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

Por: Basri · N. I. · A Wahab · N. · Mohammed Nawi · A. · Ishak · S. · Murthi · P. · Abd Rahman · R.
Introduction

The 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.

Protocol for a systematic review and meta-analysis of the impact of cervical cancer prevention initiatives in Ghana

by Emmanuel Timmy Donkoh, Iddrisu Wahab Abdul, Abraham Kwadzo Ahiakpa, Isaac Williams, Rita Nyaaba Akologo, Stephen Danyo, Chrysantus Kubio, Kofi Effah, Joseph Emmanuel Amuah

Background

Cervical cancer, though preventable, remains the second most diagnosed cancer and the primary cause of cancer-related deaths among females in Sub-Saharan Africa. The significance of coordinated screening programmes for reducing the burden of cervical cancer in Africa is not well documented. This systematic review will summarize published reports from key databases, grey literature and programme reports to assess the performance of cervical cancer prevention programmes in Ghana.

Methods

To be eligible for inclusion, interventions must target Ghanaian women with cervical cancer screening and prevention strategies using methods such as visual inspection with acetic acid (VIA), mobile colposcopy, HPV DNA testing, cytology (Pap smear), and treatment approaches such as cryotherapy, thermal ablation, loop electrosurgical excision procedure (LEEP). A comprehensive electronic search strategy will be used to identify studies published since database inception, and indexed in MEDLINE, EMBASE, CINAHL and Web of Science. The search strategy will include MeSH terms (and synonyms) relevant to cervical cancer, screening/treatment methods, geographic focus and implementing institution. We will include searches for grey literature, recognizing the value of programmatic and governmental reports that might not appear in traditional databases. Search results will be summarized in line with PRISMA guidelines. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach will be used to evaluate and document evidence certainty for all outcomes, internal validity of included reports, inconsistency, indirectness, imprecision, and publication bias. Where sufficient homogeneity exists among included studies in terms of interventions, study designs, populations, and outcome measures, we will perform a meta-analysis to calculate pooled effect estimates and their corresponding 95% confidence intervals.

Significance

This systematic review will assess the performance and impact of cervical cancer screening and prevention programmes conducted in Ghana to date and identify what contextual strategies have delivered the most impact as well as highlight what gaps remain in our understanding of how a nationwide screening programme can be properly construed for maximum impact.

The Climate‐Asthma Connection: Examining the Influence of Climate Change Anxiety on Asthma Control and Quality of Life: A Multi‐National Study

ABSTRACT

Aims

This study aims to identify the impact of climate change anxiety and asthma control on asthmatics' quality of life and examine the moderating role of climate change anxiety in this linkage.

Method

A multi-national cross-sectional study was conducted in four Arabian countries on 1266 asthmatics selected by convenience sampling. Data were collected from November 2023 to February 2024 using a climate anxiety scale, mini-asthma quality of life questionnaire, and an asthma control questionnaire.

Results

Climate anxiety was higher among middle-aged participants, as well as those with longer disease durations and previous hospitalisations. Climate anxiety showed strong negative correlations with asthma control (r = −0.704, p ≤ 0.05) and asthma quality of life (r = − 0.638, p ≤ 0.05). Climate anxiety and asthma control are powerful predictors of quality of life among asthmatics. Climate anxiety moderates the relationship between asthma control and quality of life, making it less positive (B = −0.094, p > 0.001). Covariates such as gender, age, comorbidities, employment status, disease duration, and previous hospitalisation showed significant associations with asthma quality of life.

Implications for Nursing Practice

Assessment and mitigation of climate anxiety among asthmatics is a key strategy for controlling asthma and improving the quality of life. So, nurses must incorporate climate anxiety assessment into the care plan for asthmatics.

Impact

Climate change is a global concern, and insights into how climate-related psychological stressors exacerbate asthma symptoms and overall health outcomes are necessary. The findings provide actionable data for healthcare professionals to underscore the need for integrated healthcare approaches considering environmental and psychological factors.

Reporting Method

This study adheres to strengthening the reporting of observational studies in epidemiology (STROBE) statement.

Patient or Public Contribution

Clients with asthma across multiple nationalities actively contributed to our paper.

The Association between Emotional Responses to Climate Change, Antenatal Anxiety and Maternal–Fetal Attachment in Primigravida Women

ABSTRACT

Aim

To investigate the association between emotional responses to climate change, antenatal anxiety, and maternal–fetal attachment in primigravida women.

Design

A multi-site cross-sectional research design study.

Methods

This study was conducted at four primary health care (PHC) facilities in Damanhur district, El-Behera, from February 2024 to April 2024. Two hundred eighty-five women completed a comprehensive questionnaire that included a Woman's Social and Reproductive Form, The inventory of climate emotions (ICE) scale, The Stirling Antenatal Anxiety Scale (SAAS) and the Maternal–Fetal Attachment Scale (MFAS-HU-20).

Results

The study revealed that emotional responses to climate change show strong positive correlations with each other, ranging from 0.689 to 0.840, all significant at p < 0.001 level. Additionally, antenatal anxiety demonstrates substantial positive correlations with emotional responses to climate change, albeit with associations ranging from 0.239 to 0.287, all significant at p < 0.001 level. Moreover, maternal–fetal attachment displays substantial negative correlations with emotional responses to climate change, indicating that as emotional responses to climate change increase, maternal–fetal attachment tends to decrease. The correlations range from −0.263 to −0.426, all significant at p < 0.001.

Conclusions

The emotional impact of climate change can adversely affect the bonding process between mother and fetus.

Implications for the Profession

Healthcare professionals, including obstetricians, midwives, and mental health counsellors, should integrate climate-related emotional distress into their assessments and interventions. Providing targeted psychological support for expectant mothers.

Impact

The study's findings highlight the need for nursing to integrate climate-related emotional distress screening into prenatal care and for research to explore long-term effects and intervention effectiveness. In practice, healthcare providers should adopt holistic approaches that combine environmental and psychological support, developing comprehensive guidelines and community-based programs to support pregnant women.

Reporting Method

The research adhered to that is STROBE.

Patient or Public Contribution

Public contributions by women in community health centers.

Postnatal care utilisation and health beliefs among mothers in the Jazan region of Saudi Arabia: a cross-sectional study

Por: Altraifi · A. A. · Albasheer · O. · Abdelwahab · S. I. · Chourasia · U. · Abdelmageed · M. M. · Hakami · A. M. · Khormi · A. H. · Medani · I. E. · Ali · S. A. · Habeeb · S. A. · Shebaly · G. A. · Somaily · M. M. · Harshan · S. M. · Ali · S. M. · Hukma · S. H.
Background

The postnatal period is critical for preventing maternal and neonatal morbidity and mortality. Globally, a significant proportion of maternal and neonatal deaths occur within the first 6 weeks after delivery. Timely and adequate postnatal care (PNC) can detect and manage life-threatening complications; however, service utilisation remains alarmingly low in many low- and middle-income countries, including Saudi Arabia. Addressing the behavioural and perceptual factors that influence service use is essential for improving health outcomes.

Objectives

This study aimed to assess mothers’ utilisation of PNC services and examine how their health beliefs and sociodemographic characteristics influence this behaviour.

Design

A cross-sectional study guided by the Health Belief Model (HBM) was conducted to explore predictors of PNC utilisation.

Setting

Eight primary healthcare (PHC) centres were randomly selected from 179 PHC centres distributed in the different governorates of the Jazan region of Saudi Arabia.

Participants

A total of 464 mothers were surveyed between October and December 2023 using an interviewer-administered questionnaire.

Primary and secondary outcome measures

The primary outcome was PNC utilisation, defined by the number of postnatal visits. The independent variables included sociodemographic characteristics and HBM constructs (perceived susceptibility, benefits, barriers and cues to action).

Results

In terms of PNC utilisation, 80.0% of participants had two or fewer postnatal visits, whereas 20.0% had three or more postnatal visits. Perceived barriers had the strongest influence (mean score 2.51±0.87), followed by cues to action (2.43±0.89), susceptibility (1.92±0.72) and benefits (1.86±0.64). In the multivariate analysis, perceived barriers, cues to action and perceived susceptibility were significantly associated with PNC utilisation, with adjusted ORs of 1.679 (95% CI: 1.007 to 2.799), 0.470 (95% CI: 0.256 to 0.863) and 0.405 (95% CI: 0.197 to 0.832), respectively.

Conclusions

PNC utilisation in the Jazan region remains suboptimal. Perceptual factors, particularly barriers and cues to action, play a central role in service use. Health interventions targeting these beliefs and improving follow-up mechanisms may help increase PNC engagement and improve maternal and infant health outcomes in Saudi Arabia.

Protocol for the OPTIMSE-1 randomised clinical trial to test specialist-led identification and management of cardio-renal-metabolic-pulmonary disease in machine learning algorithm-detected high-risk community-dwelling individuals

Por: Nadarajah · R. · Wahab · A. · Joseph · T. · Reynolds · C. · Bennett · S. · Haris · M. · Smith · A. B. · Hayward · C. · Wu · J. · Gale · C. P.
Introduction

People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.

Methods and analysis

OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care. The primary endpoint is a composite of initiation or increase of guideline-directed CRMP therapies. The secondary endpoints are the components of the primary endpoint, time to primary endpoint, diagnosis of new CRMP diseases or risk factors, time to diagnosis of new CRMP diseases or risk factors, initiation or increase of guideline-directed CRMP therapies for participants with recorded CRMP disease, initiation or increase of guideline-directed CRMP therapies for participants with newly diagnosed CRMP disease and change in participant-reported quality of life.

Ethics and dissemination

The study has ethical approval (the North East & North Tyneside 2 Research Ethics Committee reference 24/NE/0188). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.

Trial registration number

Clinicaltrials.gov NCT06444711.

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