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

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ClinicalTrials.gov Identifier: NCT02592005
Recruitment Status : Unknown
Verified November 2016 by Prof Yves Jacquemyn, Universiteit Antwerpen.
Recruitment status was:  Recruiting
First Posted : October 30, 2015
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Prof Yves Jacquemyn, Universiteit Antwerpen

Brief Summary:

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.


Condition or disease Intervention/treatment
Pregnancy Preeclampsia Other: amount of fine dust and other environmental exposure

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: amount of fine dust and other environmental exposure
    this study compares levels of exposure to to fine dust PM 2.5 by individual measurement both at home and at work


Primary Outcome Measures :
  1. preeclampsia [ Time Frame: From date of randomization until the date of delivery ]

Secondary Outcome Measures :
  1. birth weight [ Time Frame: at delivery, assessed up to 40 weeks ]
  2. preterm birth [ Time Frame: at delivery, assessed up to 40 weeks ]
  3. gestational diabetes [ Time Frame: From date of randomization until the date of delivery ]

Biospecimen Retention:   Samples With DNA
maternal blood maternal hair maternal urine umbilical cord blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592005


Contacts
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Contact: yves jacquemyn, PhD 003238215945 yves.jacquemyn@uza.be
Contact: Leen van den eeden, MD 003238213350 leen.vandeneeden@thomasmore.be

Locations
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Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Yves Jacquemyn, Phd    +3238215945    yves.jacquemyn@uza.be   
Contact: Lena EM Van den Eeden, MD    +3214564450    leen.vandeneeden@thomasmore.be   
Sponsors and Collaborators
Universiteit Antwerpen
Investigators
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Principal Investigator: yves jacquemyn, PhD Universiteit Antwerpen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Yves Jacquemyn, Head of Obgyn, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02592005    
Other Study ID Numbers: 14/40/411
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Keywords provided by Prof Yves Jacquemyn, Universiteit Antwerpen:
pollution
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications