PregnancyPRINCENCT05002023
PRINCE Study - Cohort Study of Healthy Pregnant Women Followed by the Assessment of Children´s Health and Immunity
An observational study of Pregnancy and Immune System Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Immune System Disorder
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2011to 31 Dec 2050
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Pregnant women
- >18 years of age
- able to understand and sign the papers of consent
- singleton pregnancy
Who cannot join
- <18 years of age
- unable to give consent
- multiple pregnancy
- nicotine abuse
- fetal aberration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Franziska Rüber, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Immune System Disorder
- Keywords
- Pregnancy, Immune System, Birth cohort, Fetal Programming
- Medical subject headings
- Immune System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years follow up
Secondary outcomes (3)
influences during pregnancy that potentially affect children´s health
assessed by maternal examination during pregnancy including ultrasound in every trimester
Measured: 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 (...)
Measured: 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
Measured: 10 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start2 Feb 2011
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anke Diemert, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Prof. Dr. Anke Diemert, MD, Principal investigator, Department of Obstetrics and Fetal Medicine, Medical Center Hamburg-Eppendorf (UKE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002023
- Sponsor's protocol ID
- PV3694
- Acronym
- PRINCE
- Status last verified
- Aug 2021
- First submitted
- 27 Apr 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes