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

July 14, 2026 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama
        • Saint Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index
Active Comparator: Control
Subjects admitted for normal labor, without any criteria of pre-eclampsia
Procedure: ONSD+AF
Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter cut off value
Time Frame: Up to discharge. On average, 7 days.
Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia
Up to discharge. On average, 7 days.
sFLT-1/PiGF index
Time Frame: Up until discharge. On average, 7 days
Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia
Up until discharge. On average, 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal/fetal morbidity
Time Frame: Up until discharge. On average, 7 days
Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).
Up until discharge. On average, 7 days
Neonatal morbidity
Time Frame: Up until discharge. On average, 3 days
Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)
Up until discharge. On average, 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

May 30, 2026

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA012023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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