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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06319560
Other study ID # JEP-2023-866
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date January 1, 2027

Study information

Verified date May 2024
Source National University of Malaysia
Contact Rahana Abdul Rahman, MD
Phone 039145
Email drrahana@ukm.edu.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 At recruitment, blood is withdrawn to measure glycated haemoglobin, fructosamine, Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-alpha.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 consist of fasting, pre-lunch and dinner, 1 hour post breakfast, lunch and dinner and pre bed 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. Placental shear wave elastography will be performed within 32-36 weeks of gestation using ultrasound and the results are documented. All women will be delivered at 38 weeks or earlier if there are other concomitant problems such 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Hydroxychloroquine Oral Tablet
200mg daily

Locations

Country Name City State
Malaysia Antenatal clinic, UKM Medical Centre Cheras Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

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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