Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

Completed

• Conditions: Elective Cesarean Section; Preeclampsia
• Interventions: 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

• Registration Number: NCT04370847
• Lead Sponsor: Mansoura University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-01
• Study Start: 2020-06-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Singleton pregnancy.
• 32 - 41 weeks gestational age.
• Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
• Elective cesarean delivery under spinal anesthesia.

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Exclusion Criteria

• Body mass index (BMI) ≥40 kg/m2.
• Significant cardiovascular disease
• Other obstetrical problems
• Other uteroplacental problems
• Abruption placenta.
• Already treated for acute lung pathology prior to enrollment.
• Contraindications to spinal anesthesia.
• INR >1.5 or PLT<100,000 /mm3.
• Women presenting in labor.
• Previous thoracic surgery.
• Previous ocular surgery
• Ocular trauma
• Glaucoma.
• Preoperative pulmonary disease:
• Increased serum creatinine level ≥1.1 mg/dL.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Ultrasound (LUS) Examination	Intrathecal Bupivacaine	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Intravenous Ephedrine	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Spinal Anesthesia	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Intrathecal Fentanyl	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Cesarean Delivery	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	lung ultrasound scans	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Optic nerve sheath diameter	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Ultrasound Assessment of the Inferior Vena Cava	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	ringer acetate	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Lung Ultrasound (LUS) Examination	Intravenous Syntocinon	Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients

Primary Outcome Measures

Name	Time	Method
Ultrasonographic fluid assessment	Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.	Detection of change in overall number of B lines (ECS) by lung ultrasound

Secondary Outcome Measures

Name	Time	Method
Incidence of nausea and vomiting.	Intraoperative	Incidence of nausea and/or vomiting as reported by the patient
Difference between overall number of b lines	baseline and 1hour post spinal	difference between overall number of b lines preoperative(baseline) and at 1 hour after spinal anesthesia.
Inferior Vena Caval Diameters	Baseline, and at 1 and 2 hours post-spinal	Maximum, minimum inferior vena cava diameters and inferior vena cava collapsibility index changes over time.
Difference between optic nerve sheath diameter	baseline,at 1hour and at 2 hours of spinal anesthesia.	optic nerve sheath diameter changes over time.
Neonatal Apgar score	5 min after delivery	neonatal Apgar score to assess neonatal wellbeing at 5 min after delivery
Urine output	For 2 hours after spinal anesthesia	total urine output at 2 hours after spinal anesthesia
Oliguria	For 2 hours after spinal anesthesia	Incidence of oliguria defined as a total urine output \<60 mL/hr
Ephedrine use	Intraoperative	total ephedrine dose
Intraoperative bradycardia	Intraoperative	Incidence of bradycardia (Heart rate \<50 beats/minute)

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, DK, Egypt