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

NCT06122220 | Recruiting

• 1 other identifier: FA012023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Keywords

Angiogenic factors; Optic nerve sheath diameter; Pre-eclampsia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Maternal/fetal morbidity

  Up until discharge. On average, 7 days

• Neonatal morbidity

  Up until discharge. On average, 3 days

Study Arms (2)

Pre-eclampsia

EXPERIMENTAL

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

Procedure: ONSD+AF

Control

ACTIVE COMPARATOR

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

Procedure: ONSD+AF

Interventions

ONSD+AF PROCEDURE

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

Control; Pre-eclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women between 24 and 40 weeks of gestation.

You may not qualify if:

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

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Osvaldo Reyes, MD

CONTACT

+507 65655041; oreyespanama@yahoo.es

Adriana Martinz, MD

CONTACT

amartinzmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the research deparment

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: August 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)