Severe Pre-eclampsiaNCT05176652
Ultrasonographic Diameter of Optic Nerve Sheath in Fluid Assessment in Severe Preeclamptic Patients
An observational study of Severe Pre-eclampsia, run by Sohag University at 3 sites in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Severe Pre-eclampsia
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesEgypt
- Study dates
- 6 Dec 2021to 6 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Study population: severe preeclamptic patients (aged 18-40) after termination of pregnancy
Who may be able to join
- 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
Who cannot join
- patient refusal to participate in the study
- chronic kidney disease
- chronic pulmonary disease
- chronic cardiac disease
- chronic hypertension
- previous ocular operation and diseases
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Hossam Eldin Hassan Ahmed Abdelghani
Sohag, 82511
Hossam Eldin Hassan Ahmed, assistant lecturer, 01000393835, hossamhassan01000393835@gmail.com
- Recruiting
Hossam Eldin Hassan Ahmed Abdelghani
Sohag
hossam eldin hassan ahmed, assistant lecturer, 01000393835, hossamhassan01000393835@gmail.com
- Recruiting
Hossam Eldin Hassan Ahmed Abdelghani
Sohag
About this study
Official title: Reliability of Utrasonographic Diameter of Optic Nerve Sheath in Assessment of Fluid Status in Severe Preeclamptic Patients
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.
- Conditions
- Severe Pre-eclampsia
- Being tested
- ultrasound
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundRadiation
ultrasonographic assessment of optic nerve sheath diameter
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between optic nerve sheath diameter and extravascular lung water
correlation between ultrasound assessment of optic nerve sheath diameter and extravascular lung water
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start6 Dec 2021
- Primary completion6 Oct 2022 (estimated)
- Study completion6 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Eldin Hassan Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176652
- Sponsor's protocol ID
- Soh-Med-21-12-21
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Utrasonographic Diameter of Optic Nerve Sheath in Assessment of Fluid Status in Severe Preeclamptic Patients
- ClinicalTrials.gov ID
- NCT05176652
- Acronym / sponsor ID
- Soh-Med-21-12-21
- Conditions
- Severe Pre-eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Oct 2022 (estimated)
- Study completion
- 6 Dec 2022 (estimated)
- First posted
- 4 Jan 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- severe preeclamptic patients (aged 18-40) after termination of pregnancy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- patient refusal to participate in the study
- chronic kidney disease
- chronic pulmonary disease
- chronic cardiac disease
- chronic hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundultrasonographic assessment of optic nerve sheath diameter | Radiation | – |
Primary outcome
correlation between optic nerve sheath diameter and extravascular lung water
Time frame: up to 24 hours
correlation between ultrasound assessment of optic nerve sheath diameter and extravascular lung water
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Pre-eclampsia, run by Sohag University at 3 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam Eldin Hassan ahmed, assisstant lecturer (01000393835, hossamhassan01000393835@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between optic nerve sheath diameter and extravascular lung water (time frame: up to 24 hours). 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 4 Jan 2022.