Hydroxychloroquine in Type 2 Diabetes During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorNational University of Malaysia
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton
Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus
Disqualifiers
autoimmune disease such as Systemic Lupus Erythematosus or rheumatic disease
chronic kidney disease
fetal anomaly
women on steroid therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Hydroxychloroquine Oral Tablet
Drug200mg daily
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Hydroxychloroquine groupExperimental treatment 1 intervention
Group B: Standard treatment groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To compare the serum glycated haemoglobin (HbA1c) between the two groups
Serum level of glycated haemoglobin (HbA1c) in percentage
Time frame
From Day 1 up to 38 weeks of gestation2
To compare the serum fructosamine between the two groups
Serum level of fructosamine in nanogram per milliliter
Time frame
From Day 1 up to 38 weeks of gestation3
To compare the serum interleukin-6 between the two groups
Serum level of interleukin-6 in nanogram per milliliter
Time frame
From Day 1 up to 38 weeks of gestation4
To compare the serum interleukin-10 between the two groups
Serum level of interleukin-10 in nanogram per milliliter
Time frame
From Day 1 up to 38 weeks of gestationSecondary outcomes
1
To compare the gestational age at delivery between the two groups
Gestational age at delivery in weeks
Time frame
From recruitment up to 38 weeks of gestation2
Type of labour
Onset of labour either spontaneous or induced
Time frame
From recruitment up to 38 weeks of gestation3
Mode of delivery
Method of patient being delivered either vaginal or caesarean section
Time frame
From recruitment up to 38 weeks of gestation4
Postpartum haemorrhage
Total blood loss of more than 500 milliliters for vaginal delivery and 1000 milliliters for caesarean delivery
Time frame
Immediately from delivery up to 42 days post deliveryLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Antenatal clinic, UKM Medical CentreRecruiting56000, Cheras, Kuala Lumpur
Malaysia
MalaysiaSponsors and contacts
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Source ClinicalTrials.gov