PreeclampsiaEarly Phase 1AComparativeNCT07514130
Assessment of Volume Status in Preeclampsia Post- SpinalAnasthesia:Utilizing Ultrasound " Evaluation of Lung and Inferior Vena Cava"
A Early Phase 1 study testing Ultrasound lung, ultrasound for IVC diameter and Intrathecal bupivacane in people with Preeclampsia, run by Menoufia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Ultrasound lung, ultrasound for IVC diameter and Intrathecal bupivacane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to35 years
- Gestational age 36 weeks
- Body mass index (BMI) <35kg/m2.
- Mild preeclampsia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Preeclampsia
- Being tested
- Ultrasound lung, ultrasound for IVC diameter, Intrathecal bupivacane
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound lungDevice
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 diameterDevice
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 bupivacaneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| ultrasound lung | Active comparator | 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 Receives: Device: Ultrasound lung; Drug: Intrathecal bupivacane |
| Mild preeclampsia | Active comparator | 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. Receives: Device: Ultrasound lung; Drug: Intrathecal bupivacane |
| Intrathecal bupivacaine | Active comparator | Not described Receives: Device: Ultrasound lung; Drug: Intrathecal bupivacane |
| ultrasound for IVC diameter | Active comparator | 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. Receives: Device: ultrasound for IVC diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound and IVC diameter
Measured: 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
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Aug 2024
- Primary completion20 Jul 2025
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514130
- Sponsor's protocol ID
- 7/2024ANET27
- Acronym
- AComparative
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Volume Status in Preeclampsia Post- SpinalAnasthesia:Utilizing Ultrasound " Evaluation of Lung and Inferior Vena Cava"AComparative Study
- ClinicalTrials.gov ID
- NCT07514130
- Acronym / sponsor ID
- AComparative / 7/2024ANET27
- Conditions
- Preeclampsia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ultrasound lung | Active comparator | Device: Ultrasound lung, Drug: Intrathecal bupivacaneLung 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 |
| Mild preeclampsia | Active comparator | Device: Ultrasound lung, Drug: Intrathecal bupivacaneObstetricians 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. |
| Intrathecal bupivacaine | Active comparator | Device: Ultrasound lung, Drug: Intrathecal bupivacane |
| ultrasound for IVC diameter | Active comparator | Device: ultrasound for IVC diameterscanned 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to35 years
- Gestational age 36 weeks
- Body mass index (BMI) <35kg/m2.
- Mild preeclampsia
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound lungLung 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 | Device | Intrathecal bupivacaine, Mild preeclampsia, ultrasound lung |
| ultrasound for IVC diameterThe 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. | Device | ultrasound for IVC diameter |
| Intrathecal bupivacanean 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 | Drug | Intrathecal bupivacaine, Mild preeclampsia, ultrasound lung |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultrasound lung, ultrasound for IVC diameter and Intrathecal bupivacane in people with Preeclampsia, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.