Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT03761966
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2018-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytokines Profile at the Beginning of Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokines levels', 'timeFrame': '2017-2018', 'description': 'The expression levels of IL-10, IL-4, IFN-γ and TNF-α will be performed by the ELISA technique on an ELx800 ™ device (BioTek Instruments, Inc.) at the Research Laboratory of Ciprés Grupo Médico S.C. (CGM).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IL-10', 'IL-4', 'IFN-γ', 'TNF-α', 'Pregnancy'], 'conditions': ['Correlation of Cytokines and Anthropometry in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23997222', 'type': 'BACKGROUND', 'citation': 'Lombardelli L, Aguerre-Girr M, Logiodice F, Kullolli O, Casart Y, Polgar B, Berrebi A, Romagnani S, Maggi E, Le Bouteiller P, Piccinni MP. HLA-G5 induces IL-4 secretion critical for successful pregnancy through differential expression of ILT2 receptor on decidual CD4(+) T cells and macrophages. J Immunol. 2013 Oct 1;191(7):3651-62. doi: 10.4049/jimmunol.1300567. Epub 2013 Aug 30.'}, {'pmid': '25269386', 'type': 'BACKGROUND', 'citation': 'Cheng SB, Sharma S. Interleukin-10: a pleiotropic regulator in pregnancy. Am J Reprod Immunol. 2015 Jun;73(6):487-500. doi: 10.1111/aji.12329. Epub 2014 Oct 1.'}, {'pmid': '23484206', 'type': 'BACKGROUND', 'citation': 'Ziganshina MM, Krechetova LV, Vanko LV, Nikolaeva MA, Khodzhaeva ZS, Sukhikh GT. Time course of the cytokine profiles during the early period of normal pregnancy and in patients with a history of habitual miscarriage. Bull Exp Biol Med. 2013 Jan;154(3):385-7. doi: 10.1007/s10517-013-1956-0.'}, {'pmid': '8363725', 'type': 'BACKGROUND', 'citation': 'Wegmann TG, Lin H, Guilbert L, Mosmann TR. Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon? Immunol Today. 1993 Jul;14(7):353-6. doi: 10.1016/0167-5699(93)90235-D.'}]}, 'descriptionModule': {'briefSummary': 'A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the aim was to determine if there is some association between the weight changes in pregnancy and the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha (TNF-α).', 'detailedDescription': "Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent. Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.\n\nWeight and height were measured using a calibrated using an adult scale (Seca, Hamburg, Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written nutritional guidance depending on the characteristics of each patient.\n\nThe expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.\n\nQuantitative variables will be represented by measures of central tendency. Once the Kolmogorov test is performed for the normality of the variables, either the Student's T test or the Mann Whitney U test will be used to compare both groups. With the same criteria for normality either Pearson or Spearmen correlation will be used among the cytokines and anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical analysis will be carried out in the Statistical Package for the Social Sciences (SPSS) program, version 19."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women older than 18 years old attender at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, located in Toluca City.\n\nFor a population of 8500 pregnant women annually attended, and a margin of error of 11%, the sample should be of 79 people.', 'genderDescription': 'Pregnant women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent.\n\nExclusion Criteria:\n\n* Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.'}, 'identificationModule': {'nctId': 'NCT03761966', 'briefTitle': 'Cytokines Profile at the Beginning of Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Materno-Perinatal Hospital of the State of Mexico'}, 'officialTitle': 'Cytokines Profile at the Beginning of Pregnancy in Mexican Women', 'orgStudyIdInfo': {'id': '217B500402015066'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Pregnant women older than 18 years old atended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM).', 'interventionNames': ['Other: Pregnant women']}], 'interventions': [{'name': 'Pregnant women', 'type': 'OTHER', 'armGroupLabels': ['Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50130', 'city': 'Toluca', 'country': 'Mexico', 'facility': 'Materno-Perinatal Hospital "Mónica Pretelini"', 'geoPoint': {'lat': 19.28786, 'lon': -99.65324}}], 'overallOfficials': [{'name': 'Hugo Mendieta Zerón, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The final data will be available upon request if requiered by the selected journal to publish the final manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materno-Perinatal Hospital of the State of Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Autonoma del Estado de Mexico', 'class': 'OTHER'}, {'name': 'Ciprés Grupo Médico CGM SC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Research Department', 'investigatorFullName': 'Hugo Mendieta Zeron', 'investigatorAffiliation': 'Materno-Perinatal Hospital of the State of Mexico'}}}}