Pre-EclampsiaNCT06122220
Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.
A study testing ONSD+AF in people with Pre-Eclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- ONSD+AF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePanama
- Study dates
- 15 Aug 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women between 24 and 40 weeks of gestation.
Who cannot join
- Multiple gestation
- Maternal vasculitis
- Previous cesarean section (3 or more)
- Brain or eye tumors
- Neurological conditions
- Chronic renal disease
- Purpura
- Heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of 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.
- Conditions
- Pre-Eclampsia
- Being tested
- ONSD+AF
- Keywords
- Angiogenic factors, Optic nerve sheath diameter, Pre-eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSD+AFProcedure or surgery
Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index
| Study group | Role | What they receive |
|---|---|---|
| Pre-eclampsia | Experimental | Subjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG) Receives: Procedure: ONSD+AF |
| Control | Active comparator | Subjects admitted for normal labor, without any criteria of pre-eclampsia Receives: Procedure: ONSD+AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter cut off value
Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia
Measured: Up to discharge. On average, 7 days.
sFLT-1/PiGF index
Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia
Measured: Up until discharge. On average, 7 days
Secondary outcomes (2)
Maternal/fetal morbidity
Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).
Measured: Up until discharge. On average, 7 days
Neonatal morbidity
Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)
Measured: Up until discharge. On average, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start15 Aug 2025
- Primary completion31 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122220
- Sponsor's protocol ID
- FA012023
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of Pre-eclampsia
- ClinicalTrials.gov ID
- NCT06122220
- Acronym / sponsor ID
- FA012023
- Conditions
- Pre-Eclampsia
- Keywords
- Angiogenic factors, Optic nerve sheath diameter, Pre-eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-eclampsia | Experimental | Procedure: ONSD+AFSubjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG) |
| Control | Active comparator | Procedure: ONSD+AFSubjects admitted for normal labor, without any criteria of pre-eclampsia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women between 24 and 40 weeks of gestation.
Key exclusion criteria (8 listed)
- Multiple gestation
- Maternal vasculitis
- Previous cesarean section (3 or more)
- Brain or eye tumors
- Neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONSD+AFMeasurement of the optic nerve sheath diameter and of sFLT-1/PGIF index | Procedure or surgery | Control, Pre-eclampsia |
Primary outcome
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
2 secondary outcomes
Maternal/fetal morbidity
Time frame: Up until discharge. On average, 7 days
Neonatal morbidity
Time frame: Up until discharge. On average, 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONSD+AF in people with Pre-Eclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter cut off value (time frame: Up to discharge. On average, 7 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.