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

Saint Thomas Hospital (HST)

Status: Not yet enrolling

Conditions: Pre-Eclampsia

Treatments: Procedure: ONSD+AF

Study type: Interventional

Funder types: Other

Identifiers

NCT06122220

FA012023

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pre-eclampsia

Experimental group

Description:

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

Treatment:

Procedure: ONSD+AF

Control

Active Comparator group

Description:

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

Treatment:

Procedure: ONSD+AF