AzTrials
AzTrials

PregnancyIPANEMANCT02592005

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

An observational study of Pregnancy and Preeclampsia, run by Universiteit Antwerpen at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Preeclampsia
What is being tested?
amount of fine dust and other environmental exposure
How many people
200 participants
Where
1 siteBelgium
Study dates
May 2015to Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • Multiple pregnancy
  • Planned home delivery of in another hospital

Trial locations and contacts

1 site in 1 country.

yves jacquemyn, PhD contact

003238215945

yves.jacquemyn@uza.be

Leen van den eeden, MD contact

003238213350

leen.vandeneeden@thomasmore.be

Belgium1 site, 1 recruiting
  • University Hospital Antwerp

    Edegem, Antwerp, 2650

    Yves Jacquemyn, Phd, +3238215945, yves.jacquemyn@uza.be

    Lena EM Van den Eeden, MD, +3214564450, leen.vandeneeden@thomasmore.be

    Recruiting

Other trials in Belgium

About this study

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

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.

Read more

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.

Read the detailed description

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

Being tested
amount of fine dust and other environmental exposure
Keywords
pollution
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amount of fine dust and other environmental exposureOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. preeclampsia

    Measured: From date of randomization until the date of delivery

Secondary outcomes (3)
  1. birth weight

    Measured: at delivery, assessed up to 40 weeks

  2. preterm birth

    Measured: at delivery, assessed up to 40 weeks

  3. gestational diabetes

    Measured: From date of randomization until the date of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionApr 2017 (estimated)
  4. Study completionApr 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592005
Sponsor's protocol ID
14/40/411
Acronym
IPANEMA
Status last verified
Nov 2016
First submitted
22 Oct 2015
Last updated
1 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33573648

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Preeclampsia, run by Universiteit Antwerpen at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yves jacquemyn, PhD (003238215945, yves.jacquemyn@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

preeclampsia (time frame: From date of randomization until the date of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02592005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in