Using hydroxychloroquine to improve pregnancy outcomes in women with Type 2 diabetes
Official title: Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy: A Randomised Controlled Trial
Run by National University of Malaysia · NCT06319560 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 45 Years |
| Sex | Women only |
| Enrollment | 56 (estimated) |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Status | Recruiting |
| Started | March 24, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT06319560 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are singleton pregnant women diagnosed with Type 2 diabetes mellitus between 14-20 weeks of gestation.
✕Probably not a fit
Patients with autoimmune diseases, chronic kidney disease, fetal anomalies, or those on steroid therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.