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CompletedNCT06122220Updated Jul 16, 2026

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

An interventional study of ONSD+AF in Pre-Eclampsia, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Pre-Eclampsia

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Keywords

  • Angiogenic factors
  • Optic nerve sheath diameter
  • Pre-eclampsia
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's enrollment of 200 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women between 24 and 40 weeks of gestation.

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Pre-eclampsia

    Subjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG)

    Procedure: ONSD+AF

  • Active comparator
    Control

    Subjects admitted for normal labor, without any criteria of pre-eclampsia

    Procedure: ONSD+AF

Interventions

  • ProcedureONSD+AF

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

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What researchers measure

Primary outcomes

  1. Optic nerve sheath diameter cut off value

    Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia

    Time frame: Up to discharge. On average, 7 days.

  2. sFLT-1/PiGF index

    Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia

    Time frame: Up until discharge. On average, 7 days

Secondary outcomes

  1. Maternal/fetal morbidity

    Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).

    Time frame: Up until discharge. On average, 7 days

  2. Neonatal morbidity

    Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)

    Time frame: Up until discharge. On average, 3 days

07

Study locations

1 site
  • Saint Thomas Hospital
    Panama City, Provincia de Panamá, Panama
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06122220
Lead sponsor
Saint Thomas Hospital, Panama
Responsible party
Osvaldo A. Reyes T. (Head of the research deparment, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Nov 8, 2023
Start date
Aug 15, 2025
Primary completion
Mar 31, 2026
Completion
May 30, 2026
Last update
Jul 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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