NCT05176652

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

December 6, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

December 14, 2021

Last Update Submit

January 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

ultrasoundRADIATION

ultrasonographic assessment of optic nerve sheath diameter

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant preeclamptic patients
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

severe preeclamptic patients (aged 18-40) after termination of pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • patient refusal to participate in the study
  • chronic kidney disease
  • chronic pulmonary disease
  • chronic cardiac disease
  • chronic hypertension
  • previous ocular operation and diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hossam Eldin Hassan Ahmed Abdelghani

Sohag, 82511, Egypt

RECRUITING

Hossam Eldin Hassan Ahmed Abdelghani

Sohag, Egypt

RECRUITING

Hossam Eldin Hassan Ahmed Abdelghani

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Hossam Eldin Hassan ahmed, assisstant lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer of anesthesia and ICU ,faculty of medicine at sohag university

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 4, 2022

Study Start

December 6, 2021

Primary Completion

October 6, 2022

Study Completion

December 6, 2022

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations