Countries face challenges in maternal and newborn care (MNC) regarding costs, workforce and sustainability. Organising integrated care is increasingly seen as a way to address these challenges. The evidence on the optimal organisation of integrated MNC in order to improve outcomes is limited.

(1) To study associations between organisational elements of integrated care and maternal and neonatal health outcomes, experiences of women and professionals, healthcare costs and care processes and (2) to examine how the different dimensions of integrated care, as defined by the Rainbow Model of Integrated Care, are reflected in the literature addressing these organisational elements.

We included 288 papers and identified 23 organisational elements, grouped into 6 categories: personal continuity of care; interventions to improve interdisciplinary collaboration and coordination; care by a midwife; alternative payment models (non-fee-for-service); place of birth outside the obstetric unit and woman-centred care. Personal continuity, care by a midwife and births outside obstetric units were most consistently associated with improved maternal and newborn outcomes, positive experiences for women and professionals and potential cost savings, particularly where well-coordinated multidisciplinary care was established. Positive professional experiences of collaboration depended on clear roles, mutual trust and respectful interdisciplinary behaviour. Evidence on collaboration interventions and alternative payment models was inconclusive. Most studies emphasised clinical and professional aspects rather than organisational integration, with implementation barriers linked to prevailing biomedical system orientations.

Although the literature provides substantial evidence of organisational elements that contribute to improved outcomes, a significant gap remains in understanding how to overcome the barriers in sustainable implementation of these elements within healthcare systems. Interpreted through a systems and transition science lens, these findings suggest that strengthening integrated maternity care requires system-level changes aligning with WHO policy directions towards midwifery models of person-centred care.

Although the WHO and the Centers for Disease Control and Prevention (CDC) classify preconception health risks (PCHRs) into biomedical, behavioural and social categories, this classification remains theoretical, mainly inconsistent and lacks a scientifically robust framework. Data-driven clustering techniques may help clarify this complexity for policymakers and healthcare providers. This study aimed to assess the status of PCHRs and identify latent classes of these risks among women preparing for pregnancy.

This community-based cross-sectional study was conducted from 31 July to 16 August 2024 in Tigray, Ethiopia, among 865 married women planning to conceive within the next 6 months. Data were gathered through face-to-face interviews using a structured questionnaire. Risk factor indicators covering lifestyle behaviours, substance use, nutritional risks and related factors were developed based on guidelines from the WHO, the CDC and national recommendations. Latent class analysis (LCA) was employed to identify distinct classes of PCHRs, with the optimal number of classes determined using statistical fit indices, adequacy criteria and interpretability. The study also evaluated the overall distribution of PCHRs among participants.

The study took place in Tigray, Ethiopia, among married women intending to become pregnant within 6 months.

Burden of PCHRs and identified distinct latent classes of these risks within the participants.

All participants were exposed to at least four PCHRs, with 84.2% experiencing between 6 and 12 risk factors. The optimal LCA model identified four distinct classes of PCHRs: lifestyle behavioural risks (n=458, 52.9%), reproductive health risks and chronic medical conditions (n=106, 12.25%), nutritional risks and environmental exposure (n=149, 17.23%) and social determinants of health (n=152, 17.57%).

Our study reveals a high baseline level of PCHRs, with all participants exhibiting multiple risk factors for adverse pregnancy outcomes. The identification of four distinct risk profiles underscores the need for tailored risk-specific interventions, particularly in conflict-affected settings. Our findings point out the need for targeted preconception care and risk stratification in national health strategies to improve maternal and child health outcomes.

Many pregnant women have a history of trauma, such as abuse or violence, which can significantly impact their mental and physical health. Discussing these experiences in maternity care presents an opportunity to support women, reduce stigma and connect them with resources. However, concerns persist about stigmatisation, re-traumatisation and unwarranted safeguarding referrals.

The objective of this study was to explore how trauma discussions should be approached in maternity care, drawing on the perspectives of women with lived experience, voluntary sector representatives and healthcare providers in the UK. Findings aim to inform the development of a future intervention.

Semistructured interviews were conducted with women with trauma histories (experts by experience; n=4), representatives of voluntary sector organisations (n=7) and healthcare providers (n=12). Reflexive thematic analysis was used to analyse the data. A qualitative content analysis approach was employed, supported by a Patient and Public Involvement and Engagement group (named as the ‘Research Collective’ for this study) comprising experts by experience, maternity care professionals and voluntary sector practitioners. The group contributed to both study design and data analysis.

Five descriptive categories emerged: (1) Rationale for discussions—whether and why trauma should be addressed; (2) Professionals and settings—who should lead discussions and in what environment; (3) Timing considerations—when discussions should occur; (4) Communicating about trauma—strategies to sensitively explore prior trauma; and (5) Supporting care providers—training and emotional support needs. Participants highlighted both the benefits of trauma discussions and the practical, emotional and systemic challenges involved.

Trauma discussions in maternity care are complex but essential. Findings provide practical, UK-specific insights into timing, communication and staff support considerations, highlighting the need for culturally sensitive, co-designed approaches to facilitate safe and effective trauma-informed care.

This study examined the knowledge, attitudes and practices of pregnant women regarding hypothyroidism during pregnancy.

A cross-sectional study.

Conducted at the Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan Province, China, between 10 March 2024 and 15 May 2024.

Data were obtained from 411 valid questionnaires (valid response rate: 74.46%). The average age of participants was 31.43±5.42 years.

Data were collected using a specifically designed knowledge, attitudes and practices questionnaire.

The median (IQR) scores for knowledge, attitude and practice were 14 (10, 17), 30 (23, 35) and 41 (33, 47), respectively. Awareness of thyroid hormone replacement safety during pregnancy, postpartum hypothyroidism risks and potential intellectual development issues in newborns was less than 50%.

Multivariable logistic regression indicated that knowledge score (OR=1.068, p=0.008), attitude score (OR=1.075, p

The study finds that pregnant women generally possess good knowledge, positive attitudes and proactive practices regarding hypothyroidism. It emphasises the need for healthcare providers to implement educational interventions to improve understanding and health outcomes for pregnant women with hypothyroidism.

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

A prospective cohort study.

A large tertiary care centre.

12 245 women who delivered after 22 weeks gestation in the year 2022.

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

CTRI/2022/03/041343.

Curable sexually transmitted infections (STIs) heavily rely on laboratory testing methods. Unfortunately, these diagnostic tools are infrequently used in certain regions of the country, which often results in suboptimal treatment for these infections. This study aimed to assess the prevalence of selected curable STIs among pregnant women.

Cross-sectional study.

The study was conducted in an antenatal care (ANC) unit in one of Southern Ethiopia’s general hospitals.

A total of 244 consecutive pregnant women attending the ANC follow-up were recruited for the study. All pregnant women have equal opportunity to participate; however, women who declined to be interviewed or give a sample were excluded. Pregnant women on antibiotic treatments were also excluded.

The study assessed the prevalence of selected curable STIs and associated factors. Neisseria gonorrhoea was diagnosed by culture, trichomoniasis by microscopic examination and syphilis by serological testing using a rapid diagnostic test cassette. Test results for trichomoniasis and gonorrhoea were obtained from vaginal and endocervical swabs. Factors associated with curable STIs were evaluated by bivariable and multivariate logistic regression.

The overall prevalence of curable STIs was 16.4% (40/244), with prevalence of 2% for gonorrhoea, 15.2% for trichomoniasis and 1.2% for syphilis. Alcohol intake (adjusted OR (AOR)=3.0; 95% CI 1.1 to 8.3; p=0.030), symptomatic treatment (AOR=3.6; 95% CI 1.4 to 8.6; p=0.004), residency (AOR=3.2; 95% CI 1.2 to 9.1; p=0.022) and pain while urinating (AOR=4.0; 95% CI 1.6 to 9.7; p=0.002) were all found to be associated with the existence of these STIs. This study has limitations; the cross-sectional study design and small sample size would provide limited information about factors associated with curable maternal STIs.

The study reveals a high prevalence of curable STIs among the participants, highlighting the need for further research aimed at improving their management during pregnancy.

Genitourinary syndrome of menopause (GSM) is a prevalent condition among breast cancer survivors, often exacerbated by oncological treatments. Hormonal therapies are typically contraindicated in this population, necessitating effective non-hormonal interventions.

This randomised controlled trial aims to compare the effectiveness and cost-effectiveness of multimodal pelvic floor physiotherapy—comprising pelvic floor muscle training, non-ablative radiofrequency, therapeutic pelvic health education and the use of vaginal moisturisers—versus fractional CO₂ laser therapy combined with vaginal moisturisers in alleviating GSM symptoms in breast cancer survivors. Participants will be randomly assigned to one of the two intervention groups. Primary outcomes include measures of sexual function (assessed by the Female Sexual Function Index), subjective pelvic perineal pain intensity (measured with a 100 mm Visual Analogue Scale) and health-related quality of life (assessed by the Functional Assessment of Cancer Therapy-Breast), assessed at baseline, post-intervention and at 3, 6 and 12 months of follow-up. Statistical analyses will be conducted to evaluate the clinical efficacy and cost-effectiveness of the interventions.

The study protocol has been approved by the Ethics and Health Research Committee of the University of Alcalá (Reference: CEIP/2024/1/012). All participants will provide informed consent prior to inclusion in the study. Findings will be disseminated through peer-reviewed journals and conference presentations, and by engaging with patient associations and survivor groups through tailored materials.

NCT06721936.

Minimally invasive techniques have been widely adopted for hysterectomy, including Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). However, their efficacy in patients with an enlarged uterus (≥280 g) remains not fully illustrated due to surgical complexity. We will compare the perioperative outcomes and recovery profiles of TU-LESS and vNOTES of this population in this study.

This single-blinded, two-arm, parallel-group, randomised controlled trial will take place in West China Second University Hospital. A total of 210 women with benign or precancerous uterine enlargement undergoing total hysterectomy (±salpingectomy/adnexectomy) will be randomised (1:1) to TU-LESS or vNOTES. The trial will span 2 years, including a follow-up of half a year. The primary outcomes will be the proportions achieving the indices of enhanced recovery after surgery respectively, including liquid diet tolerance, flatus passage, unassisted urination and mobility, during 24 hours after surgery and discharge within 2 days. Secondary outcomes include pain scores, operative duration, blood loss, complications, scar quality, analgesic use and pelvic/sexual function. Data collection occurs at baseline, perioperatively and 3/6 months postoperatively.

This study was approved by the Ethics Committee of West China Second University Hospital (2023 medical scientific research for ethical approval No.321). Written informed consent will be collected from all participants. Results will be shared through publication in peer-reviewed journals and presentations at conferences.

NCT06663553

Black and Asian women experience significantly higher rates of mortality and morbidity perinatally compared with white women and are more likely to lose their babies. These groups are also under-represented in clinical research, resulting in evidence that may not be generalisable. Tools have been developed to facilitate the inclusion of ethnic minority groups, but it is unknown to what extent representation and inclusion are considered in maternity trials.

To provide an overview of how ethnically diverse recruitment is considered and reported in maternity trials in the UK.

A scoping review was conducted, undertaking a systematic search to identify published trial protocols and their subsequent results papers, conducted within the UK, recruiting women during pregnancy or within 6 weeks postnatally between 2004 and 2024.

Data was extracted from protocols on whether representation of participants was considered in the study design and if specific recruitment and retention strategies were planned for ethnic minority groups.

Data extracted from results papers identified whether representation of participants was discussed and if recruitment strategies were discussed; these were compared against the protocol.

A total of 96 published protocols met the inclusion criteria; 8 mentioned specific recruitment strategies and 5 mentioned specific retention strategies. Only two included both recruitment and retention strategies. The most common strategies included providing different types of language support and adapting interventions to be culturally appropriate. Strategies were not evaluated.

67 results papers were available. Ethnicity was reported in 57 papers, with heterogeneity of categories between papers. Only 32 papers discussed representativeness of participants.

Few maternity trials report considerations on how they ensure they are recruiting and retaining ethnically representative participants. Minimal discussion is undertaken around the extent to which trial participants reflect the population to which findings will be applied.

Further work is needed to support implementation and evaluation of inclusive research guidance. Failing to ensure those from ethnic minority groups are included in research can exacerbate inequalities.

To examine the association between maternal and neonatal biochemical variables in babies born to mothers with hypertensive disorders of pregnancy (HDP) and admitted to the neonatal unit within 24 hours of delivery.

Retrospective chart review study.

Specialised antenatal hypertension clinic and neonatal unit in a tertiary unit referral hospital.

Pregnancies complicated with HDP (N=282) and their neonates if admitted to the neonatal unit within 24 hours of delivery.

We examined the association between maternal and neonatal biochemical variables, after controlling for maternal, neonatal and pregnancy characteristics.

There were strong associations and independent prediction of neonatal levels by maternal levels for urea, creatinine, sodium and calcium. The highest associations were between neonatal and maternal urea and creatinine, where the only predictor was the respective maternal variable (model R²= 0.61 and 0.60, respectively). Similarly, maternal sodium and calcium were the strongest predictors for neonatal sodium and calcium (model R²= 0.36 and 0.22, respectively). On the contrary, the strongest predictor for neonatal total protein, albumin and globulin was the gestational age (model R²= 0.43, 0.35 and 0.48, respectively) with no maternal contribution for total protein and albumin.

Maternal levels of urea, creatinine, sodium and calcium, in a pregnancy complicated by HDP, should be taken into consideration by both the obstetric and neonatal teams when deciding on timing of delivery and providing intensive monitoring.

To investigate whether treatment with oral corticosteroids and intravenous immunoglobulin (IVIg) improves pregnancy outcomes in women with unexplained recurrent pregnancy loss (RPL) following assisted reproduction technology (ART) treatment.

A randomised, double-blinded, parallel-group, placebo-controlled trial conducted from January 2021 to February 2024.

A single-centre trial at a Danish tertiary clinic for RPL management.

80 women with at least two consecutive early pregnancy losses following ART, age 18–41 years, body mass index below 35, and no identified cause of RPL. Forty participants were allocated to each group, with 37 fulfilling the protocol criteria in each group.

Participants were randomised to receive either a combination of low-dose oral prednisolone starting on the first day of menstruation and IVIg given the first time around the time of embryo transfer; or matching placebo tablets and albumin infusions. Treatment continued until gestational week 8+4 in those who conceived with a total of four infusions.

The primary outcomes were the ongoing pregnancy rate (OPR) defined as a living fetus in gestational week 13 among all randomised participants and in those who conceived after embryo transfer, respectively, based on intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included safety outcomes related to pregnancy complications and neonatal health.

OPR was equal to live birth rate. Among all randomised participants (ITT), the OPR was 25.0% in the treatment group and 15.0% in the placebo group (relative risk 1.67; 95% CI 0.67 to 4.15; p=0.26). Among participants without major protocol deviations (PP), OPRs were 21.6% and 16.2%, respectively (relative risk 1.33; 95% CI 0.51 to 3.47; p=0.55). Among participants who became pregnant following embryo transfer, ongoing pregnancy occurred in 83.3% of the treatment group and 42.9% of the placebo group (relative risk 1.94; 95% CI 1.01 to 3.75; p=0.05). No differences in adverse events or neonatal outcomes were observed between the two groups.

The combination of oral corticosteroids and IVIg did not improve overall pregnancy rates in women with RPL after ART. However, among those who achieved pregnancy after embryo transfer, the risk of pregnancy loss appeared reduced. Larger randomised trials are needed to confirm these findings.

ClinicalTrials.Gov: NCT04701034. Registration date: 5 January 2021

EudraCT number: 2020-000256-35; Registration date: 11 November 2020

The North Denmark Region Committee on Health Research Ethics: N-20200066, Registration date: 16 December 2020

The Data Protection Agency: 2020-156; Registration date: 4 November 2020

WHO universal trial number: U1111-1273-8585

Date of first patient’s enrolment: 28 January 2021.

Endometriosis, a chronic oestrogen-dependent disorder, presents significant clinical challenges including pelvic pain, dysmenorrhoea, dyspareunia and infertility. While numerous interventions exist, evidence guiding the choice among surgical, hormonal and non-hormonal therapies is fragmented. This protocol outlines a systematic review and network meta-analysis designed to comprehensively evaluate the comparative effectiveness and safety of all available treatments for endometriosis-associated pain and infertility.

We will systematically search PubMed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and WHO International Clinical Trials Registry Platform. Randomised controlled trials evaluating any intervention for endometriosis will be identified through a two-stage independent screening process by two reviewers. Primary outcomes are overall pain reduction and live birth rate. Secondary outcomes include clinical pregnancy rate, miscarriage rate, endometriosis recurrence, relief of other endometriosis-related symptoms, adverse events, quality of life and obstetrical outcomes. Data will be synthesised using pairwise and network meta-analyses.

This systematic review of published literature does not require ethical approval. Results will be disseminated through peer-reviewed publication. The findings aim to establish a robust evidence base for clinical decision-making and to inform future research priorities in endometriosis management.

CRD420251051917.

Mistreatment and obstetric violence constitute significant human rights violations with profound implications for maternal mental health. These detrimental practices persist globally, particularly in contexts where underfunded health systems, workforce shortages and entrenched gender inequalities intersect, depriving women of adequate psychosocial support and culturally sensitive mental healthcare. Although awareness of the immediate harms of mistreatment is increasing, its cumulative effects throughout the maternal care continuum remain insufficiently understood. This review will synthesise evidence on the impact of mistreatment on perinatal mental health, identify critical gaps and advocate for systemic change.

This systematic review and meta-analysis protocol complies with the guidelines set forth by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. A thorough literature search will be executed across multiple electronic databases, including CINAHL—Cumulative Index to Nursing and Allied Health Literature, Embase via Ovid, MEDLINE, PsycInfo, PubMed, Scopus, as well as other significant or specialised databases and grey literature. The review will incorporate only non-randomised study types and observational studies (cohort, cross-sectional, case-control), along with mixed-method and qualitative studies. Abstract and full-text screening will be performed by two reviewers using Covidence. The methodological quality of the included studies will be assessed using the Newcastle-Ottawa Scale for observational studies, the Risk of Bias in Non-Randomised Studies of Interventions, the Critical Appraisal Skills Programme and the Mixed Methods Appraisal Tool. Statistical heterogeneity will be evaluated using the Higgins test. Meta-analysis will be conducted using R statistical software V.4.4.4, employing random effects models to determine the weights. The study results will be reported sequentially, beginning with primary outcomes, followed by secondary outcomes and significant subgroup outcome analyses.

Ethical approval is not required as no original data will be collected. The findings of this review will be disseminated through publication and conference presentations.

CRD420251044379.

Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.

In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.

The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

NCT06151613.

Stillbirth remains a major global health challenge, with India bearing a substantial share of the burden. Despite the availability of evidence-based interventions, stillbirth rates (SBRs) remain high due to gaps in healthcare access, quality and the effective delivery of maternal and neonatal care. This study aims to develop and implement an optimised, context-specific model to reduce SBRs in Sangrur district, Punjab.

This mixed-methods implementation research will adopt a sequential explanatory design. The study will be conducted over 3 years in four blocks of Sangrur. Data will be collected through baseline and endline surveys, verbal autopsies of stillbirths, direct observations of antenatal and intrapartum care, and qualitative interviews with community members and healthcare providers. The intervention package will focus on preconception and antepartum care, intrapartum care and strengthening health systems. The study will use the plan-do-check-act model for continuous improvement, and real-time data collection through electronic systems will support timely decision-making.

The study expects to achieve a 25% reduction in SBRs through the optimised delivery of high-quality antenatal and intrapartum care services. Additionally, the research will provide critical evidence on the barriers and facilitators to optimise service delivery, as well as insights into the health system and community factors influencing stillbirth outcomes. This study aims to create a scalable and adaptable intervention model to reduce SBRs in low-resource settings like Sangrur and Punjab. The findings will inform future maternal and neonatal health policies and provide a framework for the broader implementation of similar interventions in other regions of India.

The study protocol has been approved by the International Institute of Health Management Research, Delhi (IIHMR) Institutional Ethics Committee (IRB/2024-2025/01). The study is funded through a competitive call for proposals on stillbirths by the Indian Council of Medical Research (ICMR) under the National Health Research Priority Projects (5/7BMIPR/2022-RBMCH). The research has been awarded by ICMR (project ID NHRP05586) to IIHMR under grant number 5/7/BMIPR/2022-RCN.

Drug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.

To identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programmes, can better support maternal populations in these countries.

Scoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.

Electronic search of Medline/PubMed, Embase, CINAHL and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.

Eligible resources included registries, surveillance systems and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.

Search results were screened and data extracted using a standardised form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorised by resource type.

A total of 7515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in African, Asian and Latin American LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarised according to key features, strengths and weaknesses.

This scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step towards improving safe, world-wide access to life-saving interventions for pregnant populations.

The protocol for this review has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FU5AT).

To compare birth weight-to-placental weight (BW:PW) ratios between pregnancies complicated by gestational diabetes mellitus (GDM) and normoglycaemic pregnancies, and to evaluate the associations between BW:PW ratio, perinatal outcomes, and placental histopathologic features within the GDM group.

A prospective cohort study.

A university hospital in Bangkok, Thailand.

A total of 200 women with GDM and 100 normoglycaemic controls.

BW:PW ratios were calculated and compared between the two groups. Participants with GDM were stratified into three categories based on the BW:PW ratio percentiles: 90th. Perinatal outcomes and placental histological abnormalities were analysed across these categories.

Median BW:PW ratios were not significantly different between the GDM and normoglycaemic groups: 6.3 (IQR 5.6 to 6.9) versus 6.2 (IQR 5.6 to 6.8); p=0.399. Within the GDM cohort, the BW:PW ratio cut-offs corresponding to the 10th and 90th percentiles were 5.2 and 7.6, respectively. The prevalence of small-for-gestational-age (SGA) neonates differed significantly among the three BW:PW ratio groups: 14.3% (90th); p=0.004. Similarly, the prevalence of chorangiosis varied significantly across these groups (66.7%, 52.9% and 22.7%, respectively; p=0.009). A BW:PW ratio 90th percentile was associated with reduced odds of chorangiosis (aOR 0.35; 95% CI 0.11 to 0.85).

BW:PW ratios did not differ significantly between the GDM and normoglycaemic groups. However, in GDM pregnancies, extremes in the BW:PW ratio were associated with distinct perinatal and placental outcomes, indicating altered placental efficiency and potential clinical relevance.

TCTR20211122001.

This study aimed to investigate the trajectory patterns and influencing factors of sleep quality and verify the bidirectional association between physical activity and sleep quality during pregnancy.

This was a prospective longitudinal study.

The study was conducted at the obstetric clinic in a tertiary maternity hospital in Zhejiang Province, mainland China.

A total of 645 pregnant women were selected through simple random sampling and completed follow-up assessments during the first, second and third trimesters of pregnancy from January to December 2024.

The desired data were collected using the Pittsburgh Sleep Quality Index and the International Physical Activity Questionnaire Short Form. Latent class growth analysis was applied to identify sleep quality trajectories, multiple logistic regression was used to determine the influencing factors, and cross-lagged panel analysis was used to explore the bidirectional association between sleep quality and physical activity.

Three distinct sleep quality trajectories were identified: the constantly poor sleep quality group (21.40%), the constantly decreasing sleep quality group (50.70%) and the constantly good sleep quality group (27.90%). Multiple logistic regression analyses indicated that being underweight (OR=3.013, 95% CI: 1.308 to 6.942) and having insufficient physical activity levels during the first (OR=3.346, 95% CI: 2.009 to 5.573) and second phases (OR=37.515, 95% CI: 20.215 to 69.620) were associated with an increased risk of exhibiting a consistently declining pattern. Being underweight (OR=2.679, 95% CI: 1.041 to 6.893), passive smoking (OR=11.433, 95% CI: 2.220 to 58.883) and having insufficient physical activity levels during the first (OR=12.624, 95% CI: 6.285 to 25.356) and second phases (OR=23.773, 95% CI: 11.745 to 48.118) were associated with an increased risk of exhibiting a consistently poor pattern. Additionally, results from the cross-lagged panel analysis revealed a bidirectional association between sleep quality and physical activity.

This study demonstrates heterogeneity in changes in sleep quality among pregnant women. Interventions aimed at promoting maternal and infant health during pregnancy should consider both sleep quality and physical activity. Earlier interventions are associated with better outcomes.

ChiCTR2300078952.

To examine trends in preconception and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, obstetric interventions, and the impact of COVID-19, and to forecast future disease burden.

A multi-centre retrospective cohort study.

A large hospital network with three maternity hospitals serving ethnically diverse populations in Melbourne, Australia.

Pregnant women who gave birth between 2016 and 2022.

Trends in cardiometabolic conditions, birth complications and obstetric interventions.

Over 7 years, 63 232 women were included, of whom 40% were nulliparous, and 60.9% were born overseas from 167 countries. From 2016–2022, maternal age (30.2–31.3 years), obesity (21.0%–26.2%), gestational diabetes mellitus (GDM) (15.9%–28.1%) and caesarean delivery (28.5%–37.6%) increased, while average gestational weight gain, premature births and special care admissions declined from 12.6–11.6 kg, 6.3%–4.9% and 24.2%–14.1%, respectively; and was statistically significant (p

Prepregnancy and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, and obstetric interventions increased markedly over 7 years. Despite this, offspring complications, including special care admissions, stillbirths and prematurity, decreased, while pregnancy complications peaked during COVID-19. GDM is forecasted to increase to 43.0% by 2028, posing an unsustainable health and economic burden that necessitates urgent public health initiatives.

To assess the knowledge, attitudes and practices (KAP) of male relatives of pregnant women regarding labour pain and analgesia.

A cross-sectional study.

Conducted at a maternal hospital in eastern China from 28 December 2023, to 3 April 2024.

Male relatives who accompanied pregnant women during antenatal registration visits.

Primary outcome: KAP levels. Secondary outcomes: demographic and social factors associated with KAP.

Among 547 invited participants, 533 responded (response rate: 97.4%). Of these, 94.1% were spouses. Median KAP scores were 5.00, 30.00 and 21.00. Most participants lacked knowledge about labour analgesia and had safety concerns. Structural equation modelling showed knowledge had a direct effect on attitude (β=0.577, 95% CI 0.483 to 0.671) and an indirect effect on practice via attitude (β=0.602, 95% CI 0.463 to 0.740). Multivariate analysis identified associations between knowledge and education (OR=3.705, 95% CI 2.136 to 6.425), religious belief (OR=0.268, 95% CI 0.095 to 0.756) and delivery cost awareness (OR=0.175, 95% CI 0.045 to 0.675). Knowledge (OR=1.076, 95% CI 1.016 to 1.139) and attitude (OR=1.457, 95% CI 1.337 to 1.588) predicted practice.

Male relatives showed limited knowledge, overall negative attitudes, but also showed compassion and concern, and insufficient practice and inadequate practices regarding labour pain and analgesia. Educational strategies targeting male relatives are needed to improve perinatal support.