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

NCT ID: NCT06122220

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pre-eclampsia

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

Group Type EXPERIMENTAL

ONSD+AF

Intervention Type PROCEDURE

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

Control

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

Group Type ACTIVE_COMPARATOR

ONSD+AF

Intervention Type PROCEDURE

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

Interventions

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ONSD+AF

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Head of the research deparment

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Site Status RECRUITING

Countries

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Panama

Central Contacts

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Osvaldo Reyes, MD

Role: CONTACT

+507 65655041

Adriana Martinz, MD

Role: CONTACT

Facility Contacts

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Osvaldo A Reyes, MD

Role: primary

o11(507)65655041

Lisseth Rodriguez, MD

Role: backup

Other Identifiers

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FA012023

Identifier Type: -

Identifier Source: org_study_id

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