Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Optic nerve sheath diameter cut off value [Up to discharge. On average, 7 days.]
Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia
- sFLT-1/PiGF index [Up until discharge. On average, 7 days]
Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia
Secondary Outcome Measures
- Maternal/fetal morbidity [Up until discharge. On average, 7 days]
Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).
- Neonatal morbidity [Up until discharge. On average, 3 days]
Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Thomas H | Panama | Panama |
Sponsors and Collaborators
- Saint Thomas Hospital, Panama
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FA012023