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We aimed to evaluate the incidence of undiagnosed abnormal postpartum blood loss (UPPBL) after vaginal delivery, identify the risk factors and compare them to those of postpartum haemorrhage (PPH). The study population included women who participated in a randomized controlled trial of women with singleton low-risk pregnancy who delivered vaginally after 35 weeks' gestation (n = 3917). Clinical PPH was defined as postpartum blood loss ≥ 500 mL measured by using a collector bag and UPPBL was defined by a peripartum change in haemoglobin ≥ 2 g/dL in the absence of clinical PPH. Risk factors were assessed by multivariate multinomial logistic regression. The incidence of UPPBL and PPH was 11.2% and 11.0% of vaginal deliveries, respectively. The median peripartum change in Hb level was comparable between UPPBL and PPH groups (2.5 g/dL interquartile range [2.2-3.0] and 2.4 g/dL IQR [1.5-3.3]). Risk factors specifically associated with UPPBL were Asian geographical origin (adjusted OR [aOR] 2.3, 95% confidence interval [CI] 1.2-4.2; p = 0.009), previous caesarean section (aOR 3.4, 2.1-5.5; p<0.001) and episiotomy (aOR 2.6, 1.8-3.6; p<0.001). Risk factors for both UPPBL and PPH were primiparity, long duration of labour, instrumental delivery and retained placenta. Undiagnosed abnormal postpartum blood loss is frequent among women giving birth vaginally and has specific risk factors. The clinical importance of this entity needs further confirmation, and the benefit of systematic or targeted prevention strategies needs to be assessed.

To assess obstetric factors associated with hysterotomy extension among women undergoing a second-stage cesarean. This 5-year retrospective cohort study (2013-2017) included all women with second-stage cesarean deliveries of live-born singleton fetuses in cephalic presentation at term. It took place at a tertiary center that practices delayed pushing. We performed univariable and multivariable logistic regression to assess the maternal, obstetric, and neonatal factors associated with hysterotomy extension mentioned in the surgical report. Operative time, postpartum hemorrhage, and maternal complications were also studied. Of the 3350 intrapartum cesareans, 2637 were performed at term for singleton fetuses in cephalic presentation: 747 (28.3%) during the second stage of labor, 83 (11.1%) of which were complicated by a hysterotomy extension. The median duration of the passive phase of the second stage did not differ between women with and without an extension (164 min versus 160 min, P = 0.85). No other second-stage obstetric characteristics, i.e., duration of the active phase, fetal head station, or fetal malposition, were associated with the risk of extension. Factors significantly associated with extension were the surgeon's experience and forceps use during the cesarean. Women with an extension, compared to women without one, had a longer median operative time (49 min versus 32 min, P<0.001) and higher rates of postpartum hemorrhage and blood transfusion (respectively, 30.1% versus 15.1%, p = 0.002 and 7.2% versus 2.4%, P = 0.03). The risk of a hysterotomy extension does not appear to be associated with second-stage obstetric characteristics, including the duration of the passive phase of this stage. In our center, which practices delayed pushing, prolonging this passive phase beyond 2 hours does not increase the risk of hysterotomy extension in second-stage cesareans.

Although vaccination against influenza is recommended for pregnant women in France because it exposes them to a risk of death and severe respiratory complications, their vaccination coverage in 2016 was estimated at 7%. This study's principal objective was to assess the association between the availability of influenza vaccination at prenatal care visits and vaccination coverage. This multicenter survey took place in 3 Paris-area public hospital (AP-HP) maternity wards (A, B, and C). Only maternity ward A offered the vaccine and vaccination without charge at prenatal visits. Data were collected from parturients during 10 days in January 2017 by a self-administered anonymous questionnaire. Data from 248 women showed overall vaccination coverage of 19.4% (48/248): 35.4% (46/130) in maternity unit A, 2.7% (2/75) in B, and 0% (0/43) in C (P<0.01). After adjustment for socio-demographic characteristics, women at maternity ward A were significantly more likely to be vaccinated than those at B and C (aOR 25.52, 95%CI [5.76-113.10]). Other factors significantly associated with higher vaccination coverage were the mother's French birth (aOR 2.37 CI [1.03-5.46]) and previous influenza vaccination (aOR 3.13, 95%CI [1.25-7.86]). Vaccinated women generally considered they had received adequate information (aOR 4.15 CI [2.10-8.22]), principally from the professional providing their prenatal care. Nonvaccination was attributed to the absence of an offer of vaccination (81.5%), fear of fetal side effects (59.5%), and inadequate information (51.4%). Our results show that availability of influenza vaccination, free of charge, at prenatal consultations at the maternity ward increases vaccination coverage significantly.

Introduction While use of augmentation of labor (AL) is appropriate for labor dystocia, it is frequently used inadequately and unnecessarily. The objective was to assess at a national level, the frequency and determinants of misuse of augmentation of labor (AL). Material and methods Women of the French perinatal survey of 2016 with a singleton cephalic fetus, delivering at term after a spontaneous labor were included. “Misuse of AL” was defined by artificial rupture of the membranes (ROM) and/or oxytocin within one hour of admission and/or duration between ROM and oxytocin of less than one hour. Women, labor and maternity unit’s characteristics were compared between the “misuse of AL” and “no misuse of AL” groups by bivariate analysis. To identify the determinants of misuse of AL, a multivariable multilevel logistic regression was performed taking into account the data’s hierarchical structure (first level: women, second level: maternity units). Results Among the 7196 women included, 1524 (21.2%) had a misuse of AL. The determinants of misuse of AL were middle school educational level (reference high school), aOR = 1.21; 95%CI[1.01–1.45], gestational age at delivery ≥41weeks (reference 39–40 weeks), aOR = 1.19; 95%CI[1.00–1.42], cervical dilation ≥6cm at admission (reference <3cm), aOR = 1.39; 95%CI[1.10–1.76], epidural analgesia aOR = 1.63; 95%CI[1.35–1.96], delivery in a private hospital (reference public teaching hospital), aOR = 2.25; 95%CI[1.57–3.23]; and maternity units with <1000 deliveries/year and 1000–1999 deliveries/year (reference ≥3000 deliveries/year), respectively aOR = 1.52; 95%CI[1.11–2.08] and aOR = 1.42; 95%CI[1.05–1.92]. Less than 3% of the variance was explained by women characteristics, and 24.17% by the maternity units’ characteristics. Conclusions In France, one spontaneous laboring woman among five is subject to misuse of AL. The misuse is mostly explained by maternity unit’s characteristics. The determinants identified in this study can be used to implement targeted actions in small and private maternity units.

Background Oxytocin is effective in reducing labor duration, but can be associated with fetal and maternal complications such as neonatal acidosis and post-partum hemorrhage. When comparing discontinuing oxytocin in the active phase with continuing oxytocin infusion, previous studies were underpowered to show a reduction in neonatal morbidity. Thus, we aim at evaluating the impact of discontinuing oxytocin during the active phase of the first stage of labor on the neonatal morbidity rate. Methods STOPOXY is a multicenter, randomized, open-label, controlled trial conducted in 20 maternity units in France. The first participant was recruited January 17th 2020. The trial includes women with a live term (≥37 weeks) singleton, in cephalic presentation, receiving oxytocin before 4 cm, after an induced or spontaneous labor. Women aged < 18 years, with a lack of social security coverage, a scarred uterus, a multiple pregnancy, a fetal congenital malformation, a growth retardation <3rd percentile or an abnormal fetal heart rate at randomization are excluded. Women are randomized before 6 cm when oxytocin is either continued or discontinued. Randomization is stratified by center and parity. The primary outcome, neonatal morbidity is assessed using a composite variable defined by an umbilical arterial pH at birth < 7.10 and/or a base excess > 10 mmol/L and/or umbilical arterial lactates> 7 mmol/L and/or a 5 min Apgar score < 7 and/or admission in neonatal intensive care unit. The primary outcome will be compared between the two groups using a chi-square test with a p -value of 0.05. Secondary outcomes include neonatal complications, duration of active phase, mode of delivery, fetal and maternal complications during labor and delivery, including cesarean delivery rate and postpartum hemorrhage, and birth experience. We aim at including 2475 women based on a reduction in neonatal morbidity from 8% in the control group to 5% in the experimental group, with a power of 80% and an alpha risk of 5%. Discussion Discontinuing oxytocin during the active phase of labor could improve both child health, by reducing moderate to severe neonatal morbidity, and maternal health by reducing cesarean delivery and postpartum hemorrhage rates. Trial registration Clinical trials NCT03991091 , registered June 19th, 2019.

Background To evaluate if women with a history of myomectomy have a modified preterm birth risk compared to women with myomas during pregnancy. Methods Retrospective cohort study including all women with a history of myomectomy (operated group) or uterine myomas during pregnancy (unoperated group) who delivered in a tertiary center between January, 2011 and December, 2017. The operated group included women who had a myomectomy history with or without myomas during the ongoing pregnancy. The unoperated group included women with uterine myoma(s) seen on at least one ultrasound during pregnancy without history of myomectomy. The primary outcome was preterm birth < 37 weeks, and the secondary outcome spontaneous preterm birth < 37 weeks. To control for confounding factors, a propensity score approach was used. Two sensitivity analysis were performed, one repeating the analysis using the propensity score after excluding operated women with persistent myomas and one using a classical multivariable logistic regression model. Results The cohort included 576 women: 283 operated women and 293 unoperated women. The rate of preterm birth was similar in the two groups: 12.6% in the unoperated group and 12.0% in the operated group ( p  = 0.82). No difference in preterm birth risk was shown between unoperated and operated women in the cohort matched on the propensity score: OR 0.86; 95%CI [0.47–1.59]. These results were consistent for spontaneous preterm birth (OR 1.61; 95%CI [0.61–4.23]) and for the sensitivity analyses. Conclusion In women with a leiomyomatous uterus, a history of myomectomy is not associated with a reduced preterm birth risk.

Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity. STOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091. Of 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI –2·1 to 2·9); relative risk 1·0 (95% CI 0·8 to 1·4). There were no clinically significant differences in adverse events between the two groups of the safety population. Among participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin. French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique–Hôpitaux de Paris.

(1) Background: triple-negative breast cancer (TNBC) remains a clinical and therapeutic challenge primarily affecting young women with poor prognosis. TNBC is currently treated as a single entity but presents a very diverse profile in terms of prognosis and response to treatment. Positron emission tomography/computed tomography (PET/CT) with 18F-fluorodeoxyglucose ([18F]FDG) is gaining importance for the staging of breast cancers. TNBCs often show high [18F]FDG uptake and some studies have suggested a prognostic value for metabolic and volumetric parameters, but no study to our knowledge has examined textural features in TNBC. The objective of this study was to evaluate the association between metabolic, volumetric and textural parameters measured at the initial [18F]FDG PET/CT and disease-free survival (DFS) and overall survival (OS) in patients with nonmetastatic TBNC. (2) Methods: all consecutive nonmetastatic TNBC patients who underwent a [18F]FDG PET/CT examination upon diagnosis between 2012 and 2018 were retrospectively included. The metabolic and volumetric parameters (SUVmax, SUVmean, SUVpeak, MTV, and TLG) and the textural features (entropy, homogeneity, SRE, LRE, LGZE, and HGZE) of the primary tumor were collected. (3) Results: 111 patients were enrolled (median follow-up: 53.6 months). In the univariate analysis, high TLG, MTV and entropy values of the primary tumor were associated with lower DFS (p = 0.008, p = 0.006 and p = 0.025, respectively) and lower OS (p = 0.002, p = 0.001 and p = 0.046, respectively). The discriminating thresholds for two-year DFS were calculated as 7.5 for MTV, 55.8 for TLG and 2.6 for entropy. The discriminating thresholds for two-year OS were calculated as 9.3 for MTV, 57.4 for TLG and 2.67 for entropy. In the multivariate analysis, lymph node involvement in PET/CT was associated with lower DFS (p = 0.036), and the high MTV of the primary tumor was correlated with lower OS (p = 0.014). (4) Conclusions: textural features associated with metabolic and volumetric parameters of baseline [18F]FDG PET/CT have a prognostic value for identifying high-relapse-risk groups in early TNBC patients.

The European Commission requested EFSA to assess, in collaboration with EMA, the specific concentrations of antimicrobials resulting from cross‐contamination in non‐target feed for food‐producing animals below which there would not be an effect on the emergence of, and/or selection for, resistance in microbial agents relevant for human and animal health, as well as the levels of the antimicrobials which could have a growth promotion/increase yield effect. The assessment was performed for 24 antimicrobial active substances, as specified in the mandate. This scientific opinion describes the methodology used, and the main associated data gaps and uncertainties. To estimate the antimicrobial levels in the non‐target feed that would not result in emergence of, and/or selection for, resistance, a model was developed. This ‘Feed Antimicrobial Resistance Selection Concentration’ (FARSC) model is based on the minimal selective concentration (MSC), or the predicted MSC (PMSC) if MSC for the most susceptible bacterial species is unavailable, the fraction of antimicrobial dose available for exposure to microorganisms in the large intestine or rumen (considering pharmacokinetic parameters), the daily faecal output or rumen volume and the daily feed intake. Currently, lack of data prevents the establishment of PMSC and/or FARSC for several antimicrobials and animal species. To address growth promotion, data from an extensive literature search were used. Specific assessments of the different substances grouped by antimicrobial classes are addressed in separate scientific opinions. General conclusions and recommendations were made.

The specific concentrations of trimethoprim in non‐target feed for food‐producing animals below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. The FARSC for trimethoprim was estimated. Uncertainties and data gaps associated to the levels reported were addressed. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. No suitable data for the assessment were available. It was recommended to perform further studies to supply more diverse and complete data related to the requirements for calculation of the FARSC for trimethoprim.