Pre-EclampsiaNCT07786246
Internal Jugular Vein Collapsibility Index for Volume Status Assessment in Preeclampsia in Correlation With Normotensive Parturients
An observational study of Pre-Eclampsia and Preeclampsia, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to assess and analyze volume status in preeclamptic patients and compare these parameters with those of normotensive pregnant ones based on the change in internal jugular vein ultrasound-based indices. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Preeclampsia
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to Sep 2026
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients admitted at obstetric theater in Tanta University Hospital
Who may be able to join
- Singleton parturients from 18 to 40 years old.
- Either normotensive or preeclamptic parturients scheduled for elective cesarean section under neuro-axial block matched for gestational age 28-40 weeks will be included:
- Normotensive group: uncomplicated normotensive pregnancy with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90mmHg without proteinuria.
- Preeclamptic Group: new onset preeclamptic pregnant female with gestational hypertension after 20 weeks of pregnancy diagnosed based on ISSHP Guidelines: systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg, accompanied by one or more of the following:
- Proteinuria (≥300 mg in a 24-hour urine sample)
- Alb/Cr ratio ≥30 mg/mmol,
- Organ dysfunction (renal insufficiency (creatinine level>1.1mg%), liver involvement (liver enzyme levels ≥3 times normal), neurological complications (Headache and blurring of vision) and hematological involvement (thrombocytopenia<100.000)).
Who cannot join
- Parturients with pre-existing cardiac \& vascular disease affecting blood volume and vascular compliance: (Valvular or congenital heart disease, arrhythmia, previous history of venous thromboembolism, chronic kidney disease, gestational diabetes).
- multiple gestations
- known thyroid disorders or chronic hypertension
- patients with BMI >40 and patients requiring emergency delivery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, El-Gharbia Govenorate, 31527
Hospital
U
About this study
Official title: Internal Jugular Vein Collapsibility Index for Volume Status Assessment in Preeclampsia in Correlation With Normotensive Parturients: a Prospective Observational Cohort Study
This study aims to assess and analyze volume status in preeclamptic patients and compare these parameters with those of normotensive pregnant ones based on the change in internal jugular vein ultrasound-based indices.
Read the detailed description
Preeclampsia is a hypertensive disorder of pregnancy that remains a leading cause of maternal and perinatal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is characterized by endothelial dysfunction, increased vascular resistance, and fluid imbalance, all of which complicate perioperative management during cesarean delivery. Accurate assessment of intravascular volume status in these patients is critical for guiding fluid therapy, preventing hypovolemia that worsens uteroplacental perfusion, and avoiding fluid overload, which increases the risk of pulmonary edema - a major cause of maternal mortality in severe preeclampsia.
Traditionally, invasive methods such as central venous pressure (CVP) monitoring and pulmonary artery catheterization have been used to estimate intravascular volume and preload. However, these techniques are associated with significant risks, including infection, thrombosis, and procedural complications, making them unsuitable for routine use in obstetric patients. Non-invasive approaches, such as echocardiography and inferior vena cava (IVC) ultrasound, have been explored but have important limitations in preeclamptic parturients due to altered venous compliance, increased intra-abdominal pressure from gravid uterus, and technical challenges in obtaining consistent IVC windows.
Ultrasound assessment of the internal jugular vein (IJV) has emerged as a simple, rapid, and non-invasive and reproducible bedside technique for evaluating intravascular volume status. The IJV reflects central venous dynamics and can provide real-time information on venous collapsibility without the limitations posed by abdominal compression or operator dependency observed with IVC evaluation.
Importantly, preliminary data from previous study demonstrated that preoperative internal Jugular Vein collapsibility index strongly correlated with fluid status of the pregnant females undergoing cesarean section under spinal anesthesia.
Despite its potential, limited data exist regarding the use of IJV-based indices in preeclamptic parturients, the investigators hypothesize that IJV collapsibility index is a reliable marker of volume status and predictor of post-spinal hypotension in pre-eclamptic parturients , where vascular tone and compliance are significantly altered. This study aims to bridge this gap by assessing the internal jugular vein collapsibility index in pre-eclamptic parturients and comparing it with normotensive pregnant women to determine its clinical utility for optimizing perioperative fluid management.
The investigators hypothesize that this study helps to assess intravascular volume of preeclamptic Parturients to avoid hypovolemia or fluid overload which carry serious risk in this type of patients, both of which carry serious risks in this group of patients.
- Conditions
- Pre-Eclampsia, Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preeclamptic Group | Parturients diagnosed with preeclampsia diagnosed according to established diagnostic criteria of ISSHP: Pregnant female in the third trimester (after 20 weeks of pregnancy). | |
| Control Group | Normotensive Parturients matched for gestational age at the time of Ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring internal jugular vein (IJV) collapsibility index
Measuring internal jugular vein (IJV) collapsibility index at end expiratory phase just before the induction of anesthesia and its correlation with normotensive parturients to determine the cut off value of fluid status in preeclamptic patient
Measured: Intra-operative
Secondary outcomes (2)
Association between internal jugular vein ultrasound-based indices and severity of Preeclampsia.
Measured: Intra-operative
Value of internal Jugular vein collapsibility index in predicting post spinal hypotension
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelghany abdelhamed abdelghany Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786246
- Sponsor's protocol ID
- 36264MS101010/10/25
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Collapsibility Index for Volume Status Assessment in Preeclampsia in Correlation With Normotensive Parturients: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07786246
- Acronym / sponsor ID
- 36264MS101010/10/25
- Conditions
- Pre-Eclampsia, Preeclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Aug 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.
This study aims to assess and analyze volume status in preeclamptic patients and compare these parameters with those of normotensive pregnant ones based on the change in internal jugular vein ultrasound-based indices.
Detailed description
Preeclampsia is a hypertensive disorder of pregnancy that remains a leading cause of maternal and perinatal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is characterized by endothelial dysfunction, increased vascular resistance, and fluid imbalance, all of which complicate perioperative management during cesarean delivery. Accurate assessment of intravascular volume status in these patients is critical for guiding fluid therapy, preventing hypovolemia that worsens uteroplacental perfusion, and avoiding fluid overload, which increases the risk of pulmonary edema - a major cause of maternal mortality in severe preeclampsia.
Traditionally, invasive methods such as central venous pressure (CVP) monitoring and pulmonary artery catheterization have been used to estimate intravascular volume and preload. However, these techniques are associated with significant risks, including infection, thrombosis, and procedural complications, making them unsuitable for routine use in obstetric patients. Non-invasive approaches, such as echocardiography and inferior vena cava (IVC) ultrasound, have been explored but have important limitations in preeclamptic parturients due to altered venous compliance, increased intra-abdominal pressure from gravid uterus, and technical challenges in obtaining consistent IVC windows.
Ultrasound assessment of the internal jugular vein (IJV) has emerged as a simple, rapid, and non-invasive and reproducible bedside technique for evaluating intravascular volume status. The IJV reflects central venous dynamics and can provide real-time information on venous collapsibility without the limitations posed by abdominal compression or operator dependency observed with IVC evaluation.
Importantly, preliminary data from previous study demonstrated that preoperative internal Jugular Vein collapsibility index strongly correlated with fluid status of the pregnant females undergoing cesarean section under spinal anesthesia.
Despite its potential, limited data exist regarding the use of IJV-based indices in preeclamptic parturients, the investigators hypothesize that IJV collapsibility index is a reliable marker of volume status and predictor of post-spinal hypotension in pre-eclamptic parturients , where vascular tone and compliance are significantly altered. This study aims to bridge this gap by assessing the internal jugular vein collapsibility index in pre-eclamptic parturients and comparing it with normotensive pregnant women to determine its clinical utility for optimizing perioperative fluid management.
The investigators hypothesize that this study helps to assess intravascular volume of preeclamptic Parturients to avoid hypovolemia or fluid overload which carry serious risk in this type of patients, both of which carry serious risks in this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclamptic Group | – | –Parturients diagnosed with preeclampsia diagnosed according to established diagnostic criteria of ISSHP: Pregnant female in the third trimester (after 20 weeks of pregnancy). |
| Control Group | – | –Normotensive Parturients matched for gestational age at the time of Ultrasound. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients admitted at obstetric theater in Tanta University Hospital
Key inclusion criteria (7 listed)
- Singleton parturients from 18 to 40 years old.
- Either normotensive or preeclamptic parturients scheduled for elective cesarean section under neuro-axial block matched for gestational age 28-40 weeks will be included:
- Normotensive group: uncomplicated normotensive pregnancy with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90mmHg without proteinuria.
- Preeclamptic Group: new onset preeclamptic pregnant female with gestational hypertension after 20 weeks of pregnancy diagnosed based on ISSHP Guidelines: systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg, accompanied by one or more of the following:
Key exclusion criteria (4 listed)
- Parturients with pre-existing cardiac \& vascular disease affecting blood volume and vascular compliance: (Valvular or congenital heart disease, arrhythmia, previous history of venous thromboembolism, chronic kidney disease, gestational diabetes).
- multiple gestations
- known thyroid disorders or chronic hypertension
- patients with BMI >40 and patients requiring emergency delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring internal jugular vein (IJV) collapsibility index
Time frame: Intra-operative
Measuring internal jugular vein (IJV) collapsibility index at end expiratory phase just before the induction of anesthesia and its correlation with normotensive parturients to determine the cut off value of fluid status in preeclamptic patient
2 secondary outcomes
Association between internal jugular vein ultrasound-based indices and severity of Preeclampsia.
Time frame: Intra-operative
Value of internal Jugular vein collapsibility index in predicting post spinal hypotension
Time frame: Intra-operative
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia and Preeclampsia, run by Tanta 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 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.
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?
Contact Abdelghany AA Mohamed, MBBCH (+201123676274, Aldomiaty97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring internal jugular vein (IJV) collapsibility index (time frame: Intra-operative). 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 10 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.