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

Last updated: August 20, 2021
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

N/A

Clinical Study ID

NCT05002023
PV3694
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women
  • >18 years of age
  • able to understand and sign the papers of consent
  • singleton pregnancy

Exclusion

Exclusion Criteria: :

  • <18 years of age
  • unable to give consent
  • multiple pregnancy
  • nicotine abuse
  • fetal aberration

Study Design

Total Participants: 1000
Study Start date:
February 02, 2011
Estimated Completion Date:
December 31, 2050

Study 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.

Connect with a study center

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

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