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

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: Recruiting
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Procedure: ONSD+AF

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osvaldo Reyes, MD; Phone Number: +507 65655041; Email: oreyespanama@yahoo.es
• Study Contact Backup: Name: Adriana Martinz, MD; Email: amartinzmd@gmail.com

Study Locations

• Panama
  • Provincia de Panamá
    • Panama City, Provincia de Panamá, Panama
      • Recruiting
      • Saint Thomas Hospital
      • Contact: Osvaldo A Reyes, MD; Phone Number: o11(507)65655041; Email: oreyespanama@yahoo.es
      • Contact: Lisseth Rodriguez, MD; Email: lissyro29@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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

• Sponsor: Saint Thomas Hospital, Panama

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 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 (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Optic nerve sheath diameter; Pre-eclampsia; Angiogenic factors
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• 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