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

Study Overview
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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.

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

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Procedure: ONSD+AF


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-eclampsia<br>Subjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG) | Procedure: ONSD+AF<br>* Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index<br>|
| Active Comparator: Control<br>Subjects admitted for normal labor, without any criteria of pre-eclampsia | Procedure: ONSD+AF<br>* Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiogenic factors, Optic nerve sheath diameter, Pre-eclampsia