Background:For women with chronic or gestational hypertension who remain well, early term birth (at 37-38 weeks' gestation) may reduce maternal complications, caesareans and stillbirths, but it may increase neonatal morbidity compared with expectant care. Expectant care may increase costs. There are no high-quality data to guide care, which currently involves maternal-fetal surveillance and intervention for maternal or fetal compromise, which may be rapid or unexpected. Objective:To investigate optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well. Design:Pragmatic, unmasked, multicentre randomised trial with a health economic analysis. Setting:Fifty United Kingdom hospitals. Participants:Inclusion: maternal age ≥ 16 years, chronic or gestational hypertension, singleton pregnancy, live fetus, 36+0-37+6 weeks' gestation and able to give documented informed consent. Exclusion: contraindication to either trial arm (e.g. pre-eclampsia), blood pressure ≥ 160/110 mmHg until controlled, major fetal anomaly anticipated to require neonatal care unit admission or participation in another timed birth trial. Interventions:Planned early term birth at 38+0-3 weeks' (intervention) or 'usual care at term' (control, revised from 'expectant care until at least 40+0 weeks', August 2022). Main outcome measures:Maternal coprimary: composite of 'poor maternal outcome' (severe hypertension, maternal death or maternal morbidity and superiority hypothesis). Neonatal coprimary: neonatal care unit admission ≥ 4 hours (non-inferiority hypothesis). Each coprimary is measured until primary hospital discharge or 28 days post birth (whichever is earlier). Key secondary: caesarean birth. Randomisation:1 : 1 ratio, minimised for key prognostic variables: site, hypertension type and prior caesarean. Blinding:It was not possible to mask care providers or participants to the intervention. For the coprimary maternal outcome, there was local site principal investigator/delegate sign-off based on review, masked to allocated group, of primary case notes. Results:From 2019 to 2022, 403 participants were randomised (37% of target 1080) to intervention (n = 201) or control (n = 202). The funder stopped the trial during the coronavirus disease discovered in 2019 pandemic for delayed recruitment. In the intervention (vs. control) group, birth was a median of 0.9 weeks earlier (38.4, interquartile range 38.3-38.6 vs. 39.3, interquartile range 38.7-39.9 weeks). There was no evidence of a difference in 'poor maternal outcome' (13% vs. 12%, respectively; adjusted risk ratio 1.16, 95% confidence interval 0.72 to 1.87). For 'neonatal care unit admission ≥ 4 hours', the intervention was considered to be non-inferior to control, as the adjusted risk difference, 95% confidence interval upper bound did not cross the 8% pre-specified non-inferiority margin (7% vs. 7%, respectively; adjusted risk difference 0.003, 95% confidence interval -0.05 to +0.06), although event rates were lower than estimated. There was no evidence of a difference in caesarean (29% vs. 36%, respectively; adjusted risk ratio 0.81, 95% confidence interval 0.61 to 1.08). Limitations:Recruitment was 37% of the anticipated sample size (as above). Conclusions:Despite being unable to recruit to target in this study, we observed that most women with chronic or gestational hypertension required labour induction and planned birth at 380-3 weeks (vs. usual care), which resulted in birth an average of 6 days earlier and there were no differences in poor maternal outcome or neonatal morbidity. Our findings provide reassurance about planned birth at 380-3 weeks as a clinical option for these women. Future work:An individual participant data meta-analysis is planned to address whether the intervention (vs. control) reduces caesarean; low adverse event rates would make unfeasible mounting another randomised trial. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/167/123.

Background:We tested whether COVID-19 vaccination affects the risk of preeclampsia (PE) given the well-documented association between COVID-19 and PE, and their overlapping risk factors and pathophysiological pathways. Methods:We analysed individual level data from pregnant women prospectively enrolled from 18 countries in two consecutive cohorts between 2020 and 2022 during the COVID-19 pandemic using identical methodology. Pregnant women were recruited either with a COVID-19 diagnosis or as concomitant, consecutive, non-diagnosed controls from the same hospitals. Following vaccine availability, vaccination status was documented to define a vaccine-exposed subgroup. Multivariable logistic regression models assessed the odds of PE adjusting for confounders and cohort as a proxy for viral strain, stratifying by pre-existing morbidities and SARS-CoV-2 infection. Survival analyses estimated PE incidence according to vaccination status and pre-existing morbidities. Findings:Of 6527 pregnant women, 2166 (33.2%) were diagnosed with COVID-19 and 3753 (57.5%) were unvaccinated. Of the 2774 vaccinated women, 1795 (64.7%) received mRNA vaccines; 848 (30.6%) received the initial regimen plus a booster dose, of whom 66.6% received a booster with an mRNA vaccine. We confirmed an independent association between COVID-19 and PE (aOR: 1.45; 95% CI: 1.15-1.84), particularly in unvaccinated women (aOR: 1.78; 95% CI: 1.31-2.42). Overall, after adjusting for confounders, any vaccination gave a protective effect against PE during the index pregnancy (aOR: 0.85; 95% CI: 0.65-1.10), that was stronger with a booster dose (aOR: 0.67; 95% CI: 0.45-0.99). Among women with pre-existing morbidities who received a booster dose the odds were reduced by 58% (aOR: 0.42; 95% CI: 0.20-0.87) - an effect mainly observed in women diagnosed with COVID-19. Adjustment for study site and cohort year did not alter the magnitude of the effect. Vaccination amongst women who received a booster dose was also associated with decreased odds of maternal (aOR: 0.68; 95% CI: 0.55-0.83) and perinatal (aOR: 0.71; 95% CI: 0.54-0.95) morbidity and mortality, and preterm birth (aOR: 0.67; 95% CI: 0.53-0.85). Interpretation:COVID-19 vaccination with a booster reduces the odds of PE by 30% approaching 60% reduction among women with pre-existing morbidities. Funding:The original INTERCOVID study was supported in Oxford by the COVID-19 Research Response Fund from the University of Oxford (Ref 0009083).

Introduction It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy.Methods and analysis Cluster randomised trial.Sites and participants 320 000 women from up to 80 hospital maternity units.Strategies Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design.Outcomes The primary outcome is all-cause early (<7 days of birth) neonatal sepsis, defined as either a positive blood/cerebrospinal fluid culture, early neonatal death from infection or a negative/unknown culture status with ≥3 agreed clinical signs or symptoms, who receive intravenous antibiotics ≥5 days. All women giving birth ≥24 weeks’ gestation, regardless of mode of birth, and all her babies will be included in the dataset. Cost-effectiveness will be expressed in terms of incremental cost per case of early neonatal sepsis avoided and incremental cost per quality-adjusted life-year associated with each strategy.Ethics and dissemination The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19/EM/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment.Trial registration number ISRCTN49639731.

OBJECTIVES:No published methods for research integrity review include both statistical techniques applied to groups of randomized trials and individual assessment of papers. We propose a method based on practical experience of investigating data integrity across the collected papers of an author or author group. STUDY DESIGN AND SETTING:We report our approach to investigating the collected papers of an author or author group suspected of academic misconduct. RESULTS:In the investigation of the work of an author or author group, we recommend a systematic search for the work of the involved authors in PubMed, Google Scholar, and the Retraction Watch database, as well as a search of trial registries for unpublished clinical trials. Summary information from studies should be tabulated to assess consistency between study registration, execution, and publication. Each paper should be investigated for unfeasible features of the governance, methodology, execution, results, and reporting of the study. Pairwise comparison of baseline and outcome tables between papers may reveal data duplication or unfeasibly large differences between baseline characteristics in similar studies. Assessment of baseline characteristics from multiple randomized trials using Carlisle's method can determine whether the data are consistent with a properly executed randomization process, as can checking whether reported baseline characteristics follow expected patterns for random variables such as Benford's law. If serious concerns are raised, a more thorough investigation should be performed by journals, publishers, and institutions. CONCLUSION:These methods provide a systematic and reproducible way to assess the collected work of an author or group of authors. PLAIN LANGUAGE SUMMARY:It is increasingly accepted that papers reporting on clinical studies may contain fraudulent or falsified data, often multiple papers by a single author or author group. Based on our experience assessing the research integrity of collections of papers by one author or author group, we present an approach to these investigations that combines published statistical methods with pragmatic assessment of study feasibility. This will help journals and publishers better identify groups of potentially untrustworthy studies.

Introduction Excessive bleeding after childbirth (postpartum haemorrhage, PPH) affects 5% of births and causes 75 000 maternal deaths worldwide annually. It is the leading cause of direct maternal deaths globally and continues to be a major cause of mortality in the UK. Oxytocin is the standard first-line treatment for atonic PPH. The PPH rate is increasing, and this may be partially related to the overuse of oxytocics in labour. Laboratory studies on myometrium suggest that repeated use of oxytocics leads to the saturation of oxytocin receptors and reduced therapeutic efficacy of oxytocin. Carboprost (a prostaglandin analogue) is usually reserved for second-line management of atonic PPH. A systematic review comparing the efficacy of carboprost and conventional uterotonics for PPH prophylaxis found that carboprost was associated with less blood loss, but around 15% of women experienced side effects. The study’s aim is to compare intramuscular carboprost with intravenous oxytocin for the initial treatment of PPH. In addition, to assess the cost-effectiveness of both treatments, participants’ views on the two treatments and the consent process.Methods and analysis COPE is a double-blind, double-dummy, randomised controlled trial that aims to recruit 2000 women (1:1 allocation, stratified by mode of birth) across 20 hospitals in the UK. Due to the emergency nature of PPH, COPE uses a research without prior consent (RWPC) model. Randomisation and treatment will occur if eligibility criteria are met once bleeding starts. Postnatal consent will be sought for disclosure of identifiable data and continued follow-up. Clinical efficacy outcomes will be collected at 24 and 48 hours or at hospital discharge, if sooner. Questionnaires will also be collected at 24 hours and 4 weeks postrandomisation. Cost-effectiveness will be based on the incremental cost per quality-adjusted life-year, calculated from the perspective of the NHS and personal social services.Ethics and dissemination This study has been approved by the Coventry and Warwickshire Research Ethics Committee (REC) (18/WM/0227) and the Health Research Authority. Results will be disseminated via peer-reviewed publications.Trial registration number ISRCTN16416766.

ObjectiveComprehensive investigation of published work by authors suspected of academic misconduct can reveal further concerns. We aimed to test for data integrity concerns in papers published by an author with eight retracted articles.Study designWe investigated the integrity of all papers reporting on prospective clinical studies by this author. We assessed the feasibility of study methods, baseline characteristics, and outcomes. We plotted the author's clinical research activity over time. We conducted pairwise comparisons of text, tables, and figures to identify duplicate publications, and checked for consistency between conference abstracts, interim analyses, trial registrations, and final papers. Where indicated, we recalculated p-values from the reported summary statistics.ResultsWe identified 263 papers claiming to have enrolled 74,667 participants between January 2009 and July 2022, 190 (72%) of which reported on studies that recruited from the Assiut Women's Health Hospital in Assiut, Egypt. The number of active studies per month was greatest between 2016 and 2019, with 88 ongoing studies in May 2017. We found evidence of data integrity concerns in 130 (49%) papers, 43 (33%) of which contained concerns sufficient to suggest that they could not be based on data reliably collected from human participants.ConclusionOur investigation finds evidence of widespread integrity concerns in the collected work of one author. We recommend that the involved journals collaborate in a formal investigation.

OBJECTIVE:Potentially untrustworthy medical research is often identified after publication. We evaluated the effectiveness and efficiency of post-publication review of such studies in women's health. DESIGN:Cohort study. SAMPLE:Potentially untrustworthy papers published in women's health journals. METHODS:We wrote to the editors and publishers about potentially untrustworthy papers in women's health and requested an investigation according to the procedure established by the Committee of Publication Ethics (COPE). MAIN OUTCOME MEASURE:Study characteristics, investigation outcome classed as retraction, expression of concern (EoC), correction or no wrongdoing found, and time to decision. We also report the case completion rate per journal and publisher. RESULTS:Between 7th November 2017 and 30th April 2024, we wrote to editors and publishers of 891 potentially untrustworthy papers published in 206 different journals. At present, 263 (30%) of 891 papers received an outcome, with 227 (86%) labelled as problematic [152 (58%) retracted; 75 (29%) EoC]. For articles with a decision, it took a median time of 38 months for editors and publishers to decide, with 13% of the flagged cases reaching a decision within 12 months. CONCLUSIONS:The current PPR process is inefficient and ineffective in assessing and removing untrustworthy data from the medical literature.

Background:In the United Kingdom, pregnant women are offered two scans: at 11-14 and 18-20 weeks' gestation. Current guidance supports fetal anatomical screening at the second scan, but evidence suggests earlier detection is possible. Objectives:To determine clinical and cost-effectiveness of a detailed two-dimensional ultrasound scan in the first trimester for detection of fetal anomalies, in addition to usual practice. Design:Systematic review and meta-analysis. Nationwide survey. Analysis of National Congenital Anomaly Disease Registry data. Consensus procedure. Prospective survey of parental opinions. Probabilistic decision-analytic model for cost-effectiveness. Value-of-information analysis. Setting:United Kingdom National Health Service. Participants:Pregnant women and partners. Interventions:Detailed anomaly ultrasound at 11-14 weeks' gestation, in addition to usual practice. Main outcome measures:Diagnostic accuracy, protocol development, health economic modelling and value-of-information analysis. Data sources:MEDLINE (OvidSP), EMBASE (OvidSP), Science Citation Index and Conference Proceedings Citation Index-Science (Web of Science Core Collection); National Congenital Anomaly Disease Registry; European Congenital Anomalies Registry; Surveys of National Health Service Trusts; screening sonographers, midwives and doctors; and parents; National Schedule of National Health Service Costs (2019-20). Review methods:Systematic review and meta-analysis for diagnostic accuracy. Results:First-trimester ultrasound detects 93.3% (95% confidence interval 90.4% to 95.7%) of a pre-selected group of eight major anomalies with specificity of 99.99% (95% confidence interval 99.98% to 99.99%) and positive predictive value of 96.5% (95% confidence interval 93.3 to 98.8, 416,877 fetuses, 40 studies). For major cardiac anomalies, the respective data are 55.8% (95% confidence interval 45.9% to 65.5%), 99.98% (95% confidence interval 99.97% to 99.99%) and 94.85% (95% confidence interval 91.63% to 97.32%, 306,872 fetuses, 45 studies). Of NHS trusts surveyed, 77% currently perform first-trimester anatomy assessment, with evidence of inequity of care; earlier screening resulted in more diagnoses before 16 weeks' gestation. A consensus procedure (n = 172) developed an anatomical protocol and minimum targets for diagnosis. Parental survey (n = 1374) indicated that over 90% would opt for such screening. Modelling of singleton pregnancies undergoing earlier anomaly screening using two-dimensional ultrasound was associated with increased mean healthcare costs per woman (£11, 95% confidence interval £1 to £29) and maternal quality-adjusted life-years (0.002065, 95% confidence interval 0.000565 to 0.00358), an incremental cost per quality-adjusted life-year of £5270, with likelihood of being cost-effective at £20,000 per quality-adjusted life-year of over 95%. Additional modelling predicted reductions in infant healthcare costs and quality-adjusted life-years. Decision uncertainty was low. Value-of-information analysis of cost-effectiveness results showed no groups of parameters for which further research to reduce uncertainty would likely prove cost-effective. Limitations:Study heterogeneity; the lack of a universal reference standard; simplifying assumptions relating to economic model structure; and estimation of some parameters are documented and justified. The rarity of the conditions made estimation of longer-term maternal and infant costs and quality-adjusted life-years challenging, resulting in likely under-estimation of healthcare costs. Conclusions:With standardisation and training, first-trimester ultrasound screening for fetal anomalies is clinically effective with over 90% detection for eight major conditions and low false-positive rates. Decision uncertainty around implementation is low and a prospective study would not be an efficient investment. Adding first-trimester anomaly screening to the current screening likely represents a cost-effective use of resources and is acceptable to parents. Future work:Focus on developing an implementation framework to modify the current United Kingdom Fetal Anomaly Screening Programme. Study registration:This study is registered as PROSPERO CRD42018111781 and CRD42018112434. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/19/10) and is published in full in Health Technology Assessment; Vol. 29, No. 22. See the NIHR Funding and Awards website for further award information.

INTRODUCTION:Induction of labor (IOL) is a common intervention in industrialized countries. Failed induction is frequently reported, yet there is no consensus on its definition. Since the primary goal of IOL is to initiate labor, progress to the active phase is a more relevant measure of success than the surrogate of caesarean birth. Previous studies on the influence of body mass index (BMI) on the risk of failed IOL are limited. Most rely on data from the United States and define failed IOL primarily by caesarean delivery. This study aims to explore the association between maternal BMI and failed IOL, defined as failure to progress to the active phase of labor. MATERIAL AND METHODS:We studied 22 114 term, singleton women undergoing IOL in the Central Denmark Region from 2013 to 2022. Women with spontaneous prelabor rupture of membranes, uterine scar, or fetal demise were excluded. The main outcome measure was failed IOL, defined as not reaching cervical dilation of 6 cm or more. BMI, our exposure, was modeled as a continuous variable using restricted cubic splines and as a categorical variable stratified according to the World Health Organization BMI groups. Adjusted logistic regression was used in both models to assess the association between BMI and failed IOL. RESULTS:Proportions of nulliparous women with failed IOL ranged between 4% for normal weight and 10% for obesity class III. Adjusted odds ratios for nulliparous women for failed IOL were 1.5 (95% confidence intervals [CI] 1.3, 1.7) for overweight, 1.8 (95% CI 1.4, 2.3) for obesity class I, 2.7 (95% CI 2.2, 3.3) for obesity class II, and 2.9 (95% CI 1.4, 6.0) for obesity class III compared to women with normal weight. In parous women, there was a similar but less pronounced association between BMI and failed IOL with a <2% absolute risk of failed IOL. A similar pattern was found when BMI and failed IOL were modeled using restricted cubic splines. CONCLUSIONS:In singleton women with induced labor at term, increasing BMI was associated with higher odds of failed IOL; this association was more pronounced in nulliparous women.

( BJOG . 2024;131(5):568–578. https://doi.org/10.1111/1471-0528.17771) The research explores the carbon footprint associated with different childbirth procedures in the UK and the Netherlands, particularly looking at cesarean birth (CB) and vaginal deliveries (VD) in both hospital and home settings. Identifying and reducing high-emission areas, including maternity care, is crucial as health care accounts for about 5% of worldwide greenhouse gas emissions. Using life cycle assessment (LCA), this study offers information on the carbon footprint (a quantitative assessment of greenhouse gas emissions attributed to an occurrence and expressed in CO 2 e) associated with childbirth so that maternity health care professionals can make environmentally conscious choices.

BACKGROUND:Oral iron for anaemia in pregnancy is often not well tolerated, with poor adherence. Iron administered intravenously might address these tolerance and adherence issues. We investigated the effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate on anaemia and iron deficiency among pregnant women in Nigeria. METHODS:We did a multicentre, open-label, parallel, randomised controlled trial of pregnant women (aged 15-49 years) with haemoglobin (Hb) concentrations of less than 10 g/dL at 20-32 weeks' gestation from 11 primary, secondary, or tertiary health facilities in Nigeria (five in Lagos and six in Kano). Exclusion criteria included vaginal bleeding, blood transfusion or major surgery within the past 3 months, symptomatic anaemia, anaemia known to be unrelated to iron deficiency, clinically confirmed malabsorption syndrome, previous hypersensitivity to any form of iron, pre-existing maternal depression or other major psychiatric illness, immune-related diseases, such as systemic lupus erythematosus or rheumatoid arthritis, or severe allergic reactions. Participants were randomly assigned (1:1) by nurses and doctors using a web-based randomisation service to either receive a single dose of intravenous ferric carboxymaltose (20 mg/kg to a maximum of 1000 mg) or oral ferrous sulphate (200 mg; 65 mg elemental iron) three times daily until 6 weeks postpartum. The study was primarily unmasked. Primary outcomes were maternal anaemia (Hb <11 g/dL) at 36 weeks' gestation and preterm birth at before 37 weeks' gestation, with analysis by intention to treat in participants with available data. This study was registered at the ISRCTN registry on Dec 10, 2020 (ISRCTN63484804) and on ClinicalTrials.gov (NCT04976179) on April 7, 2021. FINDINGS:Between Aug 10, 2021, and Dec 15, 2022, 13 724 pregnant women were screened for eligibility. 12 668 were excluded due to ineligibility for inclusion, and 1056 provided consent to participate and were randomly assigned to either the intravenous or oral administration groups. 527 were assigned to the intravenous ferric carboxymaltose group and 529 were assigned to the oral ferrous sulphate group. 518 in the intravenous group were assessed at 36 weeks' gestational age and after 518 deliveries, and 511 completed the 6 weeks postpartum visit. 513 in the oral ferrous sulphate group were assessed at 36 weeks' gestational age and after 512 deliveries, and 501 completed the 6 weeks postpartum visit. No significant difference was found in anaemia at 36 weeks (299 [58%] of 517 in the intravenous group vs 305 [61%] of 503 in the oral group; risk ratio 0·95, 95% CI 0·85-1·06; p=0·36), nor in preterm birth (73 [14%] of 518 vs 77 [15%] of 513; 0·94, 0·70-1·26; p=0·66). There were no significant differences in adverse events. The most common adverse events were diarrhoea (in six participants) and vomiting (in three participants) in the oral group and fatigue (in two participants) and headache (in two participants) in the intravenous group. INTERPRETATION:Although the effect on overall anaemia did not differ, intravenous iron reduced the prevalence of iron deficiency to a greater extent than oral iron and was considered to be safe. We recommend that intravenous iron be considered for anaemic pregnant women in Nigeria and similar settings. FUNDING:Bill & Melinda Gates Foundation.

To investigate whether endometrial pattern on ultrasound can predict the outcome of in vitro fertilisation (IVF) or intracytoplasmic injection (ICSI). 155 women took part in this prospective study. This included 116 fresh and 75 frozen cycles. Four grade endometrial pattern classification system was used. Pattern 1 (triple), pattern 2 (early intermediate), pattern 3 (late intermediate) and pattern 4 (homogenous). Endometrial pattern was recorded at trigger, oocyte retrieval and embryo transfer for fresh cycles. For frozen cycles, endometrial pattern was recorded at day 15 of the cycle and at embryo transfer. The odds of clinical pregnancy in the homogenous group was less likely when compared to the triple group OR is 0.05 with 95%CI (0.0027 to 1.05) and less likely for the late intermediate group in comparison to the triple pattern OR 0.65 (0.21 to 1.98), p value = 0.009. The odds of becoming pregnant with homogenous pattern at embryo transfer was three times higher than early intermediate. Similarly, women with late intermediate pattern were 6 times more likely to become pregnant than women with early intermediate at embryo transfer p value is <0.05. The odds of having livebirth with homogenous pattern at embryo transfer is higher than early intermediate OR 1.79 with 95% CI (0.08 to 40.82). Similarly, women with late intermediate pattern were almost 5 times more likely to become pregnant than women with early intermediate at embryo transfer. Women with a homogenous pattern or late intermediate pattern at egg collection were less likely to have clinical pregnancy when compared to women with a triple pattern. Women with homogenous and late intermediate pattern at embryo transfer were more likely to have livebirth compared to women with early intermediate pattern. However, there are some limitations and large randomised controlled trials are needed to validate these results.

BACKGROUND: In early 2023, when Omicron was the variant of concern, we showed that vaccinating pregnant women decreased the risk for severe COVID-19-related complications and maternal morbidity and mortality. OBJECTIVE: This study aimed to analyze the impact of COVID-19 during pregnancy on newborns and the effects of maternal COVID-19 vaccination on neonatal outcomes when Omicron was the variant of concern. STUDY DESIGN: INTERCOVID-2022 was a large, prospective, observational study, conducted in 40 hospitals across 18 countries, from November 27, 2021 (the day after the World Health Organization declared Omicron the variant of concern) to June 30, 2022, to assess the effect of COVID-19 in pregnancy on maternal and neonatal outcomes and to assess vaccine effectiveness. Women diagnosed with laboratory-confirmed COVID19 during pregnancy were compared with 2 nondiagnosed, unmatched women recruited concomitantly and consecutively during pregnancy or at delivery. Mother-newborn dyads were followed until hospital discharge. The primary outcomes were a neonatal positive test for COVID-19, severe neonatal morbidity index, severe perinatal morbidity and mortality index, preterm birth, neonatal death, referral to neonatal intensive care unit, and diseases during the neonatal period. Vaccine effectiveness was estimated with adjustment for maternal risk profile. RESULTS: We enrolled 4707 neonates born to 1577 (33.5%) mothers diagnosed with COVID-19 and 3130 (66.5%) nondiagnosed mothers. Among the diagnosed mothers, 642 (40.7%) were not vaccinated, 147 (9.3%) were partially vaccinated, 551 (34.9%) were completely vaccinated, and 237 (15.0%) also had a booster vaccine. Neonates of booster- vaccinated mothers had less than half (relative risk, 0.46; 95% confidence interval, 0.23-0.91) the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers; they also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death (relative risk, 2.06; 95% confidence interval, 1.06-4.00) when compared with those of nondiagnosed mothers. Vaccination was not associated with any congenital malformations. Although all vaccines provided protection against neonatal test positivity, newborns of booster-vaccinated mothers had the highest vaccine effectiveness (64%; 95% confidence interval, 10%-86%). Vaccine effectiveness was not as high for messenger RNA vaccines only. Vaccine effectiveness against moderate or severe neonatal outcomes was much lower, namely 13% in the booster-vaccinated group (all vaccines) and 25% and 28% in the completely and booster-vaccinated groups, respectively (messenger RNA vaccines only). Vaccines were fairly effective in protecting neonates when given to pregnant women <100 days (14 weeks) before birth; thereafter, the risk increased and was much higher after 200 days (29 weeks). Finally, none of the neonatal practices studied, including skin-to-skin contact and direct breastfeeding, increased the risk for infecting newborns. CONCLUSION: When Omicron was the variant of concern, newborns of unvaccinated mothers had an increased risk for neonatal death. Neonates of vaccinated mothers had a decreased risk for preterm birth and adverse neonatal outcomes. Because the protective effect of COVID-19 vaccination decreases with time, to ensure that newborns are maximally protected against COVID-19, mothers should receive a vaccine or booster dose no more than 14 weeks before the expected date of delivery.

Objectives: To establish if routine 3D/4D ultrasound scan is a feasible diagnosis in congenital M üllerian anomalies and to evaluate the impact of ultrasound guidance during hysteroscopic procedures for those anomalies.Methods: We conducted a retrospective study including the hysteroscopic procedures performed in our unit in the last 5 years for M üllerian Duct Congenital anomalies (MCDA).There were 2 study groups one performed under ultrasound guidance and the other without ultrasound assistance.We evaluated the time, the incidence of complications, and the post procedural results in both groups.Results: In the last five years we performed 175 hysteroscopic procedure from which 16 were for MCDA, in 11 cases the type was U2a, and in six cases U2b.The ultrasound-guided procedures were

Objective: To compare the carbon footprint of caesarean and vaginal birth. Design : Life cycle assessment. Setting : Tertiary maternity units and home births in the UK and the Netherlands Methods: A life cycle assessment, including: equipment use, energy, analgesia, hospital stay, waste, sterilisation and laundry, was conducted using primary data combined with data from published sources. Main Outcome Measures: ‘Carbon footprint’ (in kgCO e) Results: Excluding analgesia, the carbon footprint of a caesarean birth in the UK was 31.21 kgCO e, compared with 12.47 kgCO e for vaginal birth in hospital and 7.63 kgCO e at home. In the Netherlands the carbon footprint of a caesarean was higher (32.96 kgCO e), but lower for vaginal birth in hospital and home (10.74 and 6.27 kgCO e respectively). Emissions associated with analgesia for vaginal birth were: 0.08 kgCO e (opioid analgesia), 0.75 kgCO e (remifentanil), 1.2 kgCO e (epidural) and 237.33 kgCO e (nitrous oxide with oxygen). Differences in analgesia use resulted in a lower average carbon footprint for vaginal birth in the Netherlands than the UK (11.64 vs. 193.26 kgCO e). Conclusion: The carbon footprint of a caesarean is higher than for vaginal birth if analgesia is excluded, but this is very sensitive to the analgesia used; use of nitrous oxide with oxygen multiplies the carbon footprint of vaginal birth 25-fold. Alternative methods of pain relief or nitrous oxide destruction systems would lead to a substantial improvement in carbon footprint. Although clinical need and maternal choice are paramount, protocols should consider the environmental impact of different choices.