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Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.

Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of Pre-eclampsia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06122220
Enrollment
200
Registered
2023-11-08
Start date
2025-08-15
Completion date
2026-05-30
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

Angiogenic factors, Optic nerve sheath diameter, Pre-eclampsia

Brief summary

Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. Refining the diagnostic capability of this test would further improve maternal-fetal outcomes and the use of optic nerve sheath diameter (ONSD) measurement could make the difference. The purpose of the present study is to correlate the measurement of ONSD with serum angiogenic factor (AF) values in patients with pre-eclampsia and to determine its predictive ability for adverse perinatal outcomes.

Interventions

PROCEDUREONSD+AF

Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index

Sponsors

Saint Thomas Hospital, Panama
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women between 24 and 40 weeks of gestation.

Exclusion criteria

* Multiple gestation * Maternal vasculitis * Previous cesarean section (3 or more) * Brain or eye tumors * Neurological conditions * Chronic renal disease * Purpura * Heart disease

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter cut off valueUp to discharge. On average, 7 days.Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia
sFLT-1/PiGF indexUp until discharge. On average, 7 daysValue of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia

Secondary

MeasureTime frameDescription
Maternal/fetal morbidityUp until discharge. On average, 7 daysPresence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).
Neonatal morbidityUp until discharge. On average, 3 daysPresence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026