NCT06319560

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Mar 2024Jan 2027

First Submitted

Initial submission to the registry

January 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 24, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

January 23, 2024

Last Update Submit

June 9, 2025

Conditions

Diabetes in PregnancyType 2 Diabetes

Keywords

diabetespregnancyhydroxychloroquine

Outcome Measures

Primary Outcomes (5)

  • To compare the serum glycated haemoglobin (HbA1c) between the two groups

    Serum level of glycated haemoglobin (HbA1c) in percentage

    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

    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

    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

    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

    From Day 1 up to 38 weeks of gestation

Secondary Outcomes (12)

  • To compare the gestational age at delivery between the two groups

    From recruitment up to 38 weeks of gestation

  • Type of labour

    From recruitment up to 38 weeks of gestation

  • Mode of delivery

    From recruitment up to 38 weeks of gestation

  • Postpartum haemorrhage

    Immediately from delivery up to 42 days post delivery

  • Obstetric anal sphincter injuries

    Immediately from delivery up to 24 hours

  • +7 more secondary outcomes

Study Arms (2)

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

Drug: Hydroxychloroquine Oral Tablet

Standard treatment group

NO INTERVENTION

Women will receive standard treatment for diabetes such as metformin and insulin.

Interventions

Hydroxychloroquine Oral TabletDRUG

200mg daily

Also known as: plaquenil
Hydroxychloroquine group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton
  • Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antenatal clinic, UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41558753DERIVED

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rahana Abd Rahman

    UKM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahana Abdul Rahman, MD

CONTACT

039145drrahana@ukm.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

March 20, 2024

Study Start

March 24, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)