Observing gestational diabetes in pregnant women
German Study Gestational Diabetes (PREG)
This study looks at how common gestational diabetes is in pregnant women and what factors may increase the risk, aiming to improve care for moms and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT04270578 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor and understand the prevalence and implications of gestational diabetes mellitus (GDM) among pregnant women. It focuses on identifying risk factors such as maternal age and weight gain during pregnancy, as well as the socio-economic consequences of diabetes. Participants will be enrolled during pregnancy or postpartum, provided they meet specific inclusion criteria. The study seeks to enhance early detection and management of GDM to improve health outcomes for mothers and their children.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women between 24 and 31 weeks of gestation who have a documented occurrence of GDM in a previous pregnancy.
Not a fit: Patients with pre-existing diabetes mellitus, significant renal impairment, or certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of gestational diabetes, reducing complications for mothers and infants.
How similar studies have performed: Other studies have shown success in managing gestational diabetes through early detection and lifestyle interventions, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Signed and dated informed consent Enrollment is possible during AND after gestation: * Baseline visit (pregnancy): gestational week 24+0 till 31+6 * Postpartum visits: documented occurence of GDM in previous pregnancy Exclusion Criteria: * Age \< 18years * Diabetes Mellitus Type 1 or Type 2 * GFR \< 60 ml/min/1,73 m2 * CRP \> 1 mg/dl * Increased levels of transaminases 2 fold above ULN * Preexisting cardiac conditions * Weight loss \> 10% within 6 months prior to inclusion * Psychiatric disorders * Chronic alcohol or substance abuse * Blood sugar increasing or decreasing drug therapy, e.g. steroids, antidiabetics, insulin * only postpartum visits: pregnancy or lactation
Where this trial is running
Tübingen
- University Hospital Tuebingen — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Andreas Fritsche, MD — University Hospital Tuebingen
- Study coordinator: Andreas Fritsche, MD
- Email: andreas.fritsche@med.uni-tuebingen.de
- Phone: +49 7071 29
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.