An observational study in Elective Cesarean Section and Preeclampsia, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Mansoura University · Observational
Preeclampsia is a multifocal syndrome reported in 2-8 % of pregnancies. It is diagnosed in the second half of pregnancy by two separate measurements of systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg in the same arm and proteinuria >300 mg in 24 h urine collection. The risk for serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage is 10 to 30 fold higher among parturients with severe preeclampsia.
Severe preeclampsia is defined by one or more of the following clinical features: severe hypertension (systolic arterial pressure 160 mmHg and/or diastolic arterial pressure 110 mmHg on more than one occasion at least 4 h apart while the patient is on bed rest, renal dysfunction (serum creatinine >1.1mg/dl or doubling of serum creatinine in the absence of another renal disease, platelet count less than \<100,000 mm3, acute pulmonary edema, epigastric pain not responding to medical treatment, new-onset cerebral and visual manifestation, hemolysis, elevated liver enzymes and low platelet count syndrome (HELLP syndrome)
Fluid resuscitation is a key determinant in the management of these parturients. Hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. In this setting, the use of noninvasive hemodynamic monitoring is associated with reduced mortality.
Point-of-care lung ultrasonography is used in many critical care settings as the initial diagnostic imaging study for patients with respiratory symptoms. It is highly sensitive for the diagnosis of pulmonary edema which may occur even without cardiomyopathy or heart failure.
The IVC is a highly compliant vessel that changes its diam¬eter in parallel with changes in blood volume and central venous pressure. Measurement of IVC diameter and col¬lapsibility index using ultrasound through a subcostal approach has been investigated in patients of various settings. The IVC-CI imaging technique may be used to assess the volume status in healthy parturients undergoing routine cesarean delivery as well as in high-risk parturients as preeclampsia.
Cerebral edema is predominantly vasogenic and may be related to the failure of cerebral autoregulation with subsequent hyperperfusion, blood-brain barrier disruption, and endothelial cell dysfunction. Ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of raised ICP.
903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 100 is below the median of 160 across 389 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The calculated sample size of the study will be 70 parturients at 5% level of significance and 80 % power, using the following formula:
N= (Z1-α/2+Z1-β) ² σ1* σ2 / δ ² *2 Z1-α/2 = 1.96 Z1-β= 0.842 σ = SD (8, 9) δ = Expected difference to be detected before and after delivery (4). α = Level of acceptability of a false positive result (level of significance=0.05).
β = Level of acceptability of a false negative result (0.20).
1- β= power (0.80).The sample size will be increased to 100 parturients to compensate for protocol failures with incomplete data and to increase the power of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Procedure: Spinal Anesthesia · Drug: Intrathecal Bupivacaine · Drug: Intrathecal Fentanyl · Procedure: Cesarean Delivery · Radiation: lung ultrasound scans · Other: Ultrasound Assessment of the Inferior Vena Cava · Other: Optic nerve sheath diameter · Drug: ringer acetate · Drug: Intravenous Ephedrine · Drug: Intravenous Syntocinon
Performed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Fentanyl 15 μg will be administered in the subarachnoid space
Lower segment cesarean section using the Pfannenstiel incision
lung ultrasound scans will be performed while the patient is in the supine position with left lateral tilt by 30 degrees using a 2-5 MHz curved array transducer. The echo comet score (ECS) which corresponds to the amount of EVLW will be obtained by the 28-rib interspaces technique. An increased amount of (EVLW) is diagnosed by multiple B-lines or 'comet tails' which are defined as discrete laser-like vertical hyperechoic reverberation artifacts that arise from the pleural line and extend to the bottom of the screen without fading and move synchronously with lung sliding. The sum of the B-lines found on each of the 28 chest-wall areas yields the ECS.
The IVC largest and smallest diameters will be measured proximal to the opening of the M-mode using s2-4 MHz transducer placed longitudinally in the subcostal region.
Optic nerve sheath diameter measurement will be conducted in two axes of transverse and oblique sagittal using a 12-4MHz linear array transducer. Depth of the optic nerve will be localized and marked at 3 mm behind the retinal and optic nerve junction transverse diameter of optic nerve sheath will be calculated. The reported ONSD corresponds to the mean of the four values obtained for each patient transverse and sagittal plane for both eyes.
Drug pages: Sodium Chloride · Sodium Acetate · Potassium Chloride · Calcium Chloride · Magnesium Chloride
1000 ml ringer acetate will be administered over 2 hours.
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution.
Ultrasonographic fluid assessment
Detection of change in overall number of B lines (ECS) by lung ultrasound
Time frame: Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.
Urine output
total urine output at 2 hours after spinal anesthesia
Time frame: For 2 hours after spinal anesthesia
Oliguria
Incidence of oliguria defined as a total urine output \<60 mL/hr
Time frame: For 2 hours after spinal anesthesia
Ephedrine use
total ephedrine dose
Time frame: Intraoperative
Intraoperative bradycardia
Incidence of bradycardia (Heart rate \<50 beats/minute)
Time frame: Intraoperative
Incidence of nausea and vomiting.
Incidence of nausea and/or vomiting as reported by the patient
Time frame: Intraoperative
Difference between overall number of b lines
difference between overall number of b lines preoperative(baseline) and at 1 hour after spinal anesthesia.
Time frame: baseline and 1hour post spinal
Inferior Vena Caval Diameters
Maximum, minimum inferior vena cava diameters and inferior vena cava collapsibility index changes over time.
Time frame: Baseline, and at 1 and 2 hours post-spinal
Difference between optic nerve sheath diameter
optic nerve sheath diameter changes over time.
Time frame: baseline,at 1hour and at 2 hours of spinal anesthesia.
Neonatal Apgar score
neonatal Apgar score to assess neonatal wellbeing at 5 min after delivery
Time frame: 5 min after delivery
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will be available following publication for life-long.
Access criteria: the data will be accessible to the investigators .and the PRS administrators with hiding the identifiers for the patients
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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