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NCT Number: NCT07514130

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Menofia University

Shibīn al Kawm, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound lung

Device

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

ultrasound for IVC diameter

Device

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.

Intrathecal bupivacane

Drug

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

Primary outcomes

  1. Lung ultrasound and IVC diameter

    Time frame: 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

  2. 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

    Time frame: 2 hour

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Acronym: AComparative

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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