Actively Recruiting
PRINCE - PRenatal Identification of Childrens HEalth Cohort Study of Pregnant Women and Long-Term Child Health Assessment
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2021-08-26
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting the PRINCE study to observe how prenatal factors affect children's health and immune systems. This cohort study includes both healthy and diseased pregnant women and follows their children from birth through the first 10 years of life. The study aims to understand how challenges during pregnancy, such as stress, medication, nutrition, or infection, might influence fetal development and long-term child health. Participants are recruited early in pregnancy, between the 12th and 15th weeks of gestation. Study visits occur throughout pregnancy at approximately the 13th, 20th, 24th, 28th, and 34th weeks, involving clinical documentation, fetal ultrasound, maternal measurements, blood collection, and questionnaires about medication use, nutrition, and psychological state. Cord blood is collected at birth for further analysis, with samples stored under biobank conditions. Throughout the study, participants provide data on their health and pregnancy, and their children are monitored for allergic diseases and other health outcomes over a 10-year period. Researchers assess prenatal influences on children's health using sonographic exams, blood tests, and psychometric questionnaires. All data are securely processed and pseudonymized to protect participant privacy, with the study continuing until 2050.
CONDITIONS
Brief Title
PRINCE Study - Cohort Study of Healthy Pregnant Women Followed by the Assessment of Children´s Health and Immunity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women
- Over 18 years of age
- Able to understand and sign the papers of consent
- Singleton pregnancy
You will not qualify if you...
- Under 18 years of age
- Unable to give consent
- Multiple pregnancy
- Nicotine abuse
- Fetal aberration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From early first trimester (12-15 weeks) until birth
Participants are observed throughout pregnancy with scheduled visits including clinical documentation, sonographic examinations, blood collection, and questionnaires to assess factors affecting child health.
Visits around weeks 13, 20, 24, 28, and 34 of gestation
Duration - Up to 10 years after birth
Children's health and immunity are assessed at birth and followed up over the first ten years of life to monitor development and allergic diseases.
Initial cord blood collection at birth if delivery occurs in the clinic; follow-up visits schedule varies over 10 years
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
Research Team
P
Prof. Dr. Anke Diemert, MD
L
Lina Otto
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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