Assessment of Volume Status in Preeclampsia Post- SpinalAnasthesia:Utilizing Ultrasound " Evaluation of Lung and Inferior Vena Cava" (AComparative)

Assessment of Volume Status in Preeclampsia Post- SpinalAnasthesia:Utilizing Ultrasound " Evaluation of Lung and Inferior Vena Cava"AComparative Study

Primary aim Assess the accuracy and reliability of ultrasound evaluation of lung and inferior vena cava in determining volume status post-spinal anesthesia in pre-eclampsia patients.

Measure the correlation between ultrasound findings and the traditional methods.

Determine if ultrasound evaluation can predict fluid responsiveness and guide fluid management in this population.

Secondary aim

The secondary outcomes are:

Investigate the association between volume status as determined by ultrasound and clinical outcomes such as maternal morbidity, neonatal outcomes, and length of hospital stay.

Explore the feasibility and practicality of incorporating ultrasound evaluation into routine clinical practice for volume assessment in pre-eclampsiapatients post-spinal anesthesia.

Consider patient satisfaction and acceptance of ultrasound evaluation compared to traditional methods.

Study Overview

• Status: Active, not recruiting
• Conditions: Preeclampsia
• Intervention / Treatment: Device: Ultrasound lung; Drug: Intrathecal bupivacane; Device: ultrasound for IVC diameter

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Shibīn al Kawm, Egypt
    • Menofia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Age 20 to35 years
• Gestational age 36 weeks
• Body mass index (BMI) <35kg/m2.
• Mild preeclampsia

Exclusion criteria :

• Age <19 or >40 years, gestational age <36 weeks, body mass index (BMI)≥40kg/m2.
• Women presenting in emergency delivery.
• Patient with other co morbidity sever cardiovascular or central nervous disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ultrasound lung; Lung ultrasound will be performed using 2-5 MHz transducer, curved array (SonoAce R3; Samsung Medison, Seoul, South Korea). The 28-rib interspacestechniquewill used to calculate the Echo Comet Score (ECS), which divides the chest wall into 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) in each hemithorax, divided by the parasternal, midclavicular, anterior, and mid axillary lines. Multiple B-lines or "comet tails" can indicate an increased amount of extravascular lung water (EVLW).B-lines are vertical hyperechoic reverberation artifactsthat start from the pleural line and reach the bottom of the screen without fading and move synchronously with lung sliding. The ECS, which represents the amount of EVLW, is calculated by adding the overall number of B-lines observed on each of the 28 chest-wall locations and corresponding to the degree of pulmonary congestion. Scans are longitudinal with	Device: Ultrasound lung; Lung Ultrasound (LUS) Examination: Lung ultrasound will be performed using 2-5 MHz transducer, curved array (SonoAce R3; Samsung Medison, Seoul, South Korea). The 28-rib interspacestechniquewill used to calculate the Echo Comet Score (ECS), which divides the chest wall into 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) in each hemithorax, divided by the parasternal, midclavicular, anterior, and mid axillary lines. Multiple B-lines or "comet tails" can indicate an increased amount of extravascular lung water (EVLW).B-lines are vertical hyperechoic reverberation artifactsthat start from the pleural line and reach the bottom of the screen without fading and move synchronously with lung sliding. The ECS, which represents the amount of EVLW, is calculated by adding the overall number of B-lines observed on each of the 28 chest-wall locations and corresponding to the degree of pulmonary conges; Drug: Intrathecal bupivacane; an anaesthesiologist with considerable experiencewilluse a 25-gauge spinal needle to provide spinal anesthesia at the L3-L4 or L4-L5 interspace, while the patient is in a sitting position; 12.5 mg ofhyperbaric bupivacaine (2.5 mL 0.5%) and 15 μg of fentanyl will be injected intrathecally
Active Comparator: Mild preeclampsia; Obstetricians and Gynaecologists (ACOG) guidelines as blood pressure ≥140/90 mmHg after 20 weeks of gestation and proteinuria ≥300 mg/24h or ≥1+ dipstick in urine9.	Device: Ultrasound lung; Lung Ultrasound (LUS) Examination: Lung ultrasound will be performed using 2-5 MHz transducer, curved array (SonoAce R3; Samsung Medison, Seoul, South Korea). The 28-rib interspacestechniquewill used to calculate the Echo Comet Score (ECS), which divides the chest wall into 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) in each hemithorax, divided by the parasternal, midclavicular, anterior, and mid axillary lines. Multiple B-lines or "comet tails" can indicate an increased amount of extravascular lung water (EVLW).B-lines are vertical hyperechoic reverberation artifactsthat start from the pleural line and reach the bottom of the screen without fading and move synchronously with lung sliding. The ECS, which represents the amount of EVLW, is calculated by adding the overall number of B-lines observed on each of the 28 chest-wall locations and corresponding to the degree of pulmonary conges; Drug: Intrathecal bupivacane; an anaesthesiologist with considerable experiencewilluse a 25-gauge spinal needle to provide spinal anesthesia at the L3-L4 or L4-L5 interspace, while the patient is in a sitting position; 12.5 mg ofhyperbaric bupivacaine (2.5 mL 0.5%) and 15 μg of fentanyl will be injected intrathecally
Active Comparator: Intrathecal bupivacaine	Device: Ultrasound lung; Lung Ultrasound (LUS) Examination: Lung ultrasound will be performed using 2-5 MHz transducer, curved array (SonoAce R3; Samsung Medison, Seoul, South Korea). The 28-rib interspacestechniquewill used to calculate the Echo Comet Score (ECS), which divides the chest wall into 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) in each hemithorax, divided by the parasternal, midclavicular, anterior, and mid axillary lines. Multiple B-lines or "comet tails" can indicate an increased amount of extravascular lung water (EVLW).B-lines are vertical hyperechoic reverberation artifactsthat start from the pleural line and reach the bottom of the screen without fading and move synchronously with lung sliding. The ECS, which represents the amount of EVLW, is calculated by adding the overall number of B-lines observed on each of the 28 chest-wall locations and corresponding to the degree of pulmonary conges; Drug: Intrathecal bupivacane; an anaesthesiologist with considerable experiencewilluse a 25-gauge spinal needle to provide spinal anesthesia at the L3-L4 or L4-L5 interspace, while the patient is in a sitting position; 12.5 mg ofhyperbaric bupivacaine (2.5 mL 0.5%) and 15 μg of fentanyl will be injected intrathecally
Active Comparator: ultrasound for IVC diameter; scanned using a 2-4 MHz phased array transducer implanted longitudinally in the subcostal region. Duringnormalspontaneous breathing, the maximum and minimum IVC diameters were measured using the Mmodeabout 2 cm proximal (caudal) to the ostium of the right atrium and immediately proximal to the junction with the hepatic vein.	Device: ultrasound for IVC diameter; The IVC was scanned using a 2-4 MHz phased array transducer implanted longitudinally in the subcostal region. Duringnormalspontaneous breathing, the maximum and minimum IVC diameters were measured using the Mmodeabout 2 cm proximal (caudal) to the ostium of the right atrium and immediately proximal to the junction with the hepatic vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung ultrasound and IVC diameter	All baseline ultrasound examinations were performed by the principal investigator with the study patients lying supine with slight left lateral table-tilt. Subsequently, ultrasound examinations at 1hourwill be performed with the study patients lying supi
Primary aim Assess the accuracy and reliability of ultrasound evaluation of lung and inferior vena cava in determining volume status post-spinal anesthesia in pre-eclampsia patients. Measure the correlation between ultrasound findings and the traditional	2 hour

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): July 20, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 7/2024ANET27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes