protocolSection identificationModule nctId: NCT06319560, orgStudyIdInfo id: JEP-2023-866, briefTitle: Hydroxychloroquine in Type 2 Diabetes During Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Diabetes in Pregnancy, conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Hydroxychloroquine Oral Tablet, outcomesModule primaryOutcomes measure: To compare the serum glycated haemoglobin between the two groups, primaryOutcomes measure: To compare the serum fructosamine between the two groups, primaryOutcomes measure: To compare the serum interleukin-6 between the two groups, primaryOutcomes measure: To compare the serum interleukin-10 between the two groups, primaryOutcomes measure: To compare the serum tumour necrosis factor alpha between the two groups, primaryOutcomes measure: To compare the shearwave elastography of the placenta between the two groups, secondaryOutcomes measure: To compare the gestational age at delivery between the two groups, secondaryOutcomes measure: Type of labour, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Postpartum haemorrhage, secondaryOutcomes measure: Third or fourth degree perineal tear, secondaryOutcomes measure: Neonatal birth weight at delivery, secondaryOutcomes measure: Large for gestational age or macrosomia, secondaryOutcomes measure: Shoulder dystocia, secondaryOutcomes measure: Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes, secondaryOutcomes measure: Arterial cord pH at birth, secondaryOutcomes measure: Number of neonates needing admission into neonatal intensive care unit, secondaryOutcomes measure: Height or length of neonates, secondaryOutcomes measure: Weight of the neonates, secondaryOutcomes measure: Hospital admission, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Antenatal clinic, UKM Medical Centre, status: RECRUITING, city: Cheras, state: Kuala Lumpur, zip: 56000, country: Malaysia, contacts name: Rahana Abd Rahman, role: CONTACT, geoPoint lat: 3.05, lon: 101.76667, hasResults: False