Investigation of children from mothers with and without gestational diabetes
PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)
This study looks at how being exposed to high sugar levels in the womb affects the growth and health of children born to mothers with and without gestational diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT04722900 on ClinicalTrials.gov |
What this trial studies
This observational study examines the long-term effects of gestational diabetes on the development of children born to mothers with and without the condition. It aims to understand how intrauterine exposure to elevated glucose levels influences various developmental aspects in offspring from infancy to adulthood. The study includes children whose mothers were diagnosed with gestational diabetes and those who were not, allowing for a comparative analysis of outcomes. Participants will be monitored for developmental milestones and health outcomes over time.
Who should consider this trial
Good fit: Ideal candidates for this study are children born to mothers who have documented gestational diabetes as well as those born to mothers without the condition.
Not a fit: Patients with severe malformations or coagulation disorders that complicate examination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term health implications for children exposed to gestational diabetes, potentially guiding future prenatal care and interventions.
How similar studies have performed: While there have been studies on gestational diabetes, this specific investigation into long-term offspring outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signed informed consent provided by child and parent * documented oral glucose tolerance test of the mother during pregnancy * adequate management of gestational diabetes until birth Exclusion Criteria: * severe malformation that makes an examination impossible * existent of coagulation disorder with increased risk of bleeding after blood sampling
Where this trial is running
Tübingen
- University Hospital Tübingen — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Andreas Fritsche — University Hospital Tübingen
- Study coordinator: Louise Fritsche, Dr. rer. nat.
- Email: louise.fritsche@med.uni-tuebingen.de
- Phone: 07071-2980687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.