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

Not Applicable

Not yet recruiting

• Conditions: Pre-Eclampsia
• Interventions: Procedure: ONSD+AF

• Registration Number: NCT06122220
• Lead Sponsor: Saint Thomas Hospital, Panama

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-06
• Study Start: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	ONSD+AF	Subjects admitted for normal labor, without any criteria of pre-eclampsia
Pre-eclampsia	ONSD+AF	Subjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama