PRINCE Study - Cohort Study of Healthy Pregnant Women Followed by the Assessment of Children´s Health and Immunity

Pregnancy Clinical Trial

— PRINCE  

Official title:

PRINCE - PRenatal Identification of Childrens HEalth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002023
• Other study ID #: PV3694
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Immune System Diseases
• Immune System Disorder
• Pregnancy

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