Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-28 @ 4:36 AM
Study NCT ID:
NCT07093957
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Delivery Method on Umbilical Cord Metabolomic Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cord blood metabolome analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cord blood metabolomic analysis', 'timeFrame': 'From enrollment to birth. Cord Blood is taken during birth', 'description': 'Cord blood samples will be analysed via LC/MS analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cord blood', 'metabolomics'], 'conditions': ['Metabolomics', 'Cord Blood']}, 'referencesModule': {'references': [{'pmid': '39725908', 'type': 'BACKGROUND', 'citation': 'Huang Y, Ni Y, Meng Y, Zeng X, He X, Zhang L, Zhang J. Integrated proteomics and metabolomics network analysis across different delivery modes in human pregnancy: a pilot study. BMC Pregnancy Childbirth. 2024 Dec 26;24(1):868. doi: 10.1186/s12884-024-07097-4.'}, {'pmid': '31201538', 'type': 'BACKGROUND', 'citation': 'Shokry E, Marchioro L, Uhl O, Bermudez MG, Garcia-Santos JA, Segura MT, Campoy C, Koletzko B. Investigation of the impact of birth by cesarean section on fetal and maternal metabolism. Arch Gynecol Obstet. 2019 Sep;300(3):589-600. doi: 10.1007/s00404-019-05213-w. Epub 2019 Jun 14.'}, {'pmid': '33493154', 'type': 'BACKGROUND', 'citation': 'Ross AB, Barman M, Hartvigsson O, Lundell AC, Savolainen O, Hesselmar B, Wold AE, Sandberg AS. Umbilical cord blood metabolome differs in relation to delivery mode, birth order and sex, maternal diet and possibly future allergy development in rural children. PLoS One. 2021 Jan 25;16(1):e0242978. doi: 10.1371/journal.pone.0242978. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Birth type is closely linked to fetal and maternal stress responses. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level.', 'detailedDescription': 'Birth type is closely linked to fetal and maternal stress responses. Previous studies have found higher levels of hormones associated with stress responses in mothers who delivered vaginally compared to those who delivered by cesarean section (C/S). Similarly, differences in markers assessing stress responses in newborns have been observed based on delivery method. However, the literature lacks sufficient studies on low-molecular-weight metabolites, which reveal the metabolic status of newborns.\n\nMetabolomic profiling studies are introductory studies that provide comprehensive information about cell or organism metabolism. They contribute to research in many areas of medicine. In perinatology, metabolomic profiling studies have been conducted on topics such as neural tube defects, intrauterine growth restriction, and maternal diabetes. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population included pregnant women aged between 18 and 35 years who were regularly followed during their pregnancy and delivered at term. Women with a diagnosis of diabetes mellitus or hypertension either before or during pregnancy were excluded from the study. Additionally, pregnancies with multiple fetuses, non-elective cesarean sections, intrauterine growth restriction, or fetal congenital anomalies (or suspicion thereof) were not included. The study aimed to ensure a homogeneous and healthy sample to evaluate neonatal stress responses in relation to the mode of delivery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Female patient aged 18-35 2) Term pregnancy 3) Pregnant with follow-up\n\nExclusion Criteria:\n\n* 1\\) Having been diagnosed with diabetes mellitus before or during pregnancy 2) Having been diagnosed with hypertension before or during pregnancy 3) Non-singleton pregnancy 4) Non-elective C/S 5) Fetal intrauterine growth restriction 6) Mothers and their babies with a fetal birth anomaly or suspected birth anomaly will not be included in this study.'}, 'identificationModule': {'nctId': 'NCT07093957', 'briefTitle': 'Effect of Delivery Method on Umbilical Cord Metabolomic Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'Effect of Delivery Method on Umbilical Cord Metabolomic Analysis', 'orgStudyIdInfo': {'id': 'CORD_omics'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'C/S', 'description': 'Babies delivered via C/S'}, {'label': 'Vaginal', 'description': 'Babies delivered vaginally'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68110', 'city': 'Aksaray', 'country': 'Turkey (Türkiye)', 'facility': 'Aksaray University', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Ekin Guran, MD', 'investigatorAffiliation': 'Aksaray University Training and Research Hospital'}}}}