An observational study in Pregnancy Related and Hypotension, Orthostatic, sponsored by Augusta University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Augusta University · Observational
The investigators propose this study to test the hypotheses that inferior vena cava (IVC) diameter can predict hypotension after labor analgesia (epidural, combined spinal-epidural) and neuraxial anesthesia for cesarean section (epidural, combined spinal-epidural and spinal block) in full-term pregnant patients.
After approval by the Institutional Review Board and patient consent, term pregnant patients (>37 week gestation) admitted to the obstetric service of Augusta University Medical Center, who require administration of neuraxial analgesia for labor or regional anesthesia for cesarean section, will be included in the study. The consent will be obtained by the attending, resident or medical student in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. Demographic variables (age, BMI, Gravity, parity and gestation weeks) and hemodynamic variables (MAP and HR) will be recorded. All patients will be lying in supine position, breathing spontaneously. The ultrasound examination will be performed before commencement of the neuraxial procedure and will be repeated two minutes after administration of the neuraxial anesthetic. Ultrasound measurements will be made with a Sonosite Edge (Sonosite Inc. USA) machine and a C60X curved linear phased array transducer (Sonosite Inc.) set to abdominal mode. All measurements will be made by two attending anesthesiologists (ERP and AR) who have experience in transthoracic echocardiography, and a resident who receives the basic instruction to measure IVC diameter. The medical student will be present during the procedure and will ensure that the study echocardiographic views are taken.
The IVC will be visualized using a paramedian long-axis view via a subcostal approach according to guidelines of the American Society of Echocardiography. A two-dimensional image of the IVC will be obtained and pulsed wave Doppler will be used to differentiate from the aorta. Variations in IVC diameters will be assessed with M-mode applied 2 cm. distal to the right atrium. To ensure consistent measurements, each operator will take three images. The best quality images are chosen. Maximum and minimum IVC diameters during a single respiratory cycle will be measured.
155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.
This study's enrollment of 42 is below the median of 50 across 34 observational studies indexed under Hypotension, Orthostatic.
Browse Hypotension, Orthostatic studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Term pregnant patients in labor who have labor epidural placement.
Exclusion criteria:
Patients with clinical indication of labor epidural will have IVC diameter measurement with ultrasound before and after the epidural placement
Diagnostic Test: Inferior vena cava ultrasound
Abdominal ultrasound to identify IVC between hepatic veins and right atrium. Measurement of dimensions throughout respiratory cycle (before and after labor epidural)
IVC diameter
IVC diameter in centimeters during respiratory cycle
Time frame: 10 minutes
Mean arterial pressure
Mean arterial pressure
Time frame: 30 minutes
Nausea
Nausea
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Augusta University