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

PRINCE - PRenatal Identification of Childrens HEalth

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Immune System Disorder

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Prof. Dr. Anke Diemert, MD; Phone Number: 0049 +40 7410- 57832; Email: a.diemert@uke.de
• Study Contact Backup: Name: Lina Otto; Phone Number: 0049 +43 7410-58706; Email: l.otto@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitatsklinikum Hamburg-Eppendorf
    • Contact: Franziska Rüber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The PRINCE cohort includes healthy or diseased pregnant women aged 18-45 years. Women gaining knowledge of the study from their gynecologist, in the clinic or from other participants.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
influences during pregnancy that potentially affect children´s health	assessed by maternal examination during pregnancy including ultrasound in every trimester	10 years follow up
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
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Prof. Dr. Anke Diemert, MD, Department of Obstetrics and Fetal Medicine, Medical Center Hamburg-Eppendorf (UKE)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2011
• Primary Completion (Anticipated): December 31, 2050
• Study Completion (Anticipated): December 31, 2050

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Immune System; Birth cohort; Fetal Programming
• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: PV3694