To explore maternity care providers’ attitudes toward regional centralisation of vaginal breech birth (VBB) care and gather their recommendations for maintaining clinical proficiency.

Exploratory qualitative study using semi-structured interviews and thematic analysis.

10 hospital-based maternity care professionals (nine obstetricians and one clinical midwife), purposively sampled to represent experience and institutional diversity.

10 hospital maternity units in a metropolitan region of the Netherlands.

Key themes describing provider attitudes towards two proposed models of centralised care (mobile breech team, designated referral centre) and alternative strategies.

Three core themes emerged: (1) proficiency—providers valued regular exposure, formal training and peer support, expressing concern that centralisation would reduce overall workforce readiness; (2) organisation—concerns included unequal access, staffing burden, legal risks and inefficiencies in mobile teams and (3) alternatives—participants preferred a regional breech network with shared training, joint video review and expert on-call support.

Maternity care providers opposed full centralisation of VBB, favouring a networked model that distributes expertise and preserves local access. These insights highlight the importance of involving frontline providers in service redesign.

Not applicable.

Women experiencing infertility employed various coping strategies to overcome the diverse stressors encountered. These coping strategies had their peculiar consequences or outcomes. This study aimed to explore the outcomes deduced from the coping strategies employed by women with infertility.

The study employed a qualitative descriptive research design to gain an in-depth understanding of the outcomes of coping strategies used by women with infertility. In-depth interviews were conducted using a semi-structured interview guide.

The study was carried out at a private fertility and specialist hospital within the Kumasi Metropolitan Assembly, where 15 women diagnosed with primary infertility were interviewed for 45 min to 1 hour each. With all participants completing the study, interviews were audiotaped with consent, transcribed verbatim and analysed using content analysis.

The findings revealed that women with infertility used various coping strategies to mitigate the psychosocial stressors encountered. The coping strategies employed had a varying impact on the well-being of women with infertility, from long-term (physical health, mental health and life satisfaction) to short-term (composure and reduced state anxiety) coping outcomes. The result of the coping strategy employed had a varying impact on the well-being of women with infertility.

Women with infertility shared how they experienced good physical health, mental health and life satisfaction after employing adaptive coping strategies like seeking social support. They also shared how they exercised composure and had reduced state anxiety after using some maladaptive coping strategies, such as self-control and avoidance.

Although breastfeeding is associated with lower postnatal depression and anxiety, limited research exists regarding long-term maternal mental health outcomes. This study examined the association between breastfeeding and depression and anxiety in women of later reproductive age (mid 30s to menopause).

This was a 10-year prospective longitudinal cohort study. Self-reported questionnaires were used to collect lifetime breastfeeding behaviour at 10 years, and health history including depression, anxiety and medication use was collected at each study timepoint.

A tertiary level maternity hospital in Dublin, Ireland.

168 parous women from the ROLO Longitudinal Cohort with lifetime breastfeeding behaviour and health history data available at 10 years were included (22% of total cohort). Women currently pregnant or breastfeeding at 10-year follow-up were excluded.

Mean (SD) age at study end was 42.4 (3.8) years. 72.6% (n=122) of women reported ever breastfeeding. Median lifetime exclusive breastfeeding was 5.5 weeks (IQR 35.8, range 0–190). 37.5% of women (n=63) breastfed for ≥12 months over their lifetime. 13.1% (n=22) reported depression or anxiety at 10 years, and 20.8% (n=35) reported depression or anxiety over the whole study period. Ever breastfeeding was associated with less depression and anxiety at 10 years (OR 0.34, 95% CI 0.12 to 0.94, p=0.04). Ever breastfeeding, longer exclusive breastfeeding and lifetime breastfeeding ≥12 months were associated with lower depression and anxiety over the whole study period (ever breastfeeding OR 0.4, p=0.03; exclusive breastfeeding OR 0.98/week, p=0.03; lifetime breastfeeding ≥12 months OR 0.38, p=0.04).

There may be a protective association between breastfeeding and self-reported depression and anxiety. Further studies are required to confirm the findings.

ISRCTN54392969.

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.

To assess whether gynaecological follow-ups among adolescent and young adult (AYA) cancer survivors are less compliant with recommendations than those without a history of AYA cancer.

A retrospective national cohort study with exposed–unexposed design was conducted using the French National Health Data System.

The exposed group included AYAs who underwent cancer treatment in France between 2012 and 2014 and was matched in a 1:1 ratio with the unexposed group of AYAs without cancer or chronic disease.

A total of 7312 AYAs initiated cancer treatment during the specified period. After applying exclusion criteria, 3663 AYAs were matched to unexposed AYAs.

The primary outcome was compliance with gynaecological follow-up recommendations, including gynaecological consultation, sexually transmitted infections screening and cervical cancer screening. Secondary outcomes involved assessing each component of the follow-up, along with human papillomavirus vaccination coverage.

Exposed AYAs were significantly more likely to comply with gynaecological follow-up guidelines, with a compliance rate of 23.2%, compared with 16.5% among unexposed AYAs (OR 1.53, 95% CI 1.36 to 1.70; p

AYA cancer survivors were more likely to have gynaecological follow-up compliant with recommendations, including gynaecological consultations, sexually transmitted infections and cervical cancer screenings.

Folic acid is crucial for fetal development, particularly during early pregnancy. Studies suggest that high folic acid intake (≥800 µg/day) may be associated with a reduced risk of miscarriage. However, the impact of an 800 µg dose on pregnancy outcomes in women with prior pregnancy loss currently remains unclear.

We will conduct a multi-centre randomised controlled study comparing 800 µg and 400 µg in women with previous pregnancy loss. The primary outcome is live birth. Secondary outcomes include early pregnancy loss, ongoing pregnancy at 24 gestation weeks, homocysteine (Hcy) reduction, maternal and perinatal outcomes. We plan to recruit 1116 women (558 women per group). Data analysis will follow the intention-to-treat principle and per-protocol. Subgroup analysis will be conducted based on Hcy levels, previous pregnancy losses and body mass index.

ChiCTR2500100255.

To determine the prevalence and risk factors for full stomachs as assessed by gastric ultrasound in patients scheduled for elective caesarean section (CS).

Case-control study.

One tertiary general hospital in Beijing.

A total of 140 non-labouring singleton pregnant women scheduled for elective CS between March 2024 and November 2024 at Peking University International Hospital were enrolled in this study. The inclusion criteria were as follows: ≥18 years of age, ≥37 weeks of gestational age, an American Society of Anesthesiologists physical status of II to III, and the ability to understand the rationale of the study assessments. The exclusion criteria included multiple pregnancy, obstetric urgency, an antenatal history of upper gastrointestinal surgery or upper gastrointestinal tract disease, the use of medications that may influence gastrointestinal motility and refusal to participate in the study.

Based on quantitative and qualitative ultrasound assessments of the gastric antrum, patients were divided into two groups: a full stomach group (defined by a Perlas A score of grade 2 or the presence of solid contents or a gastric volume (GV)/weight >1.5 mL/kg) and an empty stomach group (defined by a Perlas A score

The prevalence and risk factors for full stomachs in patients scheduled for elective CS.

A total of 134 parturients were analysed. Overall, 48 parturients (35.8%) were identified as having a full stomach despite adherence to standard fasting rules for elective CS. According to multifactorial logistic regression analysis, gastro-esophageal reflux disease (GERD) during pregnancy (adjusted OR: 3.90; 95% CI 1.15 to 13.23; p=0.029) was identified as an independent risk factor for full stomachs in patients scheduled for elective CS.

In this study, we found that GERD during pregnancy is an independent risk factor for full stomachs as assessed by gastric ultrasound in patients scheduled for elective CS. Our results suggest that if a parturient has GERD during pregnancy, it would be desirable to perform gastric ultrasound to evaluate gastric emptying status prior to anaesthesia.

Chinese Clinical Trials Registry at http://www.chictr.org.cn (ChiCTR2400082033).

Endometriosis is a common, benign, chronic inflammatory disease with multiple consequences, from chronic pain to systemic comorbidities and poor quality of life. As it usually affects people of reproductive age, one of the most distressing consequences is infertility, which can be only partly overcome by medically assisted reproduction. Poor outcomes are, in fact, frequent adverse events. As no definitive therapy exists for endometriosis-related infertility, affected women often tend to try either complementary and alternative medicine or self-management strategies to improve their quality of life, with the hope of also enhancing their fertility. Among available options, dietary interventions are commonly explored, even if no robust evidence is available on the optimal type of diet and its effects on reproductive outcomes. This trial will investigate whether an anti-inflammatory dietary intervention can improve fertility outcomes in women affected by endometriosis undergoing in vitro fertilisation (IVF).

The DietAry interveNtion in ameliorating fertiliTy parameters in women with Endometriosis undergoing IVF (DANTE) study is a single-centre, randomised, controlled, non-pharmacological interventional trial in patients living with endometriosis who are infertile and require IVF. Participants will be allocated to either a 12-week intervention based on an anti-inflammatory diet or no diet before the beginning of controlled ovarian stimulation. Following baseline assessment, 438 participants aged

The study has received ethics approval from Comitato Etico Territoriale Lombardia 3 (#5587_18.12.2024). Results will be presented in peer-reviewed journals and at international conferences.

NCT06885125.

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.

Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.

DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.

This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (

The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.

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.