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Impact of Particulate Matter on Mothers and Babies in Antwerp (IPANEMA) (IPANEMA)

30 novembre 2016 mis à jour par: Prof Yves Jacquemyn, Universiteit Antwerpen

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

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).

Aim: 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.

Methods: 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.

Results and conclusion: As the study will start in November 2014, no results are available yet.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

Blood collections (maternal and umbilical cord) Venous blood is drawn around 24 weeks of gestational age.

Table 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

Umbilical cord blood is taken at time of birth. Table 2 Tests on umbilical blood sample VITO m(i)RNA expression, telomere length, DNA methylation

Urine 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).

Two urine samples are collected: at 20 weeks and at 30 weeks gestational age. 8 oxo deoxyguanosine will be determined in the samples.

Hair 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.

Collection 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.

Questionnaires

There are four different questionnaires:

Questionnaire 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).

Questionnaire 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.

Questionnaire 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.

Questionnaire 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.

Questionnaires 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

Type d'étude

Observationnel

Inscription (Anticipé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Antwerp
      • Edegem, Antwerp, Belgique, 2650
        • Recrutement
        • University Hospital Antwerp
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 50 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

Inclusion Criteria:

  • A singleton pregnancy from 12 weeks of gestational age
  • Delivery planned in a hospital within the network of the Antwerp University
  • Dutch speaking

Exclusion Criteria:

  • Multiple pregnancy
  • Planned home delivery of in another hospital

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
preeclampsia
Délai: From date of randomization until the date of delivery
From date of randomization until the date of delivery

Mesures de résultats secondaires

Mesure des résultats
Délai
birth weight
Délai: at delivery, assessed up to 40 weeks
at delivery, assessed up to 40 weeks
preterm birth
Délai: at delivery, assessed up to 40 weeks
at delivery, assessed up to 40 weeks
gestational diabetes
Délai: From date of randomization until the date of delivery
From date of randomization until the date of delivery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: yves jacquemyn, PhD, Universiteit Antwerpen

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2015

Achèvement primaire (Anticipé)

1 avril 2017

Achèvement de l'étude (Anticipé)

1 avril 2018

Dates d'inscription aux études

Première soumission

22 octobre 2015

Première soumission répondant aux critères de contrôle qualité

28 octobre 2015

Première publication (Estimation)

30 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 décembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 novembre 2016

Dernière vérification

1 novembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 14/40/411

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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