Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 11:35 AM
Study NCT ID:
NCT04047966
Status:
TERMINATED
Last Update Posted:
2020-11-05
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'We will recruit fecal samples to obtain bacterial DNA for metagenomics analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to the current pandemic situation, recruitment has been disrupted by the inability to recruit more patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal microbiome composition (16S RNA amplicon sequencing)', 'timeFrame': 'From May to July 2020', 'description': 'To determine the main gastrointestinal microbiota composition, by 16S RNA amplicon sequencing, in fecal samples of pregnant women and their newborn (meconic)'}], 'secondaryOutcomes': [{'measure': 'Plasma levels of inflammatoy biomarkers', 'timeFrame': 'From May to July 2020', 'description': 'To determine plasma inflammatory biomarkers levels (LPS, LBP, IL6, 8, 10, 13,15 IFN-gamma, VEGF) in pregnant woman by inmunoassay determination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrauterine Growth restriction', 'Gastrointestinal microbiome', 'Inflammatory biomarkers'], 'conditions': ['Intrauterine Growth Restriction']}, 'descriptionModule': {'briefSummary': 'It is an observational and prospective study that will include consecutively 63 controls (fetuses with estimated fetal weight above the 10th centile) and 63 fetuses with defects in fetal growth (estimated fetal weight below the 10th percentile) during the third trimester (32-26 weeks) with gestational age at birth equal or over 37 weeks. Investigators will collect: (1) Obstetric and nutritional questionnaires, (2) maternal samples between 32-36 weeks (feces), (3) intrapartum samples (maternal blood, cord blood and placenta) and (4) postpartum samples (meconic and newborn feces at 6 weeks of life)', 'detailedDescription': 'It is an observational and prospective study to determine the influence of the gastrointestinal microbiome on the intrauterine growth restriction (IUGR). For this purpose, investigators are planning to recruit 63 women with a diagnoses of IUGR and 63 pregnant women with a normal intrauterine growth.\n\nSamples will be taken during third trimester (fecal and blood maternal sample), intrapartum (maternal blood, umbilical cord blood and placenta tissue sample) and post partum samples (meconic and newborn fecal samples at 6 weeks of life).\n\nAlso, obstetric and nutritional information will be registered by means of specific questionnaires.\n\nFecal samples will be use to study the gastrointestinal microbiome by Next Generation Sequencing techniques, whereas inflammatory biomarkers will be determine in plasma samples.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '63 controls (fetuses with estimated fetal weight above the 10th centile) and 63 fetuses with defects in fetal growth (estimated fetal weight below the 10th percentile) during the third trimester (32-26 weeks) with gestational age at birth equal or over 37 weeks.', 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intrauterine Growth restriction (32-36 weeks)\n* Vaginal delivery\n* Delivery at 37 weeks\n\nExclusion Criteria:\n\n* Alcohol, tabacco or other drugs consumption during pregnancy\n* Antibiotic use before recruitment (3 months) or during pregnancy until delivery\n* Gestational diabetes\n* Fetuses anormalities'}, 'identificationModule': {'nctId': 'NCT04047966', 'acronym': 'BIOCIR', 'briefTitle': 'Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers', 'orgStudyIdInfo': {'id': 'UGranada'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fetal growth restriction', 'description': '63 fetuses with defects in fetal growth qith an estimated fetal weight below 10th percentile'}, {'label': 'Control group', 'description': '63 control fetuses with an estimated fetal weight about the 10th percentile'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08950', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Obstetrics and Gynecology, Hospital Sant Joan de Déu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Carolina Gomez Llorente, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Sant Joan de Deu', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carolina Gómez Llorente', 'investigatorAffiliation': 'Universidad de Granada'}}}}