Immune System Disorder, Pregnancy
Conditions
Keywords
Pregnancy, Immune System, Birth cohort, Fetal Programming
Brief summary
In the PRINCE study we recruit healthy but also diseased pregnant women into a cohort study, followed by the assessment of children´s health and immunity at birth and during the first 10 years of life. This unique cohort allows for testing the impact of prenatal challenges on children´s health.
Detailed description
Children´s Health is critically dependent of the prenatal well-being of the mother, and a number of observational studies have identified an impaired immunity in children upon prenatal challenges, such as stress perception, medication, nutrition or infection. However, concerted, in-depth studies assessing how such prenatal challenges may alter fetal development and subsequently children´s health in humans are largely lacking. In the present project, we address this limitation by recruiting healthy, but also diseased pregnant women into a cohort study, followed up by the assessment of children´s health and immunity at birth and during the first ten years of life. Study participants are recruited early in the first trimester (12-15 weeks of gestation). By means of data security all participants receive a study number. Data processing into the data base (Redcap) is performed under this pseudonym. During the first visit, the study team explains the enrollment conditions and the participants are asked to give their consent. Study visits include the documentation of clinically important conditions, sonographic examination of the fetus, assessment of mother´s height and weight as well as blood collection (21 ml) of the mother. Additionally we document any kind of medication-intake and nutrition data, and the participants are asked to fill in a psychometric questionnaire. Study visits are scheduled according to the week of gestation, i.e. around 13th, 20th (ultrasound only), 24th, 28th, 34th week. If women give birth in our clinic, we are able to collect cord blood after birth. Blood samples are processed immediately and stored in our laboratory under Biobank-conditions.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women * \>18 years of age * able to understand and sign the papers of consent * singleton pregnancy
Exclusion criteria
: * \<18 years of age * unable to give consent * multiple pregnancy * nicotine abuse * fetal aberration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Types of allergic diseases in childhood | 10 years follow up | The different types of allergic diseases are assessed by a yearly questionnaire, a pediatric examination and lung function testing of the child aged 5 and 9 1/2 years, as well as analysing blood samples of the child aged 5 and 9 1/2 years. Main allergies we measure are inhalation allergens and infant food. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| influences during pregnancy that potentially affect children´s health | 10 years follow up | assessed by maternal examination during pregnancy including ultrasound in every trimester |
Countries
Germany
Contacts
Primary ContactProf. Dr. Anke Diemert, MD
Backup ContactLina Otto
Outcome results
None listed