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

NCT02592005 | Unknown

• 1 other identifier: 14/40/411
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Preeclampsia

Keywords

pollution

Outcome Measures

Primary Outcomes (1)

• preeclampsia

  From date of randomization until the date of delivery

Secondary Outcomes (3)

• birth weight

  at delivery, assessed up to 40 weeks

• preterm birth

  at delivery, assessed up to 40 weeks

• gestational diabetes

  From date of randomization until the date of delivery

Interventions

amount of fine dust and other environmental exposure OTHER

this study compares levels of exposure to to fine dust PM 2.5 by individual measurement both at home and at work

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Multiple pregnancy
• Planned home delivery of in another hospital

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 33573648 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

maternal blood maternal hair maternal urine umbilical cord blood

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• yves jacquemyn, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yves jacquemyn, PhD

CONTACT

003238215945; yves.jacquemyn@uza.be

Leen van den eeden, MD

CONTACT

003238213350; leen.vandeneeden@thomasmore.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Obgyn

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 30, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

BE (1)