Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.
ConditionPre-Eclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSaint Thomas Hospital, Panama
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women between 24 and 40 weeks of gestation.
Disqualifiers
Multiple gestation
Maternal vasculitis
Previous cesarean section (3 or more)
Brain or eye tumors
Trial design
Design model
Parallel
Treatments tested in this trial
ONSD+AF
Procedure/SurgeryMeasurement of the optic nerve sheath diameter and of sFLT-1/PGIF index
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Pre-eclampsiaExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Optic nerve sheath diameter cut off value
Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia
Time frame
Up to discharge. On average, 7 days.2
sFLT-1/PiGF index
Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia
Time frame
Up until discharge. On average, 7 daysSecondary outcomes
1
Maternal/fetal morbidity
Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).
Time frame
Up until discharge. On average, 7 days2
Neonatal morbidity
Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)
Time frame
Up until discharge. On average, 3 daysSponsors and contacts
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Source ClinicalTrials.gov