Information for pregnant women in the BiSC study:
Barcelona Life Study Cohort

This fact sheet provides details of a research project in which we propose to participate. Please read this information carefully and do not hesitate to ask all the questions you consider.

Why are we doing this study on environmental exposure during pregnancy?

Some studies suggest that environmental contamination may be associated with diseases or disorders during fetal growth and infant development, but the scientific evidence is inconclusive. We are all exposed to environmental pollution, so it is important to investigate the effects that may occur in health. This is especially important in the pre and postnatal period, since the brains of babies are in full development and their structures are forming.

How can we know the exposure of mothers to these factors?

In this study we will make a detailed assessment of the environmental contaminants to which you may be exposed during pregnancy. We will collect information on the different environmental pollutants, such as compounds emitted by vehicle traffic and noise with personal and environmental sensors at home and in the city during different stages of gestation. At the end of the study we will combine all these measures with the results of the children’s health tests in order to better understand how these exposures can have an effect on the growth and development of babies.

What is the study?

Our goal is to include 1,200 pregnant women who make their follow-up visits to hospitals in Barcelona: BCNatal (which includes the San Juan de Dios Hospital and the Clinical-Maternity Hospital) and the Hospital of Santa Cruz and San Pablo. Women who agree to participate will receive a detailed evaluation of their environmental exposure in two periods of one week each during the first and third trimesters of pregnancy. This means that for each of these 1,200 mothers we will obtain measures of exposure to different environmental pollutants. The details of the tests are explained below.

What should I do if I decide to participate?

Your participation is voluntary, that is, you are the one who decides if you want to participate in the study.

As part of the investigation you will be asked:

• Sign an informed consent.
• Complete questionnaires about lifestyle (tobacco, alcohol consumption, physical activity, etc.), characteristics of the home and socio-demographic characteristics (age, sex, place of work and place, education, etc.) and clinical history.
• Perform a test to assess cognitive aspects (IQ) and mental health (SCL-90, parq, EPDS).
• Carry a mobile phone, a GPS and an accelerometer to measure your mobility and physical activity for two periods of a week.
• Take a backpack for two 48-hour periods, with sensors that measure their exposure to atmospheric pollutants.
• Put some air pollution monitors and noise meters outside the window of your house.
• Allow to collect information about your medical history during your pregnancy (weight, height, date of pregnancy, blood pressure, ultrasound and complications during pregnancy).
• Allow to collect blood samples (18 ml.) During the first and third trimesters of pregnancy.
• Allow to collect a hair sample to examine stress levels during pregnancy.
• Collect the first and last urine of the day and store it in the freezer for a week in the first and third trimesters of pregnancy.
• Collect a vaginal smear to measure the pattern of microbes (microbiome) at the time of the ultrasound.
• Allow to preserve samples (biopsies) of the placenta and cord blood once it has been expelled.

Biological samples (blood, urine, hair, placenta and cord blood) will be kept in hospital biobanks, following current national regulations, and will be analyzed in future studies on biomarkers of the impact of the environment on health (levels of pollutants , its metabolites, or its epigenetic, biochemical or hormonal marks).

If you decide to participate, you can lead a completely normal life without changing your habits. The weeks of monitoring the environmental exposure should be a normal week for you.

An investigator will arrange the collection of the monitors when the sampling is finished. A few months later we will contact you again to start the second week of follow-up.

What if I decide to retire?

Your participation in the study is totally voluntary. You have the right to withdraw from the study at any time. Your medical assistance will not be affected in any way.

In case you decide to leave the study, we will save the data obtained so far.

What tests will be done to the participating babies?

When your baby is born, you will be asked for informed consent so that your child can participate in

When your baby is born, you will be asked for informed consent so that your child can participate in the study. Clinical data of the baby will be obtained at the time of birth, and will be followed up at 6 and 18 months in which psychometric tests will be performed to measure the development of the baby, are similar to games tests. A few babies (approximately 400) will be asked to do a brain MRI before 3 months. The magnetic resonance is a test that allows to visualize the internal organs, in this case the brain. It is a test that does not emit any harmful radiation for the baby, and its realization is done in such a way that the welfare of the baby is guaranteed at all times.

What advantages do I have for participating in this project?

It is a good opportunity to be part of an important and powerful structure of research on the environment and health. The main advantage of taking part is that it will help us to better understand the effects that environmental contamination can have on the health of babies. These studies are very relevant because they provide scientific evidence on the effect of environmental factors on health. This evidence allows the development of new public health policies that reduce exposure to these pollutants to ensure better health for all, especially for children.

What should I do to know the results of the project?

You will receive a report on the levels of personal contamination and address, as well as physical activity. The results of the project will be published in scientific journals. No publication will identify individuals individually. No individual results will be available and the anonymity of its participants will be respected at all times.

Who is organizing this investigation?

This research is organized by the Barcelona Global Health Institute (ISGlobal), in collaboration with BCNatal (San Juan de Dios Hospital and the Maternidad Clinical Hospital) and the Hospital of Santa Cruz and San Pablo

How do we treat the information we collect and how we guarantee the confidentiality and protection of your personal data?

The data will be treated with absolute confidentiality and in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and free movement of these data.

Health data will be kept separate from personal data. Dissociating the data means that your health information can not be associated with you because your personal information is replaced by a code. Dissociated information will file to be used by the project researchers and their research partners. All the results of the study will be presented in a database of the group of participants, never presenting data individually.