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

Pregnancy Clinical Trial

— IPANEMA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592005
• Other study ID #: 14/40/411
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2015
• Last updated: November 30, 2016
• Start date: May 2015
• Est. completion date: April 2018

Study information

• Verified date: November 2016
• Source: Universiteit Antwerpen
• Contact: yves jacquemyn, PhD
• Phone: 003238215945
• Email: yves.jacquemyn[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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). 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preeclampsia		From date of randomization until the date of delivery	No
Secondary	birth weight		at delivery, assessed up to 40 weeks	No
Secondary	preterm birth		at delivery, assessed up to 40 weeks	No
Secondary	gestational diabetes		From date of randomization until the date of delivery	No

External Links

•   local recruitment site