Type 2 Diabetes Clinical Trial
Official title:
Improvement in Glucose Control With Hydroxychloroquine in Type 2 Diabetes During Pregnancy: A Randomised Controlled 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
Status | Recruiting |
Enrollment | 56 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Antenatal clinic, UKM Medical Centre | Cheras | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
National University of Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the serum glycated haemoglobin between the two groups | Serum level of glycated haemoglobin in percentage | From Day 1 up to 38 weeks of gestation | |
Primary | To compare the serum fructosamine between the two groups | Serum level of fructosamine in nanogram per milliliter | From Day 1 up to 38 weeks of gestation | |
Primary | To compare the serum interleukin-6 between the two groups | Serum level of interleukin-6 in nanogram per milliliter | From Day 1 up to 38 weeks of gestation | |
Primary | To compare the serum interleukin-10 between the two groups | Serum level of interleukin-10 in nanogram per milliliter | From Day 1 up to 38 weeks of gestation | |
Primary | To compare the serum tumour necrosis factor alpha between the two groups | Serum level of tumour necrosis factor alpha in nanogram per milliliter | From Day 1 up to 38 weeks of gestation | |
Primary | To compare the shearwave elastography of the placenta between the two groups | Ultrasonography of shearwave of placenta measured in centimetres | From 32 until 36 weeks of gestation | |
Secondary | To compare the gestational age at delivery between the two groups | Gestational age at delivery in weeks | From recruitment up to 38 weeks of gestation | |
Secondary | Type of labour | Onset of labour either spontaneous or induced | From Day 1 up to 38 weeks of gestation | |
Secondary | Mode of delivery | Method of patient being delivered either vaginal or caesarean section | From recruitment up to 38 weeks of gestation | |
Secondary | Postpartum haemorrhage | Total blood loss of more than 500 milliliters for vaginal delivery and 1000 milliliters for caesarean delivery | Immediately from delivery up to 42 days post delivery | |
Secondary | Third or fourth degree perineal tear | The number of patients of suffered third or fourth degree perineal tear | Immediately from delivery up to 24 hours | |
Secondary | Neonatal birth weight at delivery | Birth weight of the neonate in grams | At delivery up to 24 hours | |
Secondary | Large for gestational age or macrosomia | Neonatal birth weight of more than 95th percentile based on Fenton birth weight chart or 4000 grams | At delivery up to 24 hours | |
Secondary | Shoulder dystocia | Number of patient who experienced shoulder dystocia at delivery | At delivery up to 24 hours | |
Secondary | Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes | Number of neonates with Apgar score of less than 7 at birth which is bad outcome | At delivery up to 10 minutes after delivery | |
Secondary | Arterial cord pH at birth | Number of neonates with arterial cord pH less than 7.25 at birth | At delivery up to 1 hour after delivery | |
Secondary | Number of neonates needing admission into neonatal intensive care unit | Admission of neonate into neonatal intensive care unit at birth | At delivery up to 7 days of life | |
Secondary | Height or length of neonates | Height or length of the neonates measured in centimetres | At birth, six and twelve months of age after delivery | |
Secondary | Weight of the neonates | Weight of the neonates measured in grams | At birth, six and twelve months of age after delivery | |
Secondary | Hospital admission | Numbers of neonates required hospital admission | From birth up to twelve months of age |
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