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PreeclampsiaNCT06522295

Assessment of Optic Nerve Sheath Diameter in Preeclamptic Pregnant Women Using Ultrasonography and Anesthetic Management

An observational study of Preeclampsia and Intracranial Pressure Increase, run by Kocaeli University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Preeclampsia is a serious condition associated with complications such as pulmonary edema, placental abruption, hemolysis, thrombocytopenia, and cardiac, renal, and neurological complications, occurring at a rate of 2.7-8% in pregnant women (1,2). Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
ultrasonography
Type of treatment
Medical device
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Sep 2024to 30 Jun 2025
How long will I take part?
3 Days
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: pregnant womens with mild and severe preeclampsia

Who may be able to join

  • asa 2-3 Individuals Aged 18 and Above Individuals with Gestational Age of 37 Weeks and Above pregnancy with health, mild preeclampsia, severe preeclampsia

Who cannot join

  • Multiple pregnancies Fetal anomalies Patients with contraindications to ocular ultrasound (allergy to ultrasound gel, ocular injury or infection, facial fracture) Conditions known to increase cerebral pressure (idiopathic intracranial hypertension, brain tumor, recent history of brain trauma) Conditions potentially leading to edema (heart failure, glomerulonephritis or nephrotic syndrome, liver failure, malnutrition, hypothyroidism) Ophthalmic conditions that may affect optic nerve sheath diameter measurement (glaucoma, cataracts, previous eye surgery) Chronic hypertension

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kocaeli University

    Kocaeli

Other trials in Turkey (Türkiye)

About this study

Preeclampsia is a serious condition associated with complications such as pulmonary edema, placental abruption, hemolysis, thrombocytopenia, and cardiac, renal, and neurological complications, occurring at a rate of 2.7-8% in pregnant women (1,2). Neurological complications are believed to be associated with reversible cerebral vasoconstriction syndrome (3,4) and/or posterior leukoencephalopathy syndrome (4,5,6), sharing a common pathophysiology. Cerebral edema is primarily vasogenic, potentially linked to hyperperfusion resulting from impaired cerebral autoregulation, blood-brain barrier disruption, and endothelial cell dysfunction. In some eclampsia cases, computed tomography and magnetic resonance imaging may reveal signs consistent with significantly increased intracranial pressure (ICP) (7). However, the true incidence of elevated ICP in preeclampsia is unknown, clinical symptoms are nonspecific, and interpretation, especially during pregnancy and preeclampsia, can be challenging (2).

Cesarean section, currently one of the most frequently performed surgeries worldwide, is conducted in 21.1% of women (8). Anesthesia for cesarean section can be divided into neuraxial and general anesthesia. The choice of anesthesia technique in conditions that may increase intracranial pressure, such as cerebral edema, may vary based on balancing risks and benefits. Neuraxial analgesia and anesthesia are the first choice in healthy pregnancies, but may be contraindicated in cases with intracranial lesions or increased bleeding risk (9). The presence of focal neurological deficits may favor general anesthesia for cesarean delivery (10). General anesthesia in these patients may result in an increased hemodynamic response to laryngoscopy. Agents used in induction and maintenance can also affect cerebral autoregulation (11). Anesthesia induction and maintenance for these patients should be planned to minimize the increase in intracranial pressure.

Read more

The optic nerve, a part of the central nervous system, is surrounded by a dural sheath and a subarachnoid space containing cerebrospinal fluid. Three millimeters behind the ocular globe, the optic nerve is solely surrounded by fat, and the dural sheath can retract within its fatty environment, particularly in conditions of increased pressure in the cerebrospinal fluid (2). Recent clinical studies have reported that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) are correlated with increased intracranial pressure symptoms and may serve as a non-invasive reliable indicator of ICP (12,13). Studies have reported high inter-observer reliability for ONSD measurements (14,15). ONSD measurement is easy, repeatable at the bedside, rapid, inexpensive, and does not involve radiation.

Compared to healthy pregnant women, preeclamptic women are considered to have higher intracranial pressure during the childbirth process. Anesthetic management for delivery in these women can be complex and controversial. The aim of this study is to evaluate ultrasonographic measurements of optic nerve sheath diameter during the perioperative period, independent of anesthesia management, in healthy and preeclamptic pregnant women undergoing cesarean section. We believe that these assessments will contribute to more reliable anesthesia planning for preeclamptic pregnancies.

Being tested
ultrasonography
Medical subject headings
Pre-Eclampsia, Intracranial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasonographyDevice

    Ultrasonographic Measurement of Optic Nerve Sheath Diameter

Study groups in NCT06522295
Study groupRoleWhat they receive
preeclampsiaNot described
Receives: Device: ultrasonography
severe preeclampsiaNot described
Receives: Device: ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Difference in Optic Nerve Sheath Diameter Between Severe and Mild Preeclampsia

    Measured: 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start22 Sep 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (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
38 participants (estimated)
Target duration
3 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522295
Sponsor's protocol ID
POSK23
Status last verified
Jul 2024
First submitted
22 Jul 2024
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.

    PubMed 22258019
  • Hinchey J, Chaves C, Appignani B, Breen J, Pao L, Wang A, Pessin MS, Lamy C, Mas JL, Caplan LR. A reversible posterior leukoencephalopathy syndrome. N Engl J Med. 1996 Feb 22;334(8):494-500. doi: 10.1056/NEJM199602223340803.

    PubMed 8559202
  • Anson JA, Vaida S, Giampetro DM, McQuillan PM. Anesthetic management of labor and delivery in patients with elevated intracranial pressure. Int J Obstet Anesth. 2015 May;24(2):147-60. doi: 10.1016/j.ijoa.2015.01.004. Epub 2015 Jan 19.

    PubMed 25794413
  • Finfer SR. Management of labour and delivery in patients with intracranial neoplasms. Br J Anaesth. 1991 Dec;67(6):784-7. doi: 10.1093/bja/67.6.784.

    PubMed 1768551

Questions about this trial

What is this clinical trial studying?

An observational study of Preeclampsia and Intracranial Pressure Increase, run by Kocaeli University at 1 site in Turkey (Türkiye).

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 1 inclusion and 1 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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 tülay sahin (+905322825454, tulaydogac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Difference in Optic Nerve Sheath Diameter Between Severe and Mild Preeclampsia (time frame: 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522295, which also lists 4 linked publications.

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 26 Jul 2024.

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