Pregnancy and Infant Development Study

The PRIDE Study will be conducted to gain more knowledge about the causes of
maternal and infant disorders and diseases that originate in pregnancy,
including gestational hypertension, spontaneous abortions, and major birth
defects. Knowledge about risk factors for these disorders and diseases is
limited, but an influence of both genetic and environmental factors are
described in the medical scientific literature. For example, for 60-70% of
birth defects the cause is unknown and knowledge about the aetiology of
pregnancy-related disorders and diseases that are diagnosed during early
childhood, such as diabetes, autism, childhood cancer, and obesitas, is very
limited. Within this research area, a significant number of studies have been
conducted, but it is impossible to draw firm conclusions due to methodological
limitations, including the retrospective assessment of exposure, inadequate
data on exposure status and/or outcomes, and lack of study power. The design of
the PRIDE Study will overcome these methodological shortcomings. For a more
detailed description of the background of the PRIDE Study, please see the study
protocol.

The primary objective of the PRIDE Study is to identify factors to which a
woman is exposed during her pregnancy that have an influence on the health
status of the mother and/or her (unborn) child. In addition, the evaluation of
preconception, prenatal, and perinatal care in the Netherlands (counselling,
screening, prenatal diagnostic procedures, etc.) is an important aim within the
PRIDE Study. Three specific objectives for the PRIDE Study have been
formulated: (1) to describe the distribution of determinants during pregnancy
and to estimate incidences and prevalences of various outcomes, (2) to evaluate
preconception, prenatal, and perinatal care in the Netherlands, and (3) to
study which prenatal factors influence maternal and/or child health.

Prospective cohort study. Smaller cohorts of women with a specific exposure,
such as use of medication and working with chemical pesticides, will be
followed in more detail, and will possibly be asked to provide blood samples.
The data collection will primarily be conducted using web-based questionnaires.
The participants will be asked to complete a questionnaire at gestational weeks
8-10, 17, and 34, as well as 6 months after the estimated date of delivery.

De belangrijkste belasting voor de deelnemende vrouwen bestaat uit het 4 maal
(digitaal) invullen van een vragenlijst, hetgeen 10 to 20 minuten per keer zal
kosten. Daarnaast kan eventueel nog een voedingsvragenlijst worden ingevuld en
de partner vult eenmalig een vragenlijst in met een gelijke tijdsbelasting. Een
deel van de vrouwen zal ook gevraagd worden eenmalig deel te nemen aan een
bloedonderzoek, dat ofwel gelijktijdig met het bloedonderzoek voor de
zwangerschapscontrole plaatsvindt ofwel een aparte bloedprik vereist. Er
bestaan geen risico*s voor vrouwen die uitsluitend deelnemen aan het
vragenlijstonderzoek. De overige vrouwen lopen alleen enig (verwaarloosbaar)
risico bij de standaard bloedafname (3 extra buisjes) of bij de extra
bloedafname t.b.v. de PRIDE Study.

De main burden for the participating women consists of completion of 4
questionnaires which will cost 10 to 20 minutes each. In addition, a food
frequency questionnaire can be filled out and the partner completes one
questionnaire of approximately the same lenght. Part of the women will also be
asked to donate 3 blood samples which will be drawn at the same time as the
regular blood samples for the pregnancy check-up or be means of an extra blood
draw. There are no risks for women who participate in the questionnaire study
only. The other women run a negligible risk at the standard or extra blood
draw.