Empowering patients to manage gestational diabetes
Outcome of "Patient Empowerment" in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial
This study is testing a new approach that helps women with gestational diabetes learn to manage their condition better, compared to regular treatment, to see if it leads to healthier outcomes for both mothers and babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 388 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Public Health Foundation of Bangladesh Academic / other |
| Locations | 3 sites (Dhaka and 2 other locations) |
| Trial ID | NCT06277258 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a 'Patient Empowerment' model in managing Gestational Diabetes Mellitus (GDM) compared to conventional treatment methods. Conducted in four health centers in Dhaka, Bangladesh, the study will recruit women diagnosed with GDM and randomly assign them to either the empowerment intervention or standard care. The primary focus is on achieving better glycemic control and improving maternal and neonatal outcomes through education and self-management strategies. Participants will receive educational materials and support to help them monitor their blood sugar levels and adhere to dietary guidelines.
Who should consider this trial
Good fit: Ideal candidates are pregnant women between 18 to 36 weeks gestation who have been screened positive for GDM and have not previously managed their diabetes.
Not a fit: Patients with a known history of diabetes prior to pregnancy or those carrying twins or multiples may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved health outcomes for mothers and their babies during pregnancy.
How similar studies have performed: Previous studies have shown that patient empowerment strategies can improve diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Screen positive GDM cases, who have not been managed for diabetes by any means 2. Gestational age from18 weeks to 36 weeks Exclusion Criteria: 1. Known history of diabetes before pregnancy 2. Women with twin or multiple pregnancies
Where this trial is running
Dhaka and 2 other locations
- Azimpur Maternity hospital ( MCHTI) — Dhaka, Bangladesh (Recruiting)
- Shaheed Suhrawardy Medical College (ShSMC) — Dhaka, Bangladesh (Recruiting)
- Bangabandhu Sheikh Mujib Medical University (BSMMU) — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Tabassum Parveen, FCPS — Professor, Department of Fetomaternal Medicine, BSMMU
- Study coordinator: Tabassum Parveen, FCPS
- Email: drtparveen@gmail.com
- Phone: +8801911348808
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.