Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 11:30 AM
Study NCT ID:
NCT06319560
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine in Type 2 Diabetes During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the serum glycated haemoglobin (HbA1c) between the two groups', 'timeFrame': 'From Day 1 up to 38 weeks of gestation', 'description': 'Serum level of glycated haemoglobin (HbA1c) in percentage'}, {'measure': 'To compare the serum fructosamine between the two groups', 'timeFrame': 'From Day 1 up to 38 weeks of gestation', 'description': 'Serum level of fructosamine in nanogram per milliliter'}, {'measure': 'To compare the serum interleukin-6 between the two groups', 'timeFrame': 'From Day 1 up to 38 weeks of gestation', 'description': 'Serum level of interleukin-6 in nanogram per milliliter'}, {'measure': 'To compare the serum interleukin-10 between the two groups', 'timeFrame': 'From Day 1 up to 38 weeks of gestation', 'description': 'Serum level of interleukin-10 in nanogram per milliliter'}, {'measure': 'To compare the serum tumour necrosis factor alpha between the two groups', 'timeFrame': 'From Day 1 up to 38 weeks of gestation', 'description': 'Serum level of tumour necrosis factor alpha in nanogram per milliliter'}], 'secondaryOutcomes': [{'measure': 'To compare the gestational age at delivery between the two groups', 'timeFrame': 'From recruitment up to 38 weeks of gestation', 'description': 'Gestational age at delivery in weeks'}, {'measure': 'Type of labour', 'timeFrame': 'From recruitment up to 38 weeks of gestation', 'description': 'Onset of labour either spontaneous or induced'}, {'measure': 'Mode of delivery', 'timeFrame': 'From recruitment up to 38 weeks of gestation', 'description': 'Method of patient being delivered either vaginal or caesarean section'}, {'measure': 'Postpartum haemorrhage', 'timeFrame': 'Immediately from delivery up to 42 days post delivery', 'description': 'Total blood loss of more than 500 milliliters for vaginal delivery and 1000 milliliters for caesarean delivery'}, {'measure': 'Obstetric anal sphincter injuries', 'timeFrame': 'Immediately from delivery up to 24 hours', 'description': 'The number of patients who suffered third or fourth degree perineal tear'}, {'measure': 'Neonatal birth weight at delivery', 'timeFrame': 'At delivery up to 24 hours', 'description': 'Birth weight of the neonate in grams, Neonatal birth weight of more than 90th percentile based on Fenton birth weight chart will be considered as large for gestational age or more than 4000 grams will be considered as macrosomia'}, {'measure': 'Shoulder dystocia', 'timeFrame': 'At delivery up to 24 hours', 'description': 'Number of patient who experienced shoulder dystocia at delivery'}, {'measure': 'Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes', 'timeFrame': 'At delivery up to 10 minutes after delivery', 'description': 'Number of neonates with Apgar score of less than 7 at birth which is bad outcome'}, {'measure': 'Number of neonates needing admission into neonatal intensive care unit', 'timeFrame': 'At delivery up to 7 days of life', 'description': 'Admission of neonate into neonatal intensive care unit at birth'}, {'measure': 'Height of the infant', 'timeFrame': 'At six and twelve months of age after delivery', 'description': 'Height or length of the infant measured in centimetres'}, {'measure': 'Weight of the infant', 'timeFrame': 'At six and twelve months of age after delivery', 'description': 'Weight of the infant measured in grams'}, {'measure': 'Hospital admission', 'timeFrame': 'From day 7 of life up to twelve months of age', 'description': 'Numbers of infants required hospital admission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'pregnancy', 'hydroxychloroquine'], 'conditions': ['Diabetes in Pregnancy', 'Type 2 Diabetes']}, '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.\n\nThe main questions it aims to answer are:\n\n* Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy?\n* 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', 'detailedDescription': "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.\n\nAll 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.\n\nCompliance 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton\n* Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus\n\nExclusion Criteria:\n\n* autoimmune disease such as Systemic Lupus Erythematosus or rheumatic disease\n* chronic kidney disease\n* fetal anomaly\n* women on steroid therapy\n* diabetic retinopathy\n* known thalassaemia or thalassaemia carrier'}, 'identificationModule': {'nctId': 'NCT06319560', 'briefTitle': 'Hydroxychloroquine in Type 2 Diabetes During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'JEP-2023-866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine group', 'description': 'Oral hydroxychloroquine 200mg daily will be prescribed to women in this group from recruitment (14-20 weeks) till delivery, in addition to their standard treatment', 'interventionNames': ['Drug: Hydroxychloroquine Oral Tablet']}, {'type': 'NO_INTERVENTION', 'label': 'Standard treatment group', 'description': 'Women will receive standard treatment for diabetes such as metformin and insulin.'}], 'interventions': [{'name': 'Hydroxychloroquine Oral Tablet', 'type': 'DRUG', 'otherNames': ['plaquenil'], 'description': '200mg daily', 'armGroupLabels': ['Hydroxychloroquine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Cheras', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Rahana Abd Rahman', 'role': 'CONTACT'}], 'facility': 'Antenatal clinic, UKM Medical Centre'}], 'centralContacts': [{'name': 'Rahana Abdul Rahman, MD', 'role': 'CONTACT', 'email': 'drrahana@ukm.edu.my', 'phone': '039145', 'phoneExt': '5964'}], 'overallOfficials': [{'name': 'Rahana Abd Rahman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}