Diabetes in PregnancyNCT06319560
Hydroxychloroquine in Type 2 Diabetes During Pregnancy
A study testing Hydroxychloroquine Oral Tablet in people with Diabetes in Pregnancy and Type 2 Diabetes, run by National University of Malaysia at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Diabetes in Pregnancy, Type 2 Diabetes
- What is being tested?
- Hydroxychloroquine Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- 24 Mar 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton
- Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus
Who cannot join
- autoimmune disease such as Systemic Lupus Erythematosus or rheumatic disease
- chronic kidney disease
- fetal anomaly
- women on steroid therapy
- diabetic retinopathy
- known thalassaemia or thalassaemia carrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Antenatal clinic, UKM Medical Centre
Cheras, Kuala Lumpur, 56000
Rahana Abd Rahman
About this study
Official title: Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in 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
Read the detailed 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 (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.
All 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.
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.
- Conditions
- Diabetes in Pregnancy, Type 2 Diabetes
- Being tested
- Hydroxychloroquine Oral Tablet
- Keywords
- diabetes, pregnancy, hydroxychloroquine
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Oral TabletDrug
Also called plaquenil
200mg daily
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine group | Experimental | 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 Receives: Drug: Hydroxychloroquine Oral Tablet |
| Standard treatment group | No intervention | Women will receive standard treatment for diabetes such as metformin and insulin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the serum glycated haemoglobin (HbA1c) between the two groups
Serum level of glycated haemoglobin (HbA1c) in percentage
Measured: From Day 1 up to 38 weeks of gestation
To compare the serum fructosamine between the two groups
Serum level of fructosamine in nanogram per milliliter
Measured: From Day 1 up to 38 weeks of gestation
To compare the serum interleukin-6 between the two groups
Serum level of interleukin-6 in nanogram per milliliter
Measured: From Day 1 up to 38 weeks of gestation
To compare the serum interleukin-10 between the two groups
Serum level of interleukin-10 in nanogram per milliliter
Measured: From Day 1 up to 38 weeks of gestation
To compare the serum tumour necrosis factor alpha between the two groups
Serum level of tumour necrosis factor alpha in nanogram per milliliter
Measured: From Day 1 up to 38 weeks of gestation
Secondary outcomes (12)
To compare the gestational age at delivery between the two groups
Gestational age at delivery in weeks
Measured: From recruitment up to 38 weeks of gestation
Type of labour
Onset of labour either spontaneous or induced
Measured: From recruitment up to 38 weeks of gestation
Mode of delivery
Method of patient being delivered either vaginal or caesarean section
Measured: From recruitment up to 38 weeks of gestation
Postpartum haemorrhage
Total blood loss of more than 500 milliliters for vaginal delivery and 1000 milliliters for caesarean delivery
Measured: Immediately from delivery up to 42 days post delivery
Obstetric anal sphincter injuries
The number of patients who suffered third or fourth degree perineal tear
Measured: Immediately from delivery up to 24 hours
Neonatal birth weight at delivery
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
Measured: At delivery up to 24 hours
Shoulder dystocia
Number of patient who experienced shoulder dystocia at delivery
Measured: At delivery up to 24 hours
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
Measured: At delivery up to 10 minutes after delivery
Number of neonates needing admission into neonatal intensive care unit
Admission of neonate into neonatal intensive care unit at birth
Measured: At delivery up to 7 days of life
Height of the infant
Height or length of the infant measured in centimetres
Measured: At six and twelve months of age after delivery
Weight of the infant
Weight of the infant measured in grams
Measured: At six and twelve months of age after delivery
Hospital admission
Numbers of infants required hospital admission
Measured: From day 7 of life up to twelve months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start24 Mar 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahana Abd Rahman, Principal investigator, UKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319560
- Sponsor's protocol ID
- JEP-2023-866
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basri NI, A Wahab N, Mohammed Nawi A, Ishak S, Murthi P, Abd Rahman R. Hydroxychloroquine as an adjunct therapy in the management of type 2 diabetes in pregnancy: study protocol for a randomised controlled trial. BMJ Open. 2026 Jan 20;16(1):e106653. doi: 10.1136/bmjopen-2025-106653.
PubMed 41558753
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06319560
- Acronym / sponsor ID
- JEP-2023-866
- Conditions
- Diabetes in Pregnancy, Type 2 Diabetes
- Keywords
- diabetes, pregnancy, hydroxychloroquine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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 (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.
All 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine group | Experimental | Drug: Hydroxychloroquine Oral TabletOral hydroxychloroquine 200mg daily will be prescribed to women in this group from recruitment (14-20 weeks) till delivery, in addition to their standard treatment |
| Standard treatment group | No intervention | –Women will receive standard treatment for diabetes such as metformin and insulin. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton
- Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus
Key exclusion criteria (6 listed)
- autoimmune disease such as Systemic Lupus Erythematosus or rheumatic disease
- chronic kidney disease
- fetal anomaly
- women on steroid therapy
- diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Oral TabletAlso: plaquenil200mg daily | Drug | Hydroxychloroquine group |
Primary outcome
To compare the serum glycated haemoglobin (HbA1c) between the two groups
Time frame: From Day 1 up to 38 weeks of gestation
Serum level of glycated haemoglobin (HbA1c) in percentage
To compare the serum fructosamine between the two groups
Time frame: From Day 1 up to 38 weeks of gestation
Serum level of fructosamine in nanogram per milliliter
To compare the serum interleukin-6 between the two groups
Time frame: From Day 1 up to 38 weeks of gestation
Serum level of interleukin-6 in nanogram per milliliter
To compare the serum interleukin-10 between the two groups
Time frame: From Day 1 up to 38 weeks of gestation
Serum level of interleukin-10 in nanogram per milliliter
To compare the serum tumour necrosis factor alpha between the two groups
Time frame: From Day 1 up to 38 weeks of gestation
Serum level of tumour necrosis factor alpha in nanogram per milliliter
12 secondary outcomes
To compare the gestational age at delivery between the two groups
Time frame: From recruitment up to 38 weeks of gestation
Type of labour
Time frame: From recruitment up to 38 weeks of gestation
Mode of delivery
Time frame: From recruitment up to 38 weeks of gestation
Postpartum haemorrhage
Time frame: Immediately from delivery up to 42 days post delivery
Obstetric anal sphincter injuries
Time frame: Immediately from delivery up to 24 hours
Neonatal birth weight at delivery
Time frame: At delivery up to 24 hours
Shoulder dystocia
Time frame: At delivery up to 24 hours
Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes
Time frame: At delivery up to 10 minutes after delivery
Number of neonates needing admission into neonatal intensive care unit
Time frame: At delivery up to 7 days of life
Height of the infant
Time frame: At six and twelve months of age after delivery
Weight of the infant
Time frame: At six and twelve months of age after delivery
Hospital admission
Time frame: From day 7 of life up to twelve months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 41558753Basri NI, A Wahab N, Mohammed Nawi A, Ishak S, Murthi P, Abd Rahman R. Hydroxychloroquine as an adjunct therapy in the management of type 2 diabetes in pregnancy: study protocol for a randomised controlled trial. BMJ Open. 2026 Jan 20;16(1):e106653. doi: 10.1136/bmjopen-2025-106653.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahana Abd Rahman principal investigator
UKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine Oral Tablet in people with Diabetes in Pregnancy and Type 2 Diabetes, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahana Abdul Rahman, MD (039145 ext. 5964, drrahana@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the serum glycated haemoglobin (HbA1c) between the two groups (time frame: From Day 1 up to 38 weeks of gestation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06319560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.