Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT02592005
Status:
UNKNOWN
Last Update Posted:
2016-12-01
First Post:
2015-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Particulate Matter on Mothers and Babies in Antwerp (IPANEMA)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'maternal blood maternal hair maternal urine umbilical cord blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-10-28', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preeclampsia', 'timeFrame': 'From date of randomization until the date of delivery'}], 'secondaryOutcomes': [{'measure': 'birth weight', 'timeFrame': 'at delivery, assessed up to 40 weeks'}, {'measure': 'preterm birth', 'timeFrame': 'at delivery, assessed up to 40 weeks'}, {'measure': 'gestational diabetes', 'timeFrame': 'From date of randomization until the date of delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pollution'], 'conditions': ['Pregnancy', 'Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '33573648', 'type': 'DERIVED', 'citation': 'Verheyen VJ, Remy S, Lambrechts N, Govarts E, Colles A, Poelmans L, Verachtert E, Lefebvre W, Monsieurs P, Vanpoucke C, Nielsen F, Van den Eeden L, Jacquemyn Y, Schoeters G. Residential exposure to air pollution and access to neighborhood greenspace in relation to hair cortisol concentrations during the second and third trimester of pregnancy. Environ Health. 2021 Feb 11;20(1):11. doi: 10.1186/s12940-021-00697-z.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: An emerging body of evidence indicates that there is an association between air pollution exposure in pregnancy and adverse pregnancy outcomes (Rudra, Williams, Sheppard , Koenig, \\& Schiff, 2011; Dadvand, et al., 2013; Ritz, et al., 2014). Adverse pregnancy outcomes tend to lead to adverse neonatal outcome and a higher economic cost. Epidemiologic studies have also revealed that cardiovascular complications during pregnancy, such als preeclampsia, are associated with a greater cardiovascular risk during later life ( Abramson \\& Melvin, 2014).\n\nAim: This study wants to examine the effects of exposure to environmental factors, polluents and particulate matter on the clinical pregnancy outcome for mother and child and to determine which biochemical changes in maternal, placental and cord blood best explain this effect.\n\nMethods: This study will be performed in a prospective cohort setup (n=200), recruited from the prenatal clinic in the University Hospital Antwerp. The data collection consists of four questionnaires (intake, both urine samples and postpartum), two blood samples (28 weeks and post-partum), two urine samples (20 and 30 weeks), two hair samples (20 weeks and post-partum), cord blood and the placenta.\n\nResults and conclusion: As the study will start in November 2014, no results are available yet.', 'detailedDescription': 'Blood collections (maternal and umbilical cord) Venous blood is drawn around 24 weeks of gestational age.\n\nTable 1 Tests on maternal blood sample:Routine blood sampling (UZA) Urea, Creatinin, CRP, LDH, AST, ALT, Uric acid, APTT, PT, Fibrinogen, D-dimers, Glucose, Erythrocytes/hematocrit, Hemoglobin, Thrombocytes, Leukocytes, Ferritin, Toxoplasmosis (IgG \\& IgM), CMV (IgG \\& IgM), Herpes simplex IgG, Varicella zoster IgG, Rubella IgG, Parvovirus (IgG \\& IgM), Syphilis (RPR \\& TPHAM), Indirect Coombs AML sFlt-1, PlGF, Cystatin C VITO m(i)RNA expression, telomere length, DNA methylation\n\nUmbilical cord blood is taken at time of birth. Table 2 Tests on umbilical blood sample VITO m(i)RNA expression, telomere length, DNA methylation\n\nUrine collections Urine samples are taken by the pregnant women themselves, after a minimum of 8 hours fasting (morning urine). Samples are handed to the midwife at the antenatal visit, and placed at -20°C freezer within 12 hours of collection. Analysis will be performed at the Flemish Institute for Technological Research (VITO).\n\nTwo urine samples are collected: at 20 weeks and at 30 weeks gestational age. 8 oxo deoxyguanosine will be determined in the samples.\n\nHair collections Hair samples are drawn by the midwife around 24 weeks of gestational age and three days after delivery. Long periods of stress are associated with increased hair cortisol concentrations (Stalder \\& Kirschbaum, 2012). Confounding variables are low maternal education, season of delivery, smoking during pregnancy and obesity (Braig, et al., 2015).Titanium scissors are cleaned with denaturated ethanol and the midwife wears disposable gloves in order to limit contamination. A lock of hair with a thickness of a match (2 mm) and a length of 4 cm will be taken and put in an envelope. Analysis will be performed at the University of Southern Denmark.\n\nCollection of particulate matter on bedroom window Participants will be asked to clean their bedroom window with clear water on the in- and outside around 24 weeks of gestation. A poster (A4 format) will then be attached to the window to create a standardized area for the measurement of magnetic particles. After minimal 4 weeks, the area in the poster is cleaned with a sterile pre-injection swab, on both sides of the window. Swabs are transported in a plastic bag and the ferro(i)magnetic particulate matter fraction will be quantified by Saturated Isothermal Remanent Magnetization.\n\nQuestionnaires\n\nThere are four different questionnaires:\n\nQuestionnaire on general habits, socio-economic factors, lifestyle and eating habits A self-designed questionnaire is used to extensively collect information on ethnic origin and and education level, on employment, income and work environment, on family history of diseases and chronic disorders, on eating habits, on previous pregnancies and other habits (smoking, alcohol consumption).\n\nQuestionnaire on lifestyle during previous 3 days A self-designed questionnaire is used to extensively collect information on contact with possible toxic factors and on eating pattern of the previous 3 days.\n\nQuestionnaire on residential facts A self-designed questionnaire is used to collect information about the exact location of the bedroom window and other possible factors influencing concentrations of particulate matter.\n\nQuestionnaire on stress factors and birth facts A self-designed questionnaire is used to extensively collect information on stress levels during pregnancy, on birth facts and on medication during pregnancy.\n\nQuestionnaires will be taken at different visits:\\< 12 weeks 20 weeks 30 weeks birth Questionnaire on general habits, socio-economic factors, lifestyle and eating habits Recruitment Questionnaire on lifestyle during previous 3 days Urine sample 1 Urine sample 2 Questionnaire on residential facts 4-8 weeks prior to visit Questionnaire on stress factors and birth facts 3 days after birth'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women are recruited within the network of the Antwerp University. Leading centre will be the University Hospital Antwerp (UZA),a tertiary centre with a maternal intensive care unit (MIC) and a neonatal intensive care unit (NIC) and 1000 deliveries a year.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A singleton pregnancy from 12 weeks of gestational age\n* Delivery planned in a hospital within the network of the Antwerp University\n* Dutch speaking\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Planned home delivery of in another hospital'}, 'identificationModule': {'nctId': 'NCT02592005', 'acronym': 'IPANEMA', 'briefTitle': 'Impact of Particulate Matter on Mothers and Babies in Antwerp (IPANEMA)', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Impact of Particulate Matter on Mothers and Babies in Antwerp (IPANEMA), a Prospective Cohort Study on the Impact of Pollutants and Particulate Matter in Pregnancy: Methodology and Design', 'orgStudyIdInfo': {'id': '14/40/411'}}, 'armsInterventionsModule': {'interventions': [{'name': 'amount of fine dust and other environmental exposure', 'type': 'OTHER', 'description': 'this study compares levels of exposure to to fine dust PM 2.5 by individual measurement both at home and at work'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yves Jacquemyn, Phd', 'role': 'CONTACT', 'email': 'yves.jacquemyn@uza.be', 'phone': '+3238215945'}, {'name': 'Lena EM Van den Eeden, MD', 'role': 'CONTACT', 'email': 'leen.vandeneeden@thomasmore.be', 'phone': '+3214564450'}], 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'yves jacquemyn, PhD', 'role': 'CONTACT', 'email': 'yves.jacquemyn@uza.be', 'phone': '003238215945'}, {'name': 'Leen van den eeden, MD', 'role': 'CONTACT', 'email': 'leen.vandeneeden@thomasmore.be', 'phone': '003238213350'}], 'overallOfficials': [{'name': 'yves jacquemyn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Obgyn', 'investigatorFullName': 'Prof Yves Jacquemyn', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}