Clinical trial NCT05002023: PRINCE Study - Cohort Study of Healthy Pregnant Women Followed by the Assessment of Children´s Health and Immunity
Official title: PRINCE - PRenatal Identification of Childrens HEalth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Immune System Disorder
Keywords: Pregnancy
Immune System
Birth cohort
Fetal Programming
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Types of allergic diseases in childhood
timeFrame: 10 years follow up
Secondary outcomes:
measure: influences during pregnancy that potentially affect children´s health
timeFrame: 10 years follow up
measure: influences during pregnancy that potentially affect children´s health
timeFrame: 10 years follow up
measure: influences during pregnancy that potentially affect children´s health
timeFrame: 10 years follow up
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Department of Obstetrics and Fetal Medicine, Medical Center Hamburg-Eppendorf (UKE)
name: Prof. Dr. Anke Diemert, MD
role: PRINCIPAL_INVESTIGATOR
References: