AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

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

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.

Abdelghany AA Mohamed, MBBCH contact

+201123676274

Aldomiaty97@gmail.com

Egypt1 site, 1 recruiting
  • Tanta University Hospital

    Tanta, El-Gharbia Govenorate, 31527

    Hospital

    U

    Recruiting

Other trials in Egypt

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.

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 groups in NCT07786246
Study groupRoleWhat they receive
Preeclamptic GroupParturients diagnosed with preeclampsia diagnosed according to established diagnostic criteria of ISSHP: Pregnant female in the third trimester (after 20 weeks of pregnancy).
Control GroupNormotensive 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.

  1. 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)
  1. Association between internal jugular vein ultrasound-based indices and severity of Preeclampsia.

    Measured: Intra-operative

  2. 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.

  1. First posted25 Aug 2026
  2. Study start1 Oct 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in