Clinical trial NCT06319560: Hydroxychloroquine in Type 2 Diabetes During Pregnancy
Official title: Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes in Pregnancy
Type 2 Diabetes
Keywords: diabetes
pregnancy
hydroxychloroquine
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 At recruitment, blood is withdrawn to measure glycated haemoglobin (HbA1c), full blood count, fructosamine, Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-alpha.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.

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

Primary outcomes:
measure: To compare the serum glycated haemoglobin (HbA1c) between the two groups
timeFrame: From Day 1 up to 38 weeks of gestation
measure: To compare the serum fructosamine between the two groups
timeFrame: From Day 1 up to 38 weeks of gestation
measure: To compare the serum interleukin-6 between the two groups
timeFrame: From Day 1 up to 38 weeks of gestation
measure: To compare the serum interleukin-10 between the two groups
timeFrame: From Day 1 up to 38 weeks of gestation
measure: To compare the serum tumour necrosis factor alpha between the two groups
timeFrame: From Day 1 up to 38 weeks of gestation
Secondary outcomes:
measure: To compare the gestational age at delivery between the two groups
timeFrame: From recruitment up to 38 weeks of gestation
measure: Type of labour
timeFrame: From recruitment up to 38 weeks of gestation
measure: Mode of delivery
timeFrame: From recruitment up to 38 weeks of gestation
measure: Postpartum haemorrhage
timeFrame: Immediately from delivery up to 42 days post delivery
measure: Obstetric anal sphincter injuries
timeFrame: Immediately from delivery up to 24 hours
measure: Neonatal birth weight at delivery
timeFrame: At delivery up to 24 hours
measure: Shoulder dystocia
timeFrame: At delivery up to 24 hours
measure: Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes
timeFrame: At delivery up to 10 minutes after delivery
measure: Number of neonates needing admission into neonatal intensive care unit
timeFrame: At delivery up to 7 days of life
measure: Height of the infant
timeFrame: At six and twelve months of age after delivery
measure: Weight of the infant
timeFrame: At six and twelve months of age after delivery
measure: Hospital admission
timeFrame: From day 7 of life up to twelve months of age
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Antenatal clinic, UKM Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: UKM
name: Rahana Abd Rahman
role: PRINCIPAL_INVESTIGATOR
References: