NCT04370847

Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: —

Summary

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)

Detailed description

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.

Conditions

• Elective Cesarean Section
• Preeclampsia

Interventions

Type	Name	Description
PROCEDURE	Spinal Anesthesia	Performed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle
DRUG	Intrathecal Bupivacaine	Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
DRUG	Intrathecal Fentanyl	Fentanyl 15 μg will be administered in the subarachnoid space
PROCEDURE	Cesarean Delivery	Lower segment cesarean section using the Pfannenstiel incision
RADIATION	lung ultrasound scans	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.
OTHER	Ultrasound Assessment of the Inferior Vena Cava	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.
OTHER	Optic nerve sheath diameter	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	ringer acetate	1000 ml ringer acetate will be administered over 2 hours.
DRUG	Intravenous Ephedrine	Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
DRUG	Intravenous Syntocinon	Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2020-05-01
• Last updated: 2024-11-13

Locations

1 site across 1 country: Egypt