Evidence map›Paper›PMID 41558753›Full record

ArticleBMJ open2026

Hydroxychloroquine as an adjunct therapy in the management of type 2 diabetes in pregnancy: study protocol for a randomised controlled trial.

Nurul Iftida Basri, Norasyikin A Wahab, Azmawati Mohammed Nawi, Shareena Ishak, Padma Murthi, Rahana Abd Rahman

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06319560 (Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06319560 narecruitingnot on this map

Hydroxychloroquine as an Adjunct Therapy in the Management of Type 2 Diabetes in Pregnancy: A Randomised Controlled Trial

TypeinterventionalSponsorNational University of MalaysiaRan2024 to 2027Enrolled56ConditionsDiabetes in Pregnancy, Type 2 DiabetesArmsHydroxychloroquine Oral Tablet
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Nurul Iftida BasriObstetrics & Gynaecology, National University of Malaysia Faculty of Medicine, Federal Territory of Kuala Lumpur, Malaysia.ORCID http://orcid.org/0000-0002-3430-0963
Norasyikin A WahabInternal Medicine, National University of Malaysia Faculty of Medicine, Federal Territory of Kuala Lumpur, Malaysia.ORCID http://orcid.org/0000-0002-1168-217X
Azmawati Mohammed NawiDepartment of Public Health Medicine, National University of Malaysia Faculty of Medicine, Federal Territory of Kuala Lumpur, Malaysia.
Shareena IshakPaediatric, National University of Malaysia Faculty of Medicine, Federal Territory of Kuala Lumpur, Malaysia.
Padma MurthiDepartment of Maternal-Fetal Medicine Pregnancy Research Centre, Faculty of Biosciences, Royal Women's Hospital, Victoria University, Melbourne, Victoria, Australia.
Rahana Abd RahmanDepartment of Obstetrics and Gynecology, National University of Malaysia Faculty of Medicine, Federal Territory of Kuala Lumpur, Malaysia drrahana@ukm.edu.my.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe increasing incidence of type 2 diabetes mellitus (T2DM) among women of reproductive age poses significant health risks for both mothers and their fetuses. Optimising blood glucose levels during pregnancy is particularly challenging, even with a combination of oral antidiabetic agents and insulin therapy. Hydroxychloroquine (HCQ) has been shown to lower glucose levels in non-pregnant populations and has demonstrated safety in pregnant women with systemic lupus erythematosus and rheumatoid diseases. In addition to its glucose-lowering effects, HCQ also exhibits immunomodulatory, antioxidant and anti-inflammatory properties. Given that both T2DM and pregnancy are pro-inflammatory states, inadequate glycaemic control may exacerbate adverse pregnancy outcomes. We hypothesise that adjunctive treatment with HCQ in this cohort could improve glycaemic control, reduce systemic inflammation and subsequently lower the risk of adverse pregnancy outcomes. METHODS AND ANALYSIS: This is a prospective, open-label, randomised controlled trial involving 56 pregnant women diagnosed with T2DM. Participants will be randomly allocated, using computerised randomisation software, into either a control group receiving standard care or an intervention group receiving standard care with HCQ 200 mg daily. The primary outcomes will be the difference in glycaemic parameters and inflammatory markers. Secondary outcomes include the assessment of pregnancy outcomes between the groups, such as gestational age at delivery, postpartum haemorrhage, fetal macrosomia and shoulder dystocia. ETHICS AND DISSEMINATION: This protocol has been approved by the National University of Malaysia Ethics Committee (JEP-2023-866). Study findings will be disseminated via presentations at academic conferences, publications in peer-reviewed journals and professional training and meetings to healthcare professionals. TRIAL REGISTRATION NUMBER: This study was registered in ClinicalTrials.gov (NCT06319560) on 23 January 2024.

Indexed as

Diabetes Mellitus, Type 2HydroxychloroquinePregnancy in DiabeticsAdultBlood GlucoseFemaleHumansHypoglycemic AgentsPregnancyPregnancy OutcomeProspective StudiesRandomized Controlled Trials as TopicBlood GlucoseHydroxychloroquineHypoglycemic AgentsDiabetes in pregnancyDiabetes Mellitus, Type 2Pregnancy

Identifiers

PMID41558753
PMCPMC12820818

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.