RecruitingOBSERVATIONAL

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

The groundbreaking PRINCE study aims to understand how a mother's health and experiences during pregnancy can impact her child's well-being and immune system. Researchers are inviting pregnant women, both healthy and those with certain conditions, to join this study. They will then closely follow the children from birth up to 10 years of age. This unique research will help us learn more about how things like stress, diet, medication, or infections experienced by the mother during pregnancy might influence a baby's development and long-term health. The goal is to gather vital information that could ultimately lead to better health for future generations.

At a glance

Status

Recruiting

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

1,000

Start

02 Feb 2011

Estimated completion

31 Dec 2050

Pregnancy Immune System Disorder

What is this study about?

The PRINCE study is an important research project looking into the health of pregnant women and their children. Scientists have noticed that a mother's health and life experiences during pregnancy can play a big role in her child's health later on, especially their immune system (which helps fight off illness).

Previous studies have hinted that things like stress, certain medicines, what a mother eats, or infections during pregnancy might affect a child's development. However, we don't fully understand how these 'challenges' during pregnancy truly change how babies develop and how healthy they are as they grow up. This study aims to fill that gap.

The PRINCE study is inviting pregnant women – both those who are healthy and those with certain medical conditions – to join. The research team will then closely watch the children's health and immune system development from the time they are born through their first 10 years of life. This detailed tracking will help us learn more about how a mother's prenatal experiences might impact her child’s long-term health.

Key takeaways

The PRINCE study looks at how a mother's health in pregnancy affects her child's long-term health and immune system.
It involves following pregnant women and their children up to 10 years of age.
Participation includes clinic visits, blood tests, and questionnaires during pregnancy.
The study aims to understand the impact of factors like stress, diet, and medication during pregnancy.
Your privacy is protected, and you can leave the study at any time.

Who may be eligible?

To be part of the PRINCE study, you must be a pregnant woman who is at least 18 years old. You should also be carrying one baby (not twins or more) and be able to understand and sign the consent forms.

The study cannot include you if you are under 18, are unable to give your agreement to take part, are expecting more than one baby, smoke, or if your baby has certain abnormalities that have already been identified. These rules help make sure the study collects information consistently from healthy pregnancies or those with specific conditions under investigation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant?
Are you 18 years old or older?
Are you expecting only one baby?
Do you feel able to understand and sign consent forms?
Do you not smoke?
Has your baby not been identified with any significant abnormalities yet?

Answer every question to see your result.

What does participation involve?

If you decide to join the PRINCE study, you'll be asked to come to several appointments during your pregnancy, starting around weeks 12-15. These visits often happen around weeks 13, 20 (for an ultrasound only), 24, 28, and 34 of your pregnancy. During these appointments, the study team will check your general health, measure your height and weight, and perform ultrasound scans of your baby.

You'll also be asked to provide a small blood sample (about 21ml, which is approximately 4 teaspoons). The team will also record any medications you're taking and details about your diet. You'll also fill out a questionnaire about your feelings and well-being. If you give birth at the clinic involved in the study, they may also collect blood from your baby's umbilical cord after birth. Your information will be kept private and stored using a special study number.

Potential risks and benefits

Taking part in a study like PRINCE helps doctors and researchers learn more about pregnancy and child health, which could lead to better care for future families. The main procedures involve clinic visits and blood tests, which carry very small risks, similar to routine antenatal care. You might feel a little discomfort from blood collection. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Universitätsklinikum Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is an 'immune system' and why is it important?

Your immune system is your body's natural defence against illnesses, infections, and other harmful invaders. A healthy immune system helps you stay well.

What does 'prenatal challenges' mean?

This refers to experiences or situations during pregnancy that might affect the mother or developing baby, such as stress, changes in diet, certain medicines, or infections.

How often would I need to visit the clinic?

You would have several visits during your pregnancy, typically around weeks 13, 20, 24, 28, and 34.

Will my personal information be kept private?

Yes, all your information will be kept confidential and identified by a study number, not your name, to protect your privacy.

What happens after my baby is born?

The study will continue to follow your child's health and development from birth for up to 10 years, which may involve regular check-ups or collecting health information.

How to find out more

Prof. Dr. Anke Diemert, MD

a.diemert@uke.de 0049 +40 7410- 57832 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.