Conectar
Despite advances in maternity care, stillbirth remains a major burden. It disproportionately affects black and Asian mothers, those with obesity and women over the age of 35 years. Induction of labour may benefit these women, but there is no clear evidence to guide recommendations on optimal timing of induction because of variations in the intervention and insufficient power in primary trials for rare outcomes such as stillbirth and perinatal mortality, or to assess whether effects differ by maternal characteristics. We will conduct an individual participant data (IPD) meta-analysis of randomised trials to assess the overall and differential effect of induction of labour, according to timing of induction and maternal characteristics, on adverse perinatal and maternal outcomes. We will also rank induction of labour timing strategies by their effectiveness to inform clinical and policy decision-making.
We will identify randomised trials on induction of labour by searching MEDLINE, CINAHL, EMBASE, BIOSIS, LILACS, Pascal, SCI, CDSR, ClinicalTrials.gov, ICTRP, ISRCTN registry, CENTRAL, DARE and Health Technology Assessment Database, without language restrictions, from inception to June 2025. Primary researchers of identified trials will be invited to join the OPTIMAL Collaboration and share the original trial data. Data integrity and trustworthiness assessment will be performed on all eligible trials. We will check each study’s IPD for consistency with the original authors before standardising and harmonising the data. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool. We will perform a series of one-and-two-stage random-effects meta-analyses to obtain the summary intervention effect on composite adverse perinatal outcome (stillbirth, neonatal death or severe morbidity requiring admission to neonatal unit) with 95% CIs and summary treatment–covariate interactions (maternal age, ethnicity, parity, socioeconomic status, body mass index and method of conception). Heterogeneity will be summarised using tau2, I2 and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Small study effects (potential publication bias) will be investigated using funnel plots.
The study is registered on PROSPERO (CRD420251066346) and ethics approval is not required. We will disseminate findings widely to women, healthcare professionals and policymakers through academic, professional bodies and social media channels, and in peer-reviewed journals to achieve impact.
CRD420251066346.
Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?
This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.
This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.
This study examined the mental health literacy of perinatal healthcare professionals in the United Arab Emirates (UAE) and analysed how their knowledge, attitudes and confidence impact their clinical practices in addressing perinatal mental health disorders.
A qualitative study with a descriptive phenomenological design. Data were collected via semi-structured individual interviews and focus group discussions. The data were analysed inductively using Braun and Clarke’s six-step thematic analysis.
The study was conducted in Abu Dhabi, Dubai and Al Ain in the UAE. Participants were recruited from various healthcare facilities and professional educational events.
The participants consisted of perinatal healthcare professionals from seven disciplines, including lactation consultants, midwives, nurses, obstetricians, paediatricians, family medicine practitioners and psychiatrists/psychologists. All participants were required to be actively involved in providing care to perinatal patients and to have a minimum of one year of clinical experience. The study included three focus group discussions and 28 semistructured individual interviews, culminating in a sample of 43 participants for analysis.
Three key themes emerged: (1) Knowledge and awareness, highlighting variable understanding of perinatal mental health and reliance on instinct over formal screening; (2) Navigating professional roles and realities, showing empathy and willingness to support patients, yet role ambiguity, low confidence and societal stigma influence perinatal healthcare professionals’ responses and care practices and (3) Strengthening support systems and resources, where participants called for improved training, clear policies and psychosocial resources to overcome institutional and educational gaps and to enhance perinatal mental healthcare and patient outcomes.
The study reveals gaps in mental health literacy and institutional support that hinder the delivery of effective perinatal mental healthcare. Strengthening provider training, implementing standardised screening and referral pathways, and promoting culturally sensitive, multidisciplinary approaches are essential. Such interventions can enhance early detection and improve outcomes for mothers and infants. Further research should focus on developing and evaluating the efficacy of such interventions to enhance early detection and improve outcomes for mothers and infants.
Child-to-parent violence (CPV) has received limited attention in scientific literature, but due to a recent increase in reported cases, it has become a subject of investigation. The reliability and validity of the Child-to-Parent Violence Questionnaire (CPV-Q), in separate mother and father versions, have not yet been studied in Iran. This study aimed to assess the psychometric properties of the Persian CPV-Q.
This research employed a cross-sectional design to evaluate the Persian CPV-Q’s psychometric properties. The process included translation (using backward-forward method), face validity (via impact score calculation), content validity (using content validity ratio (CVR) and content validity index (CVI)), construct validity (through exploratory and confirmatory factor analyses (CFA)) and reliability assessment (via test–retest, coefficient α, coefficient and intraclass correlation coefficient (ICC)).
The study was conducted at the Faculties of Tabriz University of Medical Sciences.
A total of 500 qualified students from Tabriz University of Medical Sciences were recruited using cluster random sampling. These participants completed the Persian CPV-Q.
Face validity was confirmed, with impact scores exceeding 1.5 for all items. Content validity was strong, with CVR=0.92 and CVI=0.89. Exploratory factor analysis revealed four factors related to violence frequency and two factors regarding reasons for violence, consistent with the original questionnaire, covering 19 and 8 items, respectively. Total variance explained was 0.30 and 0.39 for the mother’s version and 0.33 and 0.43 for the father’s version in frequency and reason sections. The Kaiser-Meyer-Olkin test confirmed sample adequacy (
The Persian CPV-Q demonstrates adequate validity and reliability for assessing the prevalence and causes of CPV in Iranian society.
Maternal respiratory syncytial virus (RSV) vaccination has been introduced to protect infants from severe respiratory infections. However, its uptake and impact on perinatal outcomes are unknown in the UK.
To evaluate uptake of RSV vaccine during pregnancy in a UK population.
This cross-sectional study was conducted at a tertiary maternity hospital in London. The participants included pregnant women who delivered between 1 September and 17 December 2024 (n=1157). For the analysis of vaccine uptake, the cohort included women eligible for vaccination who delivered beyond 28 weeks’ gestation and were at 36 weeks or less on 1 September 2024 (n=911). The main outcome measures were RSV vaccine uptake and its association with sociodemographic factors, perinatal outcomes including preterm birth (PTB), hypertensive disorders of pregnancy and stillbirth.
Of 911 eligible women, 19% (n=173) received the RSV vaccine during pregnancy. Uptake increased significantly from 4% in September to 32% in December (p
RSV vaccine uptake shows significant increases over time, with disparities in uptake by ethnicity and socioeconomic status. Further research is needed to increase vaccination rates, particularly in disadvantaged groups, and evaluate perinatal outcomes.
Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.
A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.
This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.
To estimate the prevalence of established atherosclerotic cardiovascular disease (eASCVD) and the prevalence of ASCVD high-risk patients as defined by the European Society of Cardiology (ESC) among the Egyptian population of the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes (PACT)-Middle East and Africa study.
An observational, multicentre, cross-sectional study.
Eight secondary care centres in Egypt.
550 adult males and females who provided informed consent and had been diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days. Participants were excluded if they had participated previously in the study, had been diagnosed with T1DM, experienced mental incapacity, were unwilling to participate, had a known language barrier precluding adequate understanding or cooperation or had a known congenital heart disease or malformation.
The primary outcome was the proportion of patients with eASCVD, while the secondary outcome was the proportion of patients with T2D with high risk of ASCVD and without eASCVD.
Prevalence of eASCVD was 108/550 (19.6%, 95% CI 16.5% to 23.2%), and the prevalence of high risk for ASCVD in the population without eASCVD was 378/442 (85.5%, 95% CI 81.9% to 88.5%). Approximately 99% of the study population was categorised as ESC very high risk or high risk for CVD. On assessing utilisation of antidiabetic medications with cardiovascular benefit, only 20% were receiving sodium-glucose cotransporter-2 inhibitors, and 3% were receiving glucagon-like peptide-1 analogues.
The prevalence of eASCVD and high risk for ASCVD in Egypt is alarming, and the inadequate pharmacological control increases the ASCVD burden in the T2DM population. This calls for immediate, comprehensive action to reassess T2DM care.
There remains little consensus or guidelines for the clinical management of traumatic orbital fractures (OFx). The OFx Registry aims to increase real-world clinical evidence for the treatment of OFx via prospective, multicentre, international data collection. The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of surgical and non-surgical treatment of orbital floor and/or medial wall fractures.
Approximately 300 adult patients presenting with a displaced OFx in the orbital floor and/or medial wall will be enrolled prospectively over a recruitment period of ~36 months. All eligible patients treated either surgically or non-surgically as per routine standard of care will have follow-up assessments at 6 weeks, 3 months and 6 months post-treatment. Demographic data, injury details, treatment details and outcome measures will be documented in a cloud-based database. Outcome measures include clinical outcomes (eg, diplopia, extraocular motility, and condition of the eyelid, globe and soft tissues), radiological outcomes from collected images, patient-reported outcomes (eg, Diplopia Questionnaire and the newly developed AO Craniomaxillofacial (CMF) Injury Symptom Battery) and complications. A statistical analysis plan will be prepared before final analysis summarising the descriptive statistics to be used for data assessment. Appropriate research questions and statistical tests may be applied additionally, depending on the availability and quality of data collected.
Ethics approval was obtained before patients were enrolled at each participating site. Patient enrolment followed an informed consent process approved by the responsible ethics committee. Peer-reviewed publications are planned to disseminate the study results.
In moderate to high-risk surgical procedures, 15–25% of patients develop a postoperative surgical site infection. Intraoperative incisional wound irrigation has the potential to reduce surgical site infections, and additional randomised controlled trials are required to provide evidence of effectiveness.
This protocol describes a pragmatic, adaptive, participant and adjudicator-blinded trial at 13 sites in Canada in up to 2500 participants. Participants planned for surgery with an abdominal or groin incision, who are eligible and provide verbal consent through an integrated consent model, are randomised to receive intraoperative incisional wound irrigation with povidone-iodine, saline or no irrigation. The primary outcome is surgical site infection within 30 days postoperatively. Secondary outcomes include quality of life measured 30 days postoperatively and morbidity, mortality and healthcare utilisation within 90 days postoperatively.
This trial has been approved by the research ethics board at the participating centres and stopped enrolling participants on May 23, 2025. All participants will provide verbal consent. Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov.
The study is registered with http://clinicaltrial.gov (
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