NCT07786246

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Outcome Measures

Primary Outcomes (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

    Intra-operative

Secondary Outcomes (2)

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

    Intra-operative

  • Value of internal Jugular vein collapsibility index in predicting post spinal hypotension

    Intra-operative

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients admitted at obstetric theater in Tanta University Hospital

You may qualify if:

  • 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)).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia Govenorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Abdelghany AA Mohamed, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesia, Surgical Intensive Care and Pain Management

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year

Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations