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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRINCE - PRenatal Identification of Childrens HEalth
- ClinicalTrials.gov ID
- NCT05002023
- Acronym / sponsor ID
- PRINCE / PV3694
- Conditions
- Pregnancy, Immune System Disorder
- Keywords
- Pregnancy, Immune System, Birth cohort, Fetal Programming
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 2 Feb 2011 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Pregnant women
- >18 years of age
- able to understand and sign the papers of consent
- singleton pregnancy
Key exclusion criteria (5 listed)
- <18 years of age
- unable to give consent
- multiple pregnancy
- nicotine abuse
- fetal aberration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types of allergic diseases in childhood
Time frame: 10 years follow up
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.
3 secondary outcomes
influences during pregnancy that potentially affect children´s health
Time frame: 10 years follow up
influences during pregnancy that potentially affect children´s health
Time frame: 10 years follow up
influences during pregnancy that potentially affect children´s health
Time frame: 10 years follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Anke Diemert, MD principal investigator
Department of Obstetrics and Fetal Medicine, Medical Center Hamburg-Eppendorf (UKE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Immune System Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Anke Diemert, MD (0049 +40 7410- 57832, a.diemert@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types of allergic diseases in childhood (time frame: 10 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.