Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-28 @ 5:04 PM
Study NCT ID:
NCT06166303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Number of Previous Cesarean Sections on the Results of Angiogenic Factors.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Index sFlt-1/PIGF', 'timeFrame': 'From the moment of randomization up until delivery. Between 24-48 hours.', 'description': 'Angiogenic factors, normal value.'}], 'secondaryOutcomes': [{'measure': 'Progression to preeclampsia', 'timeFrame': 'Up until discharge. On average, 7 days', 'description': 'Number of subjects that develop a preeclampsia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean section', 'Angiogenic factors', 'Preeclampsia'], 'conditions': ['Cesarean Section']}, '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.\n\nAlthough the usefulness of angiogenic factors in these scenarios is known, little is known about the effects that other conditions might have on their serum levels, mainly those that have an effect on trophoblastic invasion, the process that initiates implantation of the pregnancy in the endometrium. The purpose of the present study is to assess the effect that a history of uterine surgery, such as caesarean section, might have on angiogenic factor scores in subjects with no history of a hypertensive disorder of pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant woman with a previous cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 36 weeks of gestation or more\n* Singleton pregnancy\n* Previous cesarean section (case)\n\nExclusion Criteria:\n\n* Vasculitis\n* Twin pregnancy\n* Chronic endometritis\n* Smoking\n* Lupus\n* Renal failure\n* Liver disease\n* Thrombocytopenia'}, 'identificationModule': {'nctId': 'NCT06166303', 'briefTitle': 'Number of Previous Cesarean Sections on the Results of Angiogenic Factors.', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Effect of Number of Previous Cesarean Sections on the Results of Angiogenic Factors. A Descriptive, Prospective Study.', 'orgStudyIdInfo': {'id': 'U1111-1301-2580'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Previous Cesarean Section', 'description': 'Subjects with one or more previous cesarean sections', 'interventionNames': ['Diagnostic Test: sFlt-1/PGIF']}, {'label': 'No Cesarean', 'description': 'Subjects scheduled for an elective or urgent cesarean, but no history of previous cesarean section', 'interventionNames': ['Diagnostic Test: sFlt-1/PGIF']}], 'interventions': [{'name': 'sFlt-1/PGIF', 'type': 'DIAGNOSTIC_TEST', 'description': 'Index of sFlt-1/PGIF', 'armGroupLabels': ['No Cesarean', 'Previous Cesarean Section']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas H', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Osvaldo Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es', 'phone': '+507 65655041'}], 'overallOfficials': [{'name': 'Osvaldo Reyes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Santo Tomás'}]}, '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'}}}}