) in parturients undergoing cesarean section (CS); however, the evidence for the value of left lateral tilting of parturient in improving hemodynamics is not clear.
The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block (SAB).
Hemodynamic variables will be taken before SAB in three angles (zero angle, 15 degree angle, and 30 degree angles) of left lateral tilt.
Patients will receive normal SAB after prophylactic vasopressor adminstration (either 15 mg ephedrine or 1.5 mcg/Kg phenylephrine intravenous bolus) then hemodynamic variables will measured again after SAB in the same three angles. The sequence of the tilting angles will be randomized.
Another measure will be taken after delivery of the fetus. SAB will be done in sitting position under complete asepsis using 25 g spinal needle with crystalloid infusion of 500 mL. SAB will be achieved by intrathecal injection of 10 mg hyperbaric Bupivacaine plus 25ug fentanyl. Success of SAB will be tested within five minutes after drug injection. SAB will be considered successful if adequate block reached T4 dermatome.
Cardiac output and stroke volume will be measured using electrical cardiometry device.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will investigate the effect of different tilting angles on the hemodynamics of full term pregnants before and after spinal anesthesia
| Arm | Type | Receives |
|---|---|---|
| left lateral tilting arm | Experimental | Other: left lateral tilting in 15 degrees, Other: left lateral tilting in 30 degrees, Other: supine positionall patients will be put in three angles of left lateral tilt in randomized order (supine position - left lateral tilting in 15 degrees - and left lateral tilting in 30 degrees) and the hemodynamic data will be compared in the three angles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- full term parturients scheduled for cesarean delivery
Key exclusion criteria (1 listed)
- BMI > 35 Kg/m2, polyhydramnios, history of impaired cardiac contractility, valvular heart disease, cardiac arrhythmias, hypertensive pregnancy disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left lateral tilting in 15 degreesThe mother will be placed in left lateral tilted position (15 degrees) using a standard wedge | Other | left lateral tilting arm |
| left lateral tilting in 30 degreesThe mother will be placed in left lateral tilted position (30 degrees) using a standard wedge | Other | left lateral tilting arm |
| supine positionThe mother will be placed in standard supine position | Other | left lateral tilting arm |
Primary outcome
Cardiac output
Time frame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
Cardiac output in liters per minute measured by electrical cardiometry
9 secondary outcomes
cardiac output
Time frame: before spinal anesthesia in different angles of left lateral tilting
mean arterial blood pressure
Time frame: before spinal anesthesia in different angles of left lateral tilting
mean arterial blood pressure
Time frame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
stroke volume
Time frame: before spinal anesthesia in different angles of left lateral tilting
stroke volume
Time frame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
systemic vascular resistance
Time frame: before spinal anesthesia in different angles of left lateral tilting
systemic vascular resistance
Time frame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
heart rate
Time frame: before spinal anesthesia in different angles of left lateral tilting
heart rate
Time frame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Ahmed Mukhtar, Professor study director
Head of research committee section in anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left lateral tilting in 15 degrees, left lateral tilting in 30 degrees and supine position in people with Cesarean Section Complications and Spinal Anesthetic Complications, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Shash, Professor (+201001033999, shashahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: 30 minutes after spinal anesthesia in different angles of left lateral tilting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2018.