Preventing postpartum diabetes in women with gestational diabetes
Gestational Diabetes - A Randomized, Controlled Trial PrEvention of PostPartum Diabetes Study (the PEPP Diabetes Study)
This study is testing whether special support and encouragement can help women who had gestational diabetes avoid developing type 2 diabetes after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Skövde) |
| Trial ID | NCT05112588 on ClinicalTrials.gov |
What this trial studies
This study focuses on women diagnosed with gestational diabetes, aiming to prevent the development of type 2 diabetes postpartum. It involves a randomized clinical approach where participants will receive interventions designed to promote physical activity and adherence to follow-up care. The study addresses the challenges faced by women post-delivery, including the lack of compliance with glucose tolerance testing and follow-up recommendations. By implementing new diagnostic criteria and support systems, the study seeks to improve health outcomes for both mothers and their children.
Who should consider this trial
Good fit: Ideal candidates for this study are women who have been diagnosed with gestational diabetes and are willing to participate in follow-up care.
Not a fit: Patients with pre-existing diabetes or other endocrine disorders that affect blood glucose control may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of type 2 diabetes in women who have experienced gestational diabetes.
How similar studies have performed: Other studies have shown success in similar approaches to managing gestational diabetes and preventing postpartum diabetes, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational diabetes * Signed "Informed consent" * Will be expected to participate in ordinary child health care. * Access to Internet via computer, pad or phone Exclusion Criteria: * Manifest diabetes mellitus before pregnancy. * Other conditions, e.g. endocrine disorders, or treatment, e.g. cortisone medication, that could affect blood glucose control * Suspicion of type 1 diabetes mellitus as assessed by GAD antibodies or clinical history * Participation in other concomitant research study that could interfere with the study parameters * Other disease, treatment or condition that according to the Principal Investigator precludes participation
Where this trial is running
Skövde
- Maternity Ward, Västra Götaland — Skövde, Sweden (Recruiting)
Study contacts
- Principal investigator: Margareta MI Hellgren — Vastra Gotaland
- Study coordinator: Margareta I Hellgren
- Email: margareta.leonardsson-hellgren@vgregion.se
- Phone: +46708381612
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.