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Clinical Trials/NCT06122220
NCT06122220
Recruiting
Not Applicable

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

Saint Thomas Hospital, Panama1 site in 1 country200 target enrollmentAugust 15, 2025
ConditionsPre-Eclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Eclampsia
Sponsor
Saint Thomas Hospital, Panama
Enrollment
200
Locations
1
Primary Endpoint
Optic nerve sheath diameter cut off value
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2025
End Date
January 30, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Saint Thomas Hospital, Panama
Responsible Party
Principal Investigator
Principal Investigator

Osvaldo A. Reyes T.

Head of the research deparment

Saint Thomas Hospital, Panama

Eligibility 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
  • Heart disease

Outcomes

Primary Outcomes

Optic nerve sheath diameter cut off value

Time Frame: 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

Time Frame: 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 Outcomes

  • Maternal/fetal morbidity(Up until discharge. On average, 7 days)
  • Neonatal morbidity(Up until discharge. On average, 3 days)

Study Sites (1)

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