Using hydroxychloroquine to improve pregnancy outcomes in women with Type 2 diabetes
Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy: A Randomised Controlled Trial
NA · National University of Malaysia · NCT06319560
This study is testing if adding hydroxychloroquine to the usual treatment can help pregnant women with Type 2 diabetes have better pregnancy outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | National University of Malaysia (other) |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT06319560 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of hydroxychloroquine as an additional treatment for pregnant women diagnosed with Type 2 diabetes. Participants will be randomly assigned to either a control group receiving standard treatment or an intervention group receiving hydroxychloroquine alongside standard care. The study will measure various outcomes, including pregnancy results and inflammatory markers, through blood tests and regular monitoring of blood glucose levels. Follow-up will include fetal growth assessments via ultrasound and regular consultations with a specialized care team.
Who should consider this trial
Good fit: Ideal candidates are singleton pregnant women diagnosed with Type 2 diabetes mellitus between 14-20 weeks of gestation.
Not a fit: Patients with autoimmune diseases, chronic kidney disease, fetal anomalies, or those on steroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy outcomes for women with Type 2 diabetes.
How similar studies have performed: While the use of hydroxychloroquine in pregnancy is being explored, this specific approach in Type 2 diabetes is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton * Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus Exclusion Criteria: * autoimmune disease such as Systemic Lupus Erythematosus or rheumatic disease * chronic kidney disease * fetal anomaly * women on steroid therapy * diabetic retinopathy * known thalassaemia or thalassaemia carrier
Where this trial is running
Cheras, Kuala Lumpur
- Antenatal clinic, UKM Medical Centre — Cheras, Kuala Lumpur, Malaysia (RECRUITING)
Study contacts
- Principal investigator: Rahana Abd Rahman — UKM
- Study coordinator: Rahana Abdul Rahman, MD
- Email: drrahana@ukm.edu.my
- Phone: 039145
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.
Conditions: Diabetes in Pregnancy, Type 2 Diabetes, diabetes, pregnancy, hydroxychloroquine