Hydroxychloroquine in Type 2 Diabetes During Pregnancy

NCT ID: NCT06319560

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-24
• Study Completion Date: 2027-01-01

Brief Summary

The goal of this clinical trial is to compare the use of hydroxychloroquine as an adjunct to the current treatment of pregnant women with Type 2 diabetes mellitus.

The main questions it aims to answer are:

• Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy?
• Does hydroxychloroquine improve the inflammatory markers in women with type 2 diabetes during pregnancy? Participants will be randomised into the intervention and control group. The control group will be on standard treatment where as the intervention group will receive hydroxychloroquine as an adjunct of standard treatment

Detailed Description

This is a randomised clinical trial comparing 2 groups i.e type 2 diabetes complicating pregnancies on standard treatment alone which comprises of oral hypoglycaemic agent with or without insulin and those with added hydroxychloroquine 200mg daily. They will be recruited within 14-20 weeks gestation. Randomisation will be done using computer software program. At recruitment, blood is withdrawn to measure glycated haemoglobin (HbA1c), full blood count, fructosamine, Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-alpha. These investigations will be repeated before delivery. Patients will monitor their blood glucose using staggered 7 points which consisting of pre-meals and 1 hour post-meals using their own glucometer. The optimum fasting level is 4-5.3 mmol/l, pre meal and pre bed levels of 4-6 mmol/l and 1 hour post meal level of 4-7.8 mmol/l. All participants are followed up every 2-4 weekly whereby home blood glucose monitoring will be reviewed. Fetal growth will be monitored via serial ultrasound and charted on the fetal growth chart. Patients' care will be done by the research team which consist of obstetrician, endocrinologist and diabetic educator. All patients will have eye assessment by the ophthalmologist prior to commencement of hydroxychloroquine.

All women will be delivered at 38 weeks or earlier if there are other concomitant problems such as fetal growth restriction or poorly controlled diabetes via induction of labour. The details of the delivery for both mother and neonates will be documented. At birth, the offsprings will be seen by the neonatologist who is also in the research team. After delivery, participants will be followed up in research clinic at 6 and 12 months together with the neonate. The height and weight of the infants will be measured in centimeter. Developmental milestones will be assessed according to the developmental milestones chart of Paediatric Protocols for Malaysian Hospitals 4th Edition 2019.

Compliance to hydroxychloroquine will be assessed at each follow up, whereby an indirect method of assessing adherence of participants in the hydroxychloroquine group will be made. Each participant will be asked whether they are still taking the study medication and are required to bring the remaining medication for tablet count. Participants with remaining of more than 20% of the scheduled medications will be considered as non-compliance and treated as drop-out. Participants will also be considered as drop-out when they are lost to follow-up, withdrawal of consent, non-compliance to hydroxychloroquine or a patient becomes ill due to drug adverse effects.

Conditions

Diabetes in Pregnancy; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydroxychloroquine group

Oral hydroxychloroquine 200mg daily will be prescribed to women in this group from recruitment (14-20 weeks) till delivery, in addition to their standard treatment

Group Type: EXPERIMENTAL

Hydroxychloroquine Oral Tablet

Intervention Type: DRUG

200mg daily

Standard treatment group

Women will receive standard treatment for diabetes such as metformin and insulin.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hydroxychloroquine Oral Tablet

200mg daily

Intervention Type: DRUG

Other Intervention Names

plaquenil

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rahana Abd Rahman

Role: PRINCIPAL_INVESTIGATOR

UKM

Locations

Antenatal clinic, UKM Medical Centre

Cheras, Kuala Lumpur, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Rahana Abdul Rahman, MD

Role: CONTACT

drrahana@ukm.edu.my

039145 ext. 5964

Facility Contacts

Rahana Abd Rahman

Role: primary

Other Identifiers

JEP-2023-866

Identifier Type: -

Identifier Source: org_study_id