Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-29 @ 6:04 PM
Study NCT ID:
NCT06325735
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2024-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Systemic Inflammatory Indices and Birth Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic inflammatory indices and birth weight', 'timeFrame': '3 months', 'description': 'investigate the correlation between systemic inflammatory indices and birth weight in full-term pregnancies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Inflammation Markers', 'Birth Weight', 'Combined Systemic Inflammatory Indices']}, 'descriptionModule': {'briefSummary': 'The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight', 'detailedDescription': 'The research was structured as a prospective observational study. It was conducted at a second-level University Hospital over the period from December 2019 to February 2021.\n\nParticipants:\n\nBlood samples were collected at hospital admission. These samples were used for a complete blood count, focusing specifically on deriving systemic inflammatory indices.\n\nThe primary inflammatory indices studied were Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR).\n\nThe birth weight was registered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population comprised full-term pregnant women. These participants were likely to represent a diverse range of ages and backgrounds, typical of a general pregnant population at a second-level University Hospital.\n\nHealth Status: The women included were in generally good health, with full-term, uncomplicated pregnancies. This was ensured by the rigorous exclusion of any pregnancies affected by significant health issues such as diabetes, hypertension, and other specified conditions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physiological Full-term pregnancies\n\nExclusion Criteria:\n\n* gestational diabetes\n* pregestational diabetes\n* Chronic Hypertension\n* Gestational Hypertension\n* Preeclampsia\n* Eclampsia\n* Intrauterine Fetal Growth Restriction\n* Preterm Delivery\n* Multiple Pregnancies\n* Fetal malformations'}, 'identificationModule': {'nctId': 'NCT06325735', 'briefTitle': 'Combined Systemic Inflammatory Indices and Birth Weight', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Combined Systemic Inflammatory Indices and Their Impact on Birth Weight: A Prospective Observational Study.', 'orgStudyIdInfo': {'id': '98'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'full term pregnancy', 'description': 'Total Participants: The study included full-term pregnant women.\n\nExclusion Criteria: Participants were carefully selected, excluding those with specific conditions that could confound the study results. These conditions included gestational and pregestational diabetes, chronic hypertension, gestational hypertension, pre-eclampsia/eclampsia, intrauterine fetal growth restriction, preterm delivery, multiple pregnancies, and prenatally detected fetal abnormalities.', 'interventionNames': ['Diagnostic Test: None intervention']}], 'interventions': [{'name': 'None intervention', 'type': 'DIAGNOSTIC_TEST', 'description': 'None intervention, observational study', 'armGroupLabels': ['full term pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Napoli', 'state': 'Italia', 'country': 'Italy', 'facility': 'Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Marco La Verde', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}