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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05002023
Other study ID # PV3694
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2011
Est. completion date December 31, 2050

Study information

Verified date August 2021
Source Universitätsklinikum Hamburg-Eppendorf
Contact Prof. Dr. Anke Diemert, MD
Phone 0049 +40 7410- 57832
Email a.diemert@uke.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2050
Est. primary completion date December 31, 2050
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Types of allergic diseases in childhood 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. 10 years follow up
Secondary influences during pregnancy that potentially affect children´s health assessed by maternal examination during pregnancy including ultrasound in every trimester 10 years follow up
Secondary influences during pregnancy that potentially affect children´s health assessed by questionaire every trimester with questions about nutrition, infections, medication, stress (...) 10 years follow up
Secondary influences during pregnancy that potentially affect children´s health assessed by analysing blood samples of the mother in every trimester and analysing cord blood 10 years follow up
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