Ultrasonographic Diameter of Optic Nerve Sheath in Fluid Assessment in Severe Preeclamptic Patients

Severe Pre-eclampsia Clinical Trial

Official title:

Reliability of Utrasonographic Diameter of Optic Nerve Sheath in Assessment of Fluid Status in Severe Preeclamptic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176652
• Other study ID #: Soh-Med-21-12-21
• Status: Recruiting
• Start date: December 6, 2021
• Est. completion date: December 6, 2022

Study information

• Verified date: December 2021
• Source: Sohag University
• Contact: Hossam Eldin Hassan ahmed, assisstant lecturer
• Phone: 01000393835
• Email: hossamhassan01000393835[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Changes in the optic nerve sheath diameter detected by ultrasound are considered an important manifestation of increased intracranial pressure . The normal optic nerve sheath diameter measures up to 5.0 mm and an average optic nerve sheath diameter more than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.Cerebral edema have been demonstrated in 71% to 100% of magnetic resonance imaging in preeclamptic patients and an increase in optic nerve sheath diameter has been described in preeclamptic females compared to healthy pregnant females Therefore, Increased optic nerve sheath diameter can indirectly reflect the state of intracranial edema that could be a part of generalized edema of preeclampsia and it could be a possible marker of generalized tissue edema and fluid overload in these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Systolic blood pressure of 160mm Hg or higher, or diastolic blood pressure of 110mm Hg or higher on 2 occasions at least 6 hours apart on bed rest.

• Proteinuria =5g in a 24 hour urine specimen or =3+ on 2 random urine samples collected at least 4 hours apart.

• patient acceptance

• Accepted mental state of the patients

Exclusion Criteria:

• patient refusal to participate in the study

• chronic kidney disease

• chronic pulmonary disease

• chronic cardiac disease

• chronic hypertension

• previous ocular operation and diseases

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Severe Pre-eclampsia

Intervention

Radiation:
• ultrasound
ultrasonographic assessment of optic nerve sheath diameter

Locations

Country	Name	City	State
Egypt	Hossam Eldin Hassan Ahmed Abdelghani	Sohag
Egypt	Hossam Eldin Hassan Ahmed Abdelghani	Sohag
Egypt	Hossam Eldin Hassan Ahmed Abdelghani	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between optic nerve sheath diameter and extravascular lung water	correlation between ultrasound assessment of optic nerve sheath diameter and extravascular lung water	up to 24 hours