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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122220
• Other study ID #: FA012023
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Saint Thomas Hospital, Panama
• Contact: Osvaldo Reyes, MD
• Phone: +507 65655041
• Email: oreyespanama[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Procedure:
• ONSD+AF
Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	Neonatal morbidity	Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)	Up until discharge. On average, 3 days