Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06122220
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve sheath diameter cut off value', 'timeFrame': 'Up to discharge. On average, 7 days.', 'description': 'Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia'}, {'measure': 'sFLT-1/PiGF index', 'timeFrame': 'Up until discharge. On average, 7 days', 'description': 'Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia'}], 'secondaryOutcomes': [{'measure': 'Maternal/fetal morbidity', 'timeFrame': 'Up until discharge. On average, 7 days', 'description': 'Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).'}, {'measure': 'Neonatal morbidity', 'timeFrame': 'Up until discharge. On average, 3 days', 'description': 'Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalophatic hypoxia)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Angiogenic factors', 'Optic nerve sheath diameter', 'Pre-eclampsia'], 'conditions': ['Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 24 and 40 weeks of gestation.\n\nExclusion Criteria:\n\n* Multiple gestation\n* Maternal vasculitis\n* Previous cesarean section (3 or more)\n* Brain or eye tumors\n* Neurological conditions\n* Chronic renal disease\n* Purpura\n* Heart disease'}, 'identificationModule': {'nctId': 'NCT06122220', 'briefTitle': 'Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of Pre-eclampsia', 'orgStudyIdInfo': {'id': 'FA012023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-eclampsia', 'description': 'Subjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG)', 'interventionNames': ['Procedure: ONSD+AF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Subjects admitted for normal labor, without any criteria of pre-eclampsia', 'interventionNames': ['Procedure: ONSD+AF']}], 'interventions': [{'name': 'ONSD+AF', 'type': 'PROCEDURE', 'description': 'Measurement of the optic nerve sheath diameter and of sFLT-1/PGIF index', 'armGroupLabels': ['Control', 'Pre-eclampsia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'status': 'RECRUITING', 'country': 'Panama', 'contacts': [{'name': 'Osvaldo A Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es', 'phone': 'o11(507)65655041'}, {'name': 'Lisseth Rodriguez, MD', 'role': 'CONTACT', 'email': 'lissyro29@gmail.com'}], 'facility': 'Saint Thomas Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Osvaldo Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es', 'phone': '+507 65655041'}, {'name': 'Adriana Martinz, MD', 'role': 'CONTACT', 'email': 'amartinzmd@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the research deparment', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}