Elinzanetant, a novel, dual neurokinin-targeted therapy, has been approved in various geographies for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. To compare the efficacy of elinzanetant with non-hormonal pharmaceutical treatments (nHT) in alleviating VMS. A systematic literature review of Medline, Embase, and Cochrane databases identified randomised controlled trials (RCTs) published up to October 2025. RCTs of nHT in women with moderate-to-severe VMS not induced by medical treatment, reporting week 12 results for VMS frequency and severity, sleep disturbances, and quality of life. Treatments were compared using a Bayesian network meta-analysis to obtain mean differences (MD) or odds ratios (OR) with 95% credible intervals. Of 17 included RCTs, three assessed elinzanetant 120 mg, two paroxetine 7.5 mg (PRX), four gabapentin 1200-1800 mg (GABA), three fezolinetant 45 mg (FEZO), and five desvenlafaxine 50-200 mg (DVS). Elinzanetant significantly reduced daily VMS frequency versus PRX (MD: -2.11 [-3.31, -0.92]), DVS (MD: -2.77 to -1.72), and GABA (MD: -2.22 to -2.31). The proportion of patients with ≥ 50% reduction in VMS frequency was significantly greater with elinzanetant than DVS 100 mg (OR:1.52 [1.03, 2.24]) and PRX (OR:2.20 [1.49, 3.28]), and comparable to DVS 150 mg and FEZO. Elinzanetant significantly reduced VMS severity versus DVS 50 mg (MD: -0.37 [-0.56, -0.17]) and was comparable with other assessed treatments. Elinzanetant reduced nighttime awakenings significantly more effectively than PRX (MD: -0.82 [-1.26, -0.39]) and all DVS regimens. Elinzanetant significantly improved sleep disturbance (PROMIS SD-SF-8b) score versus FEZO (MD: -2.67 [-3.92, -1.42]). Change in MENQoL did not differ significantly. In this indirect comparison, elinzanetant showed superior or comparable efficacy to NKT or nHT in reducing the frequency and severity of VMS, along with improving sleep disturbances, supporting its role in VMS management. Many women experience disruptive symptoms during menopause. Some of the most frequent symptoms include vasomotor symptoms and sleep disturbances, and both can impact women's quality of life. Hormone therapies have been used to treat these symptoms, but they can have side effects, and some women are either not able to or do not wish to be treated with hormone therapies. Non‐hormonal therapies, such as the recent neurokinin‐targeted therapies, are options for women who cannot or do not want to use hormone therapies. The objective of this study was to indirectly compare the efficacy of a new neurokinin‐targeted therapy, called elinzanetant, with non‐hormonal therapies in reducing menopausal symptoms such as hot flashes and improving sleep disturbances. This analysis includes data from 17 clinical trials that evaluated various non‐hormonal treatments for menopausal symptoms. Each trial compared a treatment to placebo. To assess and compare the effectiveness of these treatments, researchers used a method called network meta‐analysis. This statistical technique allows for indirect comparisons between treatments, even when they haven't been directly tested against each other in the same clinical trial. While network meta‐analysis does not replace direct head‐to‐head clinical trials, it can provide useful insights for decision‐makers, such as healthcare payers. In this analysis, results were considered statistically significant if the 95% credible interval did not include the null value. The non‐hormonal therapies examined in this study have all demonstrated some effectiveness in managing menopause symptoms such as hot flashes. These therapies include desvenlafaxine (a serotonin‐norepinephrine reuptake inhibitor) and paroxetine (a selective serotonin reuptake inhibitor), which are antidepressants; gabapentin, an anticonvulsant; and fezolinetant, a recently approved neurokinin‐targeted therapy. Among these, only fezolinetant and paroxetine have been specifically approved for the treatment of vasomotor symptoms associated with menopause. Notably, paroxetine has received this approval only in the United States. Elinzanetant was found to be more effective than desvenlafaxine, gabapentin, and paroxetine in reducing the frequency of hot flashes. It also improved sleep disturbances better than other treatments, including fezolinetant. Elinzanetant was found to be comparable with gabapentin and fezolinetant in improving quality of life. These results should be interpreted in the context of estimates being derived from an indirect comparison. Elinzanetant appears to be a promising additional treatment option for reducing menopausal symptoms, namely hot flashes and sleep disturbances, based on results of this indirect comparison.
Pelvic examinations are a routine element of gynaecological and obstetric care but may generate discomfort, pain and anxiety. Objectives To evaluate the effectiveness of interventions to improve women's experience of pelvic examinations. Search Strategy Medline, Cochrane Library, Embase, Web of Science and ScienceDirect were searched to identify randomised interventional trials published between January 1990 and December 2024. Selection Criteria Eligible studies compared an intervention group and control group of > 15-year-old women undergoing pelvic examinations and reported physical and emotional responses, such as pain, anxiety, discomfort and embarrassment. Data Collection and Analysis Two reviewers independently screened, extracted data, and assessed the risk of bias using the Cochrane Risk-of-Bias 2 (RoB2) tool. Data were analysed using pooled standardised mean differences (SMD) with 95% confidence intervals (CI) and random effects models. Heterogeneity was assessed with the I2 statistic. Sixteen RCTs (4641 women) were analysed. Fourteen studies assessed interventions targeting women's perceptions: procedural strategies (n = 10), environmental adaptations (n = 2), and cognitive approaches (n = 2). Two studies evaluated the information provided to the patient about the examination and an online preparatory training (n = 2). The meta-analysis showed a significant reduction in pain (SMD -0.87, 95% CI -1.56 to -0.18; p = 0.001; 8 studies) and in anxiety (SMD -1.13, 95% CI -1.86 to -0.38; p = 0.003; 5 studies). Risk of bias was high (n = 5), some concerns (n = 4), and low (n = 7). Heterogeneity was high (pain: I2 = 96.3%; anxiety: I2 = 94.8%). Simple interventions may reduce pain and anxiety during pelvic examinations and support trauma-informed care, but the heterogeneous evidence requires more high-quality research.
To explore the experiences of women and clinicians during the introduction of uterine transplantation (UTx) to the UK. A qualitative study utilising prospective case study methodology (interviews and observations) over 6 years. In the UK, five uterine transplants have been completed to date-two using living donors and three using deceased donors. In addition, three deceased donor retrievals were undertaken but did not proceed to implantation. Data included 18 audio-recorded consultations with potential recipients and clinicians, 22 interviews with seven clinicians and eight follow-up interviews with women. Data were synthesised using thematic analytical methods. The first theme, 'Emotional and ethical dimensions of UTx decision-making', explores how women and clinicians navigated uncertainty, risk and hope, including dilemmas around living versus deceased donation. The second, 'Building and refining a UK UTx programme', reflects on bridging disciplines, managing initial cases and iteratively improving protocols through teamwork and reflection. The third, 'Living through the unknowns after transplantation', captures recipients' post-operative experiences, their collaboration with clinicians, and uncertainties surrounding recovery, embryo transfer and pregnancy. Prospective qualitative research enabled surgeons to reflect on their practice while generating insights to optimise uterine transplant delivery in the UK and internationally. Findings offer practical guidance for navigating uncertainty and risk when introducing new procedures and highlight ways to strengthen support for women throughout the process. Overall, this study demonstrates how prospective qualitative methods can provide crucial insights into the technical, ethical and emotional dimensions of innovative procedures like UTx.
The transition through menopause is accompanied by a series of adverse metabolic changes which are associated with an increased risk of cardiometabolic disease, a major cause of mortality in women after midlife. Whilst the indication for menopausal hormone replacement therapy (HRT) is the control of menopausal symptoms, understanding and discussing the cardiometabolic impacts of HRT are necessary to facilitate informed decision-making at treatment initiation and continuation, and to select appropriate regimens. A narrative review. Existing evidence suggests that HRT is likely to impact the development of metabolic risk factors including visceral fat accumulation, adverse changes in lipid profile, blood pressure and glycaemic control. Findings from randomised controlled trials have refined our understanding of the impact of HRT on cardiometabolic outcomes including coronary heart disease and stroke. Furthermore, recent research has highlighted the impact of the menopause on the development and severity of metabolic dysfunction-associated steatotic liver disease (MASLD) that has been poorly studied in the context of HRT. The route of oestrogen administration, timing of initiation and type of progestogen are all likely to affect the impact of HRT on many of these outcomes. There has recently been extensive media interest in HRT in some countries resulting in increased prescription rates. Understanding the impact of HRT on cardiometabolic risk is therefore particularly important. In this narrative review, we discuss the existing evidence and clinical guidelines on the effect of HRT on cardiometabolic risk factors and the risk of coronary heart disease, stroke and MASLD, highlighting areas of uncertainty and priorities for further research.
To assess the measurement properties of the International Consultation on Incontinence-Perinatal Pelvic Health Self-Assessment Questionnaire (ICIQ-PPHSAQ) and to identify symptom subscales for scoring. Two cohorts of perinatal women (antenatal and postnatal) at nine NHS trusts in England completed ICIQ-PPHSAQ at baseline (16-19 weeks' gestation for the antenatal cohort and 6-9 weeks postnatal for the postnatal cohort) and at up to three further timepoints, with follow-up extending to 9 months postnatal. Descriptive analyses and exploratory factor analyses (EFAs) identified symptom subscales from which subscale scores were calculated. Internal consistency was evaluated using Cronbach's alpha (α). Test-retest reliability was assessed using an interval of 1 week after baseline, using weighted Kappa (κ) for individual ordinal items and the intraclass correlation coefficient (ICC) for subscale scores. Construct validity and known-groups validity were assessed by comparison with the Patient Global Impression of Severity (PGI-S). Responsiveness was assessed by examining the mean differences between baseline and each timepoint. A total of 162 antenatal women who were 16-19 weeks gestation, and 173 women 6-9 weeks postnatal were recruited. Almost all the items performed acceptably in the test-retest analyses and completion rates were high in all the scored items (< 5% missing data). EFAs derived nine symptom subscales; seven of which had acceptable overall reliability indicators, except the vaginal symptom and vaginal changes subscales. Known-groups validity was demonstrated for all nine subscales, and six out of nine showed responsiveness to change (p < 0.05) over the study time-period. The study provides evidence supporting the validity and reliability of ICIQ-PPHSAQ, with responsiveness demonstrated across several domains. The instrument can be used to assess perinatal pelvic floor dysfunction risk factors and symptoms in English perinatal pelvic health services.
To determine associations between gestational diabetes mellitus (GDM) and body mass index (BMI) change between consecutive pregnancies, and hospital length of stay (LOS) and hospital costs. Retrospective cohort study. Two maternity hospitals, New South Wales, Australia. Women with two most recent singleton births between September 2011 and April 2019. Multivariable generalised linear models assessed association between GDM status (none, first only, second only, or both pregnancies) and BMI change (loss: < -1 kg/m2; stable: -1 to < 1; small gain: 1 to < 2; medium gain: 2 to < 4; or large gain: ≥ 4) in relation to second-birth LOS and hospital birthing costs. Costs were calculated using DRG codes and valued in 2024 AUD. Hospital LOS and hospital costs for the second birth. Of 11 157 women, 5% had GDM only in the first pregnancy, 9% only in the second and 8% in both. For the second birth, women with GDM in both pregnancies stayed 0.91 days longer (3.71 vs. 2.79 days) and incurred AU$1960 higher costs (AU$14680 vs. AU$12720) than those without GDM in either pregnancy. Adjusted models indicated GDM in both pregnancies was associated with a 21% longer LOS (95% CI: 16%-26%, p < 0.001) and 9% higher costs (7%-11%, p < 0.001). Large BMI gain (≥ 4 kg/m2) was associated with a 9% longer LOS (4%-14%, p < 0.001). Women with both GDM (both pregnancies) and large BMI gain had a 23% longer LOS (12%-36%, p < 0.001) and 9% higher costs (4%-15%, p < 0.001). GDM and interpregnancy BMI gain were associated with increased hospital stay and higher birthing-related hospital costs for the second birth. These findings underscore the importance of preventive strategies and supportive public health policies to reduce the burden of GDM and high BMI gain. Approaches such as nutritional counselling, lifestyle modification and physical activity programs are likely to support women planning a subsequent pregnancy after their index birth (first pregnancy or first pregnancy with GDM diagnosis).
To estimate the incidence of eclampsia, characterise maternal and perinatal profiles, and document outcomes across seven countries within the International Obstetric Survey System and identify inter-country differences that may improve maternal and perinatal care. Multi-country analysis of population-based cohort data. Six high-income countries (Belgium, France, Italy, the Netherlands, Norway, Slovakia) and one upper-middle-income country (Suriname). All women admitted with eclampsia in participating countries between 2012 and 2019. Individual participant data meta-analysis. Incidence of eclampsia, maternal demographics, pregnancy characteristics, clinical management, mode of delivery and maternal and perinatal outcomes. 615 cases of eclampsia were notified resulting in a pooled incidence of eclampsia of 2.2 per 10,000 deliveries in high-income countries and 36.6 per 10,000 deliveries in Suriname. About 42% of women were diagnosed with preeclampsia before seizure onset and one-third experienced their first seizure postpartum. Hypertension was the most reported clinical sign (91.1%). Most women were treated with magnesium sulphate (91.1%) and antihypertensive medications (89.8%). Caesarean section was performed in 72.7% of cases. About 53% of births was preterm with most of them linked to antepartum cases. Maternal and neonatal deaths were rare but more frequent in Suriname. The declining incidence of eclampsia in Europe may be attributed to enhanced management, supported by ongoing audits and confidential enquiries; however, potential ascertainment bias limits causal interpretation. Global efforts remain crucial to promote awareness, timely prevention and implement standardised management guidelines for eclampsia across all settings.
To investigate risks of pregnancy and birth in patients with peripheral vascular malformations (VMs). Nationwide cross-sectional study. Tertiary referral centre and Dutch national patient organisation. Women aged ≥ 15 years diagnosed with peripheral VM of any subtype or anatomical location. Patients were invited to complete a comprehensive questionnaire about obstetric history and VM-related symptoms during pregnancy. Prevalence of complications, specifically worsening of VM-related symptoms during pregnancy, deep venous thrombosis (DVT), pulmonary embolism (PE) and postpartum haemorrhage (PPH). Two-hundred-six women completed the questionnaire. Among 108 patients, 248 pregnancies and 204 births were reported; 98 patients were nulligravid. DVT and PE occurred in 2.5% and 0.5% of total pregnancies, respectively and only occurred in patients with extensive VMs (> 30 cm) involving at least the lower extremities (predominantly Klippel-Trenaunay). PPH occurred in 19.6% of births, including in 63.6% of those with uterine involvement and 47.8% with genital involvement of the VM. VM-related symptom worsening and volume increase during pregnancy occurred in 47.6% and 45.4% of patients, respectively. In multivariable regression, AVM subtype (OR 4.0, 95% CI 1.0-15.1), genital region involvement (OR 4.6, 95% CI 1.5-13.8), and a history of puberty-related symptom progression (OR 2.6, 95% CI 1.1-6.2) were independently associated with VM-related symptom worsening during pregnancy. Women with VMs appear to have a significant risk of PPH and worsening of VM-related symptoms during pregnancy, especially if the genital region is involved. Increased thromboembolic risk appears confined to patients with extensive VMs involving the lower extremities.
To determine the diagnostic yield of a nationally implemented first-trimester anomaly scan (FTAS), compared to standard obstetric care with a second-trimester anomaly scan. Prospective observational cohort study. Nationwide prenatal screening program in the Netherlands. Pregnant women referred for suspected fetal anomalies with subsequent abnormal diagnostic scans in 2021-2022. All fetal diagnoses < 18 weeks' gestational age (GA) were registered: 8 months before (BEFORE) and 1 year after (AFTER) FTAS implementation. BEFORE-cohort: referrals after routine scans (e.g., dating scans). AFTER-cohort: all referrals, including FTAS. Corrections were made for missing referrals < 12 + 3 weeks in the AFTER-cohort. Time adjustment was made in the BEFORE-cohort. Anomalies were categorised as: First-Trimester Major Anomalies (FTMA), often detectable anomalies and other anomalies. Number of fetal anomalies, time to final diagnosis, GA at termination of pregnancy (TOP). Abnormal diagnostic scans increased from 750 to 1261 (BEFORE vs. AFTER) with definitive diagnoses in 609 vs. 940. Time to diagnosis and GA at TOP in c-BEFORE were comparable to c-AFTER (11 vs. 13 days and GA 14 + 6 vs. 15 + 1, respectively). FTAS increased the detection of often detectable and other anomalies (53 vs. 124 and 248 vs. 474, respectively). FTMA slightly increased (308 vs. 342). FTAS substantially increases detection of fetal anomalies, primarily often detectable and other anomalies. Overall GA at diagnosis or TOP increased marginally, but some cases required an extended period of diagnostic evaluation.
Pre-eclampsia is a leading cause of maternal and perinatal morbidity and mortality, with risk factors reported across a vast literature base fragmented between social and clinical factors. To develop a comprehensive conceptual framework of the strongest risk factors and their relationships contributing to pre-eclampsia incidence. Medline, Embase, Health Technology Assessments and Database of Abstracts of Reviews of Effects, Cochrane Library were searched. Reviews, randomized controlled trials and cohort studies (> 1000 participants), reporting social and clinical factors associated with pre-eclampsia were included. The strongest factors, defined as those with at least moderate strength of association and quality of evidence using GRADE, were compiled from our previously published individual frameworks to create a combined conceptual framework. Indirect associations were searched and the strongest indirect factors were added. The conceptual framework integrated 35 social and clinical determinants of pre-eclampsia. Key modifiable factors included BMI, interlinked with chronic hypertension/elevated blood pressure in early pregnancy, type 2 diabetes mellitus, and obstructive sleep apnoea, as well as antenatal care attendance, interconnected with maternal/work stress and prenatal micronutrient supplementation. Other modifiable factors included smoking, antiphospholipid syndrome, infection, exposure to occupational hazards, distance to health facility, maternal heat exposure in early gestation, and UV-B exposure. There are strong social factors alongside clinical factors associated with pre-eclampsia incidence. Interwoven relationships between factors highlight the multifactorial aetiology of pre-eclampsia. Many determinants were potentially modifiable, which provides actionable intervention points for clinical care and public health strategies.
Royal College of Obstetricians and Gynaecologists (RCOG) Green-top Guidelines (GTGs) provide evidence-based recommendations in women's health. Even where evidence is considered high quality, it is uncertain whether factors known to influence maternity outcomes are reflected in study design. To determine distribution of recommendation grades across obstetric GTGs. For Grade A recommendations, to evaluate if supporting studies reported equity-relevant design features and methodological robustness. Review of RCOG obstetric GTGs. United Kingdom. All RCOG non-archived obstetrics GTGs published up to 20 April 2025. Frequencies of Grade A-D recommendations and Good Practice Points were recorded. For Grade A recommendations, underpinning studies were assessed for health equity and generalisability. All primary studies underpinning every Grade A recommendation were included; where a single study supported multiple recommendations, it was included every time and mapped to each relevant recommendation. The median health equity and generalisability score for each recommendation (if > 1 supporting studies) and a median score of all Grade A recommendations per guideline was calculated. Distribution of recommendation grades: health equity and methodological robustness scores for studies underpinning Grade A recommendations. Variable frequencies of Grade A, B, C, D recommendations and GPP from 37 eligible guidelines were noted. Only 28 GTGs had Grade A recommendations, with median health equity and generalisability scores of 1 of 13 and 6 of 10 respectively across those recommendations. Twenty-four percent of obstetric GTGs have no Grade A recommendations. Of those that do, consideration of health equity and generalisability in associated studies is limited. These design and reporting features should be considered in future research to improve applicability of clinical guidance to all patient groups.
To compare the efficacy, safety and perioperative outcomes of robotic-assisted sacrocolpopexy (RASC) versus laparoscopic sacrocolpopexy (LSC) for the surgical management of apical or multicompartment pelvic organ prolapse (POP). Systematic review and meta-analysis of randomised controlled trials (RCTs) and observational studies (PROSPERO CRD42025111099), conducted according to PRISMA guidelines. Secondary and tertiary care centres. Women undergoing sacrocolpopexy for POP. Medical databases (PubMed, Scopus, ISI Web of Science, Embase, Cochrane) were searched from inception to April 2025 for studies comparing RASC versus LSC. Risk-of-bias was assessed using the Cochrane tool for RCTs and Joanna Briggs Institute checklists for observational studies. Data were meta-analysed separately by study design using odds ratios (ORs) and standardised mean differences with 95% confidence intervals (CIs), applying fixed- or random-effects models according to heterogeneity. Operative time, anatomical outcomes, complications, conversion to laparotomy, recurrence and patient-reported outcomes. Five RCTs and twenty-four observational studies were included. In RCTs, no significant differences between RASC and LSC in operative time, anatomical outcomes or patient-reported outcomes were found, with similar intraoperative and post-operative complication rates. In observational studies, perioperative outcomes, complications, mesh exposure, readmissions and recurrence were comparable, but RASC ensured lower conversion to laparotomy (OR 0.2, 95% CI 0.1-0.3). RASC and LSC provide equivalent anatomical and clinical outcomes with similar morbidity. RASC may be particularly useful in complex or technically demanding cases.
To develop antenatal prediction models for shoulder dystocia and birth trauma using routinely collected maternal and sonographic variables. Retrospective cohort study. Single tertiary referral centre in the UK. All singleton term liveborn pregnancies delivered between January 2016 and November 2024 with a third-trimester ultrasound performed at or beyond 36 weeks' gestation. Multivariable logistic regression was used to develop antenatal prediction models for shoulder dystocia and birth trauma, incorporating maternal characteristics and fetal biometry including abdominal circumference (AC; centile or mm) and estimated fetal weight (EFW; grams or centile). Model performance was assessed using tests for multicollinearity, discrimination (area under the ROC curve, AUC) and calibration. Shoulder dystocia and birth trauma, the latter defined as a composite of shoulder dystocia, postpartum haemorrhage requiring blood transfusion, caesarean delivery at full dilatation, or hypoxic-ischaemic encephalopathy (HIE ≥ 1). A total of 24 334 singleton term pregnancies were included; 432 (1.8%) were complicated by shoulder dystocia and 1210 (5.0%) by birth trauma. The model including maternal characteristics and AC centile demonstrated the best discrimination. For shoulder dystocia, the apparent AUC was 0.706 (95% CI 0.682-0.730); the optimism-corrected AUC after bootstrap validation was 0.699. For birth trauma, the apparent AUC was 0.669 (95% CI 0.654-0.685); the optimism-corrected AUC was 0.665. At a 10% false-positive rate, sensitivity was 31.5% for shoulder dystocia and 22.8% for birth trauma, compared with 20.4% and 14.0%, respectively, using EFW ≥ 90th centile. Antenatal models combining fetal AC centile with maternal risk factors outperform EFW-based thresholds currently used in clinical practice. Although discrimination was modest, the model may be useful for antenatal risk stratification and counselling, rather than as a stand-alone clinical test. Such models may help identify pregnancies at increased risk of delivery-related complications associated with fetal overgrowth and inform future studies evaluating targeted interventions.
To investigate whether angiogenic biomarkers at term in low-risk pregnancies are associated with the timing of spontaneous and induced labour, and to assess changes from term to post-term gestation. Prospective, non-interventional, observational cohort study. Single tertiary care centre, Switzerland. Low-risk term and post-term pregnancies. Soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) were measured and time intervals from sampling to delivery were analysed in spontaneous (n = 136) and induced labour (n = 48). Time to spontaneous labour onset and delivery; induction-to-delivery intervals; biomarker changes from term to post-term. In spontaneous labour, higher sFlt-1 levels and sFlt-1/PlGF ratios were inversely correlated with time to delivery (both p = 0.03). The sFlt-1/PlGF ratio remained independently associated with shorter time to delivery after adjustment for gestational age, maternal body mass index, and parity. In induced labour, higher PlGF levels were associated with longer induction-to-delivery intervals (p = 0.02). From term to post-term, PlGF declined (median 208 vs. 148 pg/mL, p < 0.0001), whereas sFlt-1 (median 3128 vs. 3631 pg/mL) and the sFlt-1/PlGF ratio (14 vs. 24) increased (both p < 0.0001). In low-risk term pregnancies, an anti-angiogenic profile is associated with shorter time to spontaneous delivery and increases from term to post-term consistent with physiological placental maturation. In induced labour, biomarkers reflect placental state but do not independently predict induction dynamics. Their potential role in late-term risk assessment warrants further investigation.
To evaluate whether the IOTA ADNEX model and the Two-Step Strategy improve triage and referral of adnexal masses in routine gynaecologic care compared with the RMI and to identify an appropriate malignancy-risk threshold. Prospective multicenter cohort study. Thirteen non-tertiary hospitals and clinics and one tertiary referral hospital in Denmark. A complete-case cohort of 966 patients with adnexal masses. Malignancy risk was estimated using prospectively collected clinical data, ultrasound findings, and CA125 levels. Reference standard was histopathology or ≥ 12 months of clinical follow-up. Performance was evaluated across predefined thresholds (1%-30% for ADNEX/Two-Step Strategy (modified benign descriptors + ADNEX); ≥ 200 for RMI), stratified by centre type. Negative and positive predictive values (NPV, PPV), sensitivity, referral rates to assess correct and incorrect referrals. In non-tertiary centres, NPVs were ≥ 96% for IOTA models versus 95% for RMI; corresponding values in the tertiary centre were 82%-100% versus 78%. PPVs increased with higher thresholds and approached RMI at 20% threshold. In non-tertiary centres, where referral decisions are made, a 15% threshold provided the most favourable balance between sensitivity (~63%) and referral rate (~14%). At thresholds ≥ 25%, referral rates were similar to RMI (~8%), with only marginal gains in sensitivity (~50% vs. 39%). Most additionally detected tumours were stage I ovarian cancers or borderline tumours. For masses classified as benign by modified benign descriptors, ADNEX showed high NPVs but low PPVs and negligible net benefit, providing limited additional diagnostic value over the Two-Step Strategy. IOTA-based models improve early detection but increase referral rates. A 15% risk threshold appears to offer a clinically reasonable balance between early detection of malignancy and referral burden, based on observed trade-offs between detection and referral rates. ClinicalTrials.gov identifier: NCT04188652.
Development and validation of two prediction models for obstetric anal sphincter injury (OASI). Population-based cohort study. Nationwide (the Netherlands). Data from the Netherlands Perinatal Registry, describing nulliparous women who delivered a singleton live born infant in cephalic presentation at term from 2016 to 2020, with spontaneous (SVD) or operative vaginal delivery (OVD). Based on literature and clinical expertise, a set of potential predictors was defined and derived from the national perinatal registry. A predictive model was constructed, and accessible nomograms provided. Internal and temporal external validation was performed. OASI rate. The risk of OASI in 171 046 women with SVD was 4.1%. After logistic regression with step-wise backward selection using Akaike Information Criterion (AIC), ten predictors were retained. These were: mediolateral episiotomy (MLE), expected fetal birth weight, duration of the 2nd stage, occipitoposterior presentation, induction of labour, epidural analgesia, Asian ethnicity, maternal age, gestational age and fetal sex. The final model had a moderate discriminative ability (AUC 0.67, 95% CI 0.67-0.68) and excellent calibration (Brier score 0.039). The average risk of OASI in 37 547 women with OVD was 3.5%. Seven predictors were retained in the model: MLE, expected fetal birth weight, duration 2nd stage of labour, occipitoposterior fetal presentation, epidural analgesia, Asian ethnicity and gestational age. The final model had moderate discrimination (AUC 0.68, 95% CI 0.67-0.70) and excellent calibration (Brier score 0.032). A prediction model for OASI was developed and validated for both nulliparous women with spontaneous vaginal delivery and with operative vaginal delivery. These models can form a basis to identify women with a high risk of OASI.
To describe pregnant individuals with blood lead levels (BLLs) ≥ 45 mcg/dL and their pregnancy outcomes to inform clinical practice and public health policy. Inclusion criteria required New York City (NYC) residence and a venous BLL ≥ 45 mcg/dL during pregnancy. BLL data were linked to case events notes, risk assessment findings, and newborn data. NYC, 2004 to 2023. Pregnant individuals with BLLs ≥ 45 mcg/dL. Characteristics of pregnant individuals and pregnancy outcomes were summarised using descriptive statistics. Birth outcomes were compared with WHO standards and across trimesters of referral. Fisher's exact and Z tests were used to assess the significance of differences. Demographic characteristics, pregnancy outcome data, chelation of mother, and chelation of newborn. There were 44 pregnant individuals identified with BLLs ≥ 45 mcg/dL during pregnancy. The majority of cases were foreign-born, with 52% from Mexico and 25% from South Asia. The miscarriage rate (9%) was more than twice the citywide rate. Potential lead sources varied by region, with 50% from Mexico and the Caribbean reporting pica, and 71% from India using traditional remedies. Cases identified earlier were more likely to have newborns with BLLs ≤ 10 mcg/dL and less likely to require chelation. Those treated with CaNa2EDTA alone had newborns with significant BLL declines. For the newborns, the prevalence of birth lengths and head circumferences below 5% was higher than expected, and if chelated, the BLL took about 27 months to decline < 5 mcg/dL. Cultural practices, pica, and using traditional remedies were frequently identified in pregnant individuals with BLLs ≥ 45 mcg/dL.
This study identifies specific language used for common problems seen in gynaecology. To better identify language used by patients for gynaecological conditions and understand how these terms may differ between communities. Observational qualitative study. An urban academic hospital. Adult female patients (aged 18 and older) seen in the gynaecology clinic were included, and those younger than 18 and non-English speakers were excluded. Interviews using a structured interview guide were conducted. New patients were enrolled in the study until the point of theoretical saturation. Key terms were identified and trends involving symptoms were investigated using natural language processing (NLP) techniques including lemmatization, text similarity and sentiment. Terminology gathered from study interviews was described. Thirty patients completed the study. Study participants included 12 (40%) Black patients, 9 (30%) White, 4 (13.3%) Hispanic and 3 (10.3%) Asian. Participants were equally distributed in age and most participants had attended some college 26 (86.6%). Almost half of the women had not been pregnant, 14 (46.7%). While many patients used some medical specific terminology, many also used symptoms specific common terms that were more descriptive of their experience. Patients identified 'cysts' more commonly than 'fibroids' and were concerned about cancer. Overwhelmingly patients identified communication problems between providers and patients resulting in misunderstandings and a lack of trust. By starting with identifying specific language used and expanding to identifying overall themes, we can improve understanding between patients and providers.
To explore the characteristics of symptom flares, individual experiences and behaviours during flares in people with endometriosis. Online questionnaire shared on patient support sites. People with a confirmed or working diagnosis of endometriosis (a working diagnosis is given by clinicians based on symptoms/history; individuals may or may not go on to have further imaging/surgical investigations). A total of 236 responses were collected. Descriptive and comparative analysis of quantitative data, and thematic analysis of qualitative data. The characteristics, triggers, treatments and strategies for symptom flares together with perceived predictability and self-efficacy in relation to flares, healthcare access during flare, advice received and overall endometriosis-related quality-of-life. We identified a wide variation in the characteristics and treatments/strategies. 31.2% stated that they were 'not at all' confident coping with long flares, and around 1/3 of participants found flares 'not at all' predictable. Only 35.3% reported receiving advice from a healthcare provider about flares. We developed 5 themes to suggest why participants did not contact healthcare providers: 'what can they do?', 'I can cope, it will end', 'broken healthcare system', 'perceived dismissal and gaslighting' and 'symptoms stop me'. Flares have a large impact on quality-of-life and are clinically very important. Individuals do not commonly receive advice from healthcare providers or contact healthcare providers during a flare. More research, in a more diverse sample, is needed to identify mechanisms underlying flares, as well as developing and disseminating management tools to prevent, manage and treat flares.
To evaluate the association between prenatal exposure to opioids analgesics and academic performance in third grade children. Population-based cohort study using linked data from New South Wales birth records, medicine dispensing data, and national standardised test results. New South Wales, Australia (2003-2011). Liveborn children of concessional women, excluding those whose mothers lived interstate, were overseas visitors, or had records of opioid dependence. Exposure was defined as ≥ 1 opioid dispensed during pregnancy stratified by pregnancy timing, dose, and type of monotherapy. Reading and numeracy z-scores were compared between children with and without prenatal opioid exposure using linear mixed-effects models incorporating propensity score weights and accounting for maternal and school clustering. Standardised national reading and numeracy Z-scores for third-grade children. Among 85,478 eligible children, 70,882 (82.9%) had test scores, with 7,664 (10.2%) prenatally exposed to opioids analgesics, mainly codeine. Prenatal e.xposure to opioid analgesics was associated with a slight decrease in standardised reading and numeracy test scores (adjusted mean difference [aβ] -0.05, 95% CI -0.06 to -0.03), below the conventional threshold for a small effect (Cohen's d = 0.2). Codeine and oxycodone results were similar to those for any opioid exposure, while a larger difference was observed for tramadol (reading aβ -0.25, 95% CI -0.31 to -0.18; numeracy aβ -0.22, 95% CI -0.29 to -0.16). Prenatal exposure to codeine and oxycodone do not have meaningful impacts on third-grade academic performance. In contrast, tramadol was associated with lower reading and numeracy scores, though whether this reflects a true effect or is attributable to unmeasured confounding remains unclear and warrants further investigation.