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NCT Number: NCT06122220

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

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONSD+AF

Procedure

Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index

Primary outcomes

  1. 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

  2. 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

  1. Maternal/fetal morbidity

    Time frame: 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).

  2. Neonatal morbidity

    Time frame: Up until discharge. On average, 3 days

    Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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