Value of Biochemical Amniotic Fluid Analysis and Fetal Magnetic Resonance Imaging in the Prenatal Diagnosis of Congenital Microgastria.

INTRODUCTION: Congenital microgastria (CM) is a rare condition due to early interruption of stomach development between the 4th and 8th week of gestation, leading to a small midline tubular stomach. Prenatal diagnosis of CM is a challenge with important implications. This study explores the value of biochemical amniotic fluid (AF) analysis and fetal magnetic resonance imaging (MRI) for the prenatal diagnosis of CM in case of nonvisible stomach on fetal ultrasound. CASE PRESENTATION: Four cases of CM were retrospectively investigated in terms of fetal ultrasound, MRI findings, and biochemical AF analyses. The patients were referred to the Prenatal Diagnosis Unit of the Hôpital Femme Mère Enfant (Lyon, France) at a mean age of 21 weeks of gestation for absent or small fetal stomach on ultrasound with a suspected diagnosis of esophageal atresia (EA). Ultrasound examination confirmed that the stomach was absent in two of the four fetuses and small in the other two. This feature was associated with a congenital heart defect in two cases and a terminal transverse limb defect in one case. Standard genetic workup (array-CGH) results were normal. Biochemical AF analysis, including the EA index, was not suggestive of EA. Fetal MRI showed a small midline tubular stomach, associated with a dilated esophagus, highly suggestive of CM. CONCLUSION: If the fetal stomach is absent on ultrasound, CM should be considered if the AF volume is normal, especially during the third trimester, and if the EA index is not suggestive of gastrointestinal obstruction. In these cases, the diagnosis can be confirmed by fetal MRI, through observation of a small midline tubular stomach associated with a dilated esophagus.

Disrespect during childbirth and postpartum mental health: a French cohort study.

BACKGROUND: While the World Health Organisation (WHO) warned about mistreatment, disrespect and/or abuse during childbirth as early as 2014. This same year a social media movement with #payetonuterus brought to light the problematic of obstetrical violence in French speaking countries, and more specifically on issues of disrespect. The experience of care is an integral part of the quality of care, and perception on inadequate support during labour and loss of control in labour are some of the most frequently reported risk factors for childbirth-related post-traumatic stress disorder (CB-PTSD). Therefore, it seems crucial to study the associations between disrespect during childbirth and the mental well-being of mothers. METHODS: We performed a multicentered cohort study using auto-questionnaires within a French perinatal network. The main outcome was women's report of disrespect during childbirth measured by the Behavior of the Mother's Caregivers - Satisfaction Questionnaire (BMC-SQ) 3 days and 2 months after childbirth. CB-PTSD and Postpartum Depression (PPD) were assessed 2 months after childbirth using respectively the Post-Traumatic Checklist Scale (PCLS) and the Edinburgh Postnatal Depression Scale (EPDS). RESULTS: This study followed 123 mothers from childbirth to 2 months postpartum. Among them, 8.13% (n = 10/123) reported disrespect during childbirth at 3 days after childbirth. With retrospect, 10.56% (n = 13/123) reported disrespect during childbirth at 2 months postpartum, i.e. an increase of 31%. Some 10.56% (n = 13/123) of mothers suffered from postpartum depression, and 4.06% (n = 5/123) were considered to have CB-PTSD at 2 months after childbirth. Reported disrespect during childbirth 3 days after birth was significantly associated with higher CB-PTSD 2 months after birth (R2 = 0.11, F(1,117) = 15.14, p < 0.001 and ß = 9.11, p = 0.006), PPD at 2 months after childbirth was positively associated to reported disrespect in the birth room, 3 days after birth (R2 = 0.04, F(1, 117) = 6.28, p = 0.01 and ß = 3.36, p = 0.096). Meanwhile, PPD and CB-PTSD were significantly associated 2 months after childbirth (R2 = 0.41, F=(1,117) = 82.39, p < 0.01 and ß = 11.41, p < 0.001). CONCLUSIONS: Disrespect during childbirth was associated with poorer mental health during the postpartum period. Given the high prevalence of mental health problems and the increased susceptibility to depression during the postpartum period, these correlational results highlight the importance of gaining a deeper awareness of healthcare professionals about behaviours or attitudes which might be experienced as disrespectful during childbirth.

Conservative management or cesarean hysterectomy for placenta accreta spectrum: the PACCRETA prospective study.

BACKGROUND: Placenta accreta spectrum is a life-threatening condition that has increased dramatically in recent decades along with cesarean rates worldwide. Cesarean hysterectomy is widely practiced in women with placenta accreta spectrum; however, the maternal outcomes after cesarean hysterectomy have not been thoroughly compared with the maternal outcomes after alternative approaches, such as conservative management. OBJECTIVE: This study aimed to compare the severe maternal outcomes between women with placenta accreta spectrum treated with cesarean hysterectomy and those treated with conservative management (leaving the placenta in situ). STUDY DESIGN: From a source population of 520,114 deliveries in 176 hospitals (PACCRETA study), we designed an observational cohort of women with placenta accreta spectrum who had either a cesarean hysterectomy or a conservative management (the placenta left in situ) during cesarean delivery. Clinicians prospectively identified women meeting the inclusion criteria and included them at delivery. Data collection started only after the women had received information and agreed to participate in the study in the immediate postpartum period. The primary outcome was the transfusion of >4 units of packed red blood cells within 6 months after delivery. Secondary outcomes were other maternal complications within 6 months. We used propensity score weighting to account for potential indication bias. RESULTS: Here, 86 women had conservative management and 62 women had cesarean hysterectomy for placenta accreta spectrum during cesarean delivery. The primary outcome occurred in 14 of 86 women in the conservative management group (16.3%) and 36 of 61 (59.0%) in the cesarean hysterectomy group (risk ratio in propensity score weighted model, 0.29; 95% confidence interval, 0.19-0.45). The rates of hysterectomy, total estimated blood loss exceeding 3000 mL, any blood product transfusion, adjacent organ injury, and nonpostpartum hemorrhage-related severe maternal morbidity were lower with conservative management than with cesarean hysterectomy (all adjusted, P≤.02); but, the rates of arterial embolization, endometritis, and readmission within 6 months of discharge were higher with conservative management than with cesarean hysterectomy. CONCLUSION: Among women with placenta accreta spectrum who underwent cesarean delivery, conservative management was associated with a lower risk of transfusion of >4 units of packed red blood cells within 6 months than cesarean hysterectomy.

Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery.

BACKGROUND: The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage. METHODS: In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag. RESULTS: Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24). CONCLUSIONS: Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).

Women's dissatisfaction with inappropriate behavior by health care workers during childbirth care in France: A survey study.

BACKGROUND: Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. METHODS: This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self-reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self-reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision-making, or deficient consideration of pain). RESULTS: Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94-7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57-12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision-making. CONCLUSIONS: Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions.

Severity of post-partum hemorrhage after vaginal delivery is not predictable from clinical variables available at the time post-partum hemorrhage is diagnosed.

AIM: Identify women at risk of severe post-partum hemorrhage (PPH) by building a prediction model based on clinical variables available at PPH diagnosis. METHODS: We analyzed data on a cohort of 7236 women with PPH after vaginal delivery from 106 maternity units. Severe PPH was defined as the loss of more than 2000 mL of blood, peripartum drop in hemoglobin of 4 g/dL or more, transfusion of at least four packed red blood cells, embolization, hemostasis surgery, transfer to an intensive care unit or death. The Akaike criterion helped selecting the covariates of a multivariate logistic regression model. The performance of the model was studied through building a receiver-operator curve (ROC). The relative utility of the final model was used to determine the importance of the model in decision-making. RESULTS: Among all PPH, the prevalence of severe cases was 18.5%. Several clinical variables were significantly associated with severe PPH (e.g. parity, multiple pregnancy, labor induction, instrumental delivery). The multivariate prediction model was built. The area under the ROC for prediction of severe cases was 0.63 (95% confidence interval, 0.62-0.65). Nevertheless, the sensitivity and specificity of the prediction model were 0.49 and 0.70, respectively, for a threshold at 0.20 (near prevalence). The relative utility was 0.19 for a threshold near prevalence (20%). CONCLUSION: Because of important misclassifications, even the best model we could build with the available clinical data cannot be reasonably recommended for routine use. Every patient with PPH should receive most optimal management. Other types of information, possibly laboratory data, are probably needed.

[Non elective cesarean section: use of a color code to optimize management of obstetric emergencies]. / Césariennes urgentes non programmées: intérêt des codes couleur pour la gestion optimale des urgences obstétricales.

The medical team of the Croix Rousse teaching hospital maternity unit has developed, over the last ten years, a set of procedures designed to respond to various emergency situations necessitating Caesarean section. Using the Lucas classification, we have defined as precisely as possible the degree of urgency of Caesarian sections. We have established specific protocols for the implementation of urgent and very urgent Caesarean section and have chosen a simple means to convey the degree of urgency to all team members, namely a color code system (red, orange and green). We have set time goals from decision to delivery: 15 minutes for the red code and 30 minutes for the orange code. The results seem very positive: The frequency of urgent and very urgent Caesareans has fallen over time, from 6.1 % to 1.6% in 2013. The average time from decision to delivery is 11 minutes for code red Caesareans and 21 minutes for code orange Caesareans. These time goals are now achieved in 95% of cases. Organizational and anesthetic difficulties are the main causes of delays. The indications for red and orange code Caesarians are appropriate more than two times out of three. Perinatal outcomes are generally favorable, code red Caesarians being life-saving in 15% of cases. No increase in maternal complications has been observed. In sum: Each obstetric department should have its own protocols for handling urgent and very urgent Caesarean sections. Continuous monitoring of their implementation, relevance and results should be conducted Management of extreme urgency must be integrated into the management of patients with identified risks (scarred uterus and twin pregnancies for example), and also in structures without medical facilities (birthing centers). Obstetric teams must keep in mind that implementation of these protocols in no way dispenses with close monitoring of labour.

The challenge of adopting a collaborative information system for independent healthcare workers in France: a comprehensive study.

This study aimed to explore the perception of an underutilised collaborative information system through qualitative research, utilizing semi-structured, in-depth interviews with independent midwives and physician. PROSPERO, is a collaborative information system designed to bridge the communication gap between community-based healthcare workers and hospital-based care teams for parturients in Lyon, France. Through 27 semi-structured in-depth interviews with midwives, obstetricians, and general practitioners, we identified key themes related to the system's adoption: implementation challenges, utilisation barriers, interprofessional dynamics, and hidden variables affecting system use. Participants recognised the potential of PROSPERO to improve information sharing and care coordination but expressed concerns about the system's integration into existing workflows, time constraints, and the need for adequate training and technical support. Interprofessional dynamics revealed differing perspectives between hospital and independent practitioners, emphasising the importance of trust-building and professional recognition. Hidden variables, such as hierarchical influences and confidentiality concerns, further complicated the system's adoption. Despite the consensus on the benefits of a collaborative information system, its implementation was hindered by mistrust between healthcare workers (i.e. between independent practitioners and hospital staff). Our findings suggest that fostering trust and addressing the identified barriers are crucial steps towards successful system implementation. The study contributes to understanding the complex interplay of factors influencing the adoption of collaborative healthcare technologies and highlights the need for strategies that support effective interprofessional collaboration and communication.ClinicalTrials ID NCT02593292.

Risk factors for placenta accreta spectrum disorders in women with any prior cesarean and a placenta previa or low lying: a prospective population-based study.

This study aimed to identify the risk factors for placenta accreta spectrum (PAS) in women who had at least one previous cesarean delivery and a placenta previa or low-lying. The PACCRETA prospective population-based study took place in 12 regional perinatal networks from 2013 through 2015. All women with one or more prior cesareans and a placenta previa or low lying were included. Placenta accreta spectrum (PAS) was diagnosed at delivery according to standardized clinical and histological criteria. Of the 520,114 deliveries, 396 fulfilled inclusion criteria; 108 were classified with PAS at delivery. Combining the number of prior cesareans and the placental location yielded a rate ranging from 5% for one prior cesarean combined with a posterior low-lying placenta to 63% for three or more prior cesareans combined with placenta previa. The factors independently associated with PAS disorders were BMI ≥ 30, previous uterine surgery, previous postpartum hemorrhage, a higher number of prior cesareans, and a placenta previa. Finally, in this high-risk population, the rate of PAS disorders varies greatly, not only with the number of prior cesareans but also with the exact placental location and some of the women's individual characteristics. Risk stratification is thus possible in this population.

How do French Obstetrician-Gynaecologists perceive their quality of life? A national survey.

OBJECTIVE: Obstetrics is a constraining specialty due to heavy workloads and repeated stressful situations. French maternity wards are facing many difficulties to recruit, as a consequence of the conversion of a significant number of Obstetrician-Gynecologists (OB-GYNs) to exclusive daily private practice. The aim of this study was to evaluate the quality of life (QOL) of OB-GYNs in order to identify burnout risk factors, develop prevention strategies and therefore ensure patient safety. STUDY DESIGN: A Google forms questionnaire assessing QOL and life/work balance was distributed by e-mail to 1397 members of the National College of French OB-GYNs (CNGOF). This was a declarative multicenter cross-sectional survey. RESULTS: Four hundred sixty-one responses were collected (response rate 30%). A burnout episode was reported by 31.3% of respondents. Main burnout risk factors were limited staff on the on-call schedule (p = 0.008) and low salary (p < 0.001). On-call work was considered to have a negative personal life impact by 57.8% of the sample; 34.1% wanted to stop this practice and 81.3% believed that financial compensation would help reinforce its attractiveness. Medico-legal risks influenced the daily practices of 70% of respondents and 86.8% had been personally affected by media coverage of obstetrical violence. CONCLUSIONS: This report confirms a high burnout rate within a stressful profession, with major impacts from on-call activity, insufficient salary relative to the arduousness of this practice, high exposure to medico-legal actions and media attention. Revising shift duration to a maximum 12 h, better control over global workload, higher salary and renewed social recognition are urgent priorities.

[Monkeypox: Proposals for care in pregnancy]. / Variole du singe : propositions de conduite à tenir chez les femmes enceintes.

Although the 2022 Monkeypox virus epidemic mostly affects males, particularly men having sex with men, transmission to women may also occur. In case of MPXV infection in pregnancy, transmission to the fetus can result in very severe disease. Thus, caregivers should be aware of the measures to be taken according to the available evidence, in case of exposure or in case of symptoms particularly skin rash compatible with this diagnosis in a pregnant woman. Pregnant women should have access to vaccination, vaccinia immunoglobulin or antiviral medications as required.

Combined first trimester screening for trisomy 21: Assessment of excess risk in case of free ß-human chorionic gonadotrophin between 5 and 10 multiples of the median.

OBJECTIVE: The first trimester combined risk of trisomy 21 is obtained by multiplying the risk related to maternal age by the likelihood ratios of nuchal translucency, free beta-human chorionic gonadotrophin (ß-hCG) and placenta associated plasma protein-A. Beyond five multiples of the median (MoM) of ß-hCG, the risk of trisomy 21 is truncated. The objective of the present study was to evaluate the evolution of the first trimester combined risk of trisomy 21 in individuals with first-trimester free-ß-hCG levels between 5 and 10 MoM. METHODS: We conducted a non-interventional cohort study from a 6-year database of combined first-trimester trisomy 21 screening of all individuals who underwent the screening in a French specialized medical analysis center. We included all pregnant individuals who had a serum-free ß-hCG between 5 and 10 MoM. Patients for whom the status of the fetus, with or without trisomy 21, was not identified by the outcome of the pregnancy or by a karyotype result were excluded from the study. The discriminatory capacity of free-ß-hCG above 5 MoM was studied by a receiver operating characteristic curve. We used an orthogonal polynomial regression to represent the evolution of likelihood ratios according to free-ß-hCG in MoM. RESULTS: Among 413 216 combined first-trimester screens of trisomy 21, 2239 (0.5%) screens met the inclusion criteria. In the selected population, 801 (35.8%) were excluded from the study because of missing fetal or neonatal status, and 46 (3.2%) fetuses out of 1438 included were diagnosed with trisomy 21. For free ß-hCG values between 5 and 10 MoM, the area under the curve is 0.56 (0.46-0.65). The scatterplot of the likelihood ratio of ß-hCG showed an increasing parabolic pattern: the likelihood of trisomy 21 increases with the free-ß-hCG threshold. CONCLUSION: To override the truncated risk of trisomy 21 in case of free ß-hCG values between 5 and 10 MoM, the study has allowed us to estimate the adjusted risk of trisomy 21, enabling health professionals to offer appropriate prenatal counseling.

Fibrinogen for the prediction of severe maternal complications in placental abruption with fetal death after 24 weeks of gestation.

OBJECTIVE: To assess the correlation between standard laboratory indicators at admission and severe maternal complications due to placental abruption (PA) with intrauterine fetal death (IUFD) after 24 weeks. METHODS: Retrospective study in three French tertiary referral hospitals. Correlation of laboratory indicators at admission (platelet count, prothrombin, activated partial thromboplastin time, fibrinogen) and severe maternal complications (massive transfusion, multiple organ failure, hysterectomy, or maternal deaths) in patients with PA and IUFD. RESULTS: Over 12 years, we identified 27/344 (7.8%) pregnant women presenting PA with IUFD. No patient had coagulopathy at admission. Fifteen individuals (55.5%) underwent delivery by cesarean section before or during labor. Fifteen individuals (55.5%) presented severe complications, and 17/27 (63%) lost more than 1 L of blood during delivery. Fibrinogen level was shown to be the laboratory indicator most correlated with severe complications (r = -0.52, P = 0.01). The receiver operating characteristic curve of fibrinogen less than 1.9 g/L in the prediction of severe complications (area under the curve = 0.80, 95% confidence interval [CI] 0.54-0.97) showed both a sensitivity and specificity of 83% (95% CI 54%-96%). CONCLUSIONS: In cases of IUFD with PA, fibrinogen levels at admission had a prognostic value for the prediction of severe maternal complications.

Assessment of uterine artery and aortic isthmus Doppler recordings as predictors of necrotizing enterocolitis.

OBJECTIVE: The purpose of this study was to evaluate whether changes of uterine arteries and aortic isthmus Doppler blood flow recordings could enhance the prediction of necrotizing enterocolitis. STUDY DESIGN: Doppler characteristics of the uterine artery, umbilical and middle cerebral arteries, ductus venosus, and aortic isthmus were reviewed in 123 growth-restricted fetuses who were then divided into 2 groups: with and without necrotizing enterocolitis. RESULTS: Twelve of 123 newborn infants (9%) expressed necrotizing enterocolitis. This group showed significant association between necrotizing enterocolitis and bilateral notching on the uterine artery (83.3% vs 29.7%; P < .001), uterine artery mean resistance index (83.3% vs 36.9%; P < .002), aortic isthmus diastolic blood flow velocity integrals (Z score: -7.32 vs -3.99; P = .028), and absent or negative "a" wave on the ductus venosus (17% vs 1.8%; P = .021). With the use of logistic regression, uterine bilateral notching could predict necrotizing enterocolitis with a sensitivity of 83.3% and a specificity of 70.3%. CONCLUSION: More than any other variable, uterine bilateral notching should be recognized as a strong risk factor for necrotizing enterocolitis.

Live birth rate after cervicoisthmic cerclage in patients with previous late miscarriage and/or premature delivery.

OBJECTIVE: This study assesses the effectiveness of cervicoisthmic cerclage on the live birth rate, measured before and after performing this cerclage in a series of 62 patients with a history of late miscarriage and/or premature delivery. STUDY DESIGN: All patients who underwent cervicoisthmic cerclage in one of the 3 university hospitals of the Hospices Civils de Lyon, between January 1, 2010, and April 1, 2019, and with a history of at least one late miscarriage or spontaneous premature birth, were included. Obstetrical and neonatal data for all pregnancies before and after cervicoisthmic cerclage were collected from medical records, completed by a phone call to patients in case of missing data. RESULTS: We included 62 patients with a total of 224 pregnancies before and 95 pregnancies after cervicoisthmic cerclage. Forty-one (66%) cerclages were performed vaginally, 12 (19%) by laparotomy and 9 (15%) by laparoscopy. The live birth rate among all pregnancies evolving beyond 14 weeks was 23% before and 86% after cerclage (p < 0.01). The rate of delivery beyond 32 weeks was 13% before and 81% after cerclage, with a median term of delivery of 21 weeks and 37 weeks respectively. Twenty-two (35%) patients had at least one live birth before cerclage and 43 (69%) patients after cerclage. Five (8%) postoperative complications occurred (2 grade I, 2 grade II and 1 grade III). CONCLUSION: The markedly high live birth rate when compared to before the cerclage strongly suggests a major role for the technique of cervicoisthmic cerclage in patients with a heavy obstetrical history.

Auricular Acupuncture for Preoperative Anxiety in Parturient Women with Scheduled Cesarean Section: A Randomized Placebo-Controlled Blind Study.

Introduction: Preoperative anxiety before cesarean section is a major issue. Nonpharmacologic anxiety control is believed to be more suitable in pregnant women. Auricular acupuncture (AA) is an inexpensive, easy-to-use, and validated intervention to reduce anxiety in different surgical settings. We evaluated the effect of AA on preoperative cesarean section anxiety. Methods: In a prospective, blind, controlled trial, pregnant women with a scheduled cesarean section under spinal anesthesia were randomized to receive AA with needle, AA without needle (sham), or usual care (no intervention). Anxiety level was assessed by using a visual analogue scale for anxiety (VAS-A; 0-minimal anxiety, 100-maximal anxiety) at three time points: inclusion (pre-induction room-T0), when entering the operating room (T1), and before incision (T2). The primary outcome was the VAS-A variation (percentage changes) between T0 and T1 in the AAe group compared with that in the sham AA group. The secondary outcomes were the VAS-A variation between T0 and T1 in the AA group compared with that in the control group, and the variation between T0 and T2 compared between the three groups, the effect of AA on parasympathetic tone, and the incidence of adverse effects. Results: In women immediately before anesthesia for cesarean section, the AA produced a 19% decrease of anxiety, compared with a 21% anxiety increase in sham AA, which is significantly different. The effect of AA was more present in women with low initial anxiety. The proportion of patients reaching clinically significant anxiety reduction (>33% from the initial level) was 2.5 times higher in the AA group (p = 0.02) compared with the sham group. No differences in anxiety variations were found compared with the no-intervention group. No effect of AA was noted on parasympathetic tone. Conclusion: Compared with sham, AA decreased maternal anxiety level when arriving in the operation room and just before the beginning of the cesarean section, with a trend toward improvement compared with usual care.

Virological and clinical features of acute respiratory failure associated with COVID-19 in pregnancy: a case-control study.

Objective: Pregnancy is a risk factor for acute respiratory failure (ARF) following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We hypothesised that SARS-CoV-2 viral load in the respiratory tract might be higher in pregnant intensive care unit (ICU) patients with ARF than in non-pregnant ICU patients with ARF as a consequence of immunological adaptation during pregnancy. Design: Single-centre, retrospective observational case-control study. Setting: Adult level 3 ICU in a French university hospital. Participants: Eligible participants were adults with ARF associated with coronavirus disease 2019 (COVID-19) pneumonia. Main outcome measure: The primary endpoint of the study was viral load in pregnant and non-pregnant patients. Results: 251 patients were included in the study, including 17 pregnant patients. Median gestational age at ICU admission amounted to 28 + 3/7 weeks (interquartile range [IQR], 26 + 1/7 to 31 + 5/7 weeks). Twelve patients (71%) had an emergency caesarean delivery due to maternal respiratory failure. Pregnancy was independently associated with higher viral load (-4.6 ± 1.9 cycle threshold; P < 0.05). No clustering or over-represented mutations were noted regarding SARS-CoV-2 sequences of pregnant women. Emergency caesarean delivery was independently associated with a modest but significant improvement in arterial oxygenation, amounting to 32 ± 12 mmHg in patients needing invasive mechanical ventilation. ICU mortality was significantly lower in pregnant patients (0 v 35%; P < 0.05). Age, Simplified Acute Physiology Score (SAPS) II score, and acute respiratory distress syndrome were independent risk factors for ICU mortality, while pregnancy status and virological variables were not. Conclusions: Viral load was substantially higher in pregnant ICU patients with COVID-19 and ARF compared with non-pregnant ICU patients with COVID-19 and ARF. Pregnancy was not independently associated with ICU mortality after adjustment for age and disease severity.

Development and validation of nomograms for predicting preterm delivery.

OBJECTIVE: The objective of the study was to develop a statistical model for predicting risk of preterm delivery after in utero transfer for threatened preterm delivery in tertiary care centers. STUDY DESIGN: This study was an observational study including a total of 906 patients transferred for threatened preterm delivery at Paule-de-Viguier and Croix-Rousse University Hospitals. Clinical and sonographic data from 1 series were used to construct logistic regression models for predicting preterm delivery and were validated on an independent series. An Internet-based tool was developed to facilitate the use of the nomograms. RESULTS: Based on multivariate analyses, 2 nomograms were built: 1 to predict delivery within 48 hours after transfer and 1 to predict delivery before 32 weeks. Discrimination and calibration of the predictive models were good when applied to the validation set (concordance index 0.73 and 0.72, respectively). CONCLUSION: We developed and validated nomograms to predict the individual probability of preterm birth after transfer for threatened preterm delivery.

High-dose tranexamic acid reduces blood loss in postpartum haemorrhage.

INTRODUCTION: Our purpose in conducting this study was to determine whether administration of high-dose tranexamic acid (TA) at the time of diagnosis of postpartum haemorrhage (PPH) could reduce blood loss. METHODS: This was a randomised, controlled, multicentred, open-label trial. Women with PPH >800 mL following vaginal delivery were randomly assigned to receive TA (loading dose 4 g over 1 hour, then infusion of 1 g/hour over 6 hours) or not. In both groups, packed red blood cells (PRBCs) and colloids could be used according to French guidelines. The use of additional procoagulant treatments was permitted only in cases involving intractable bleeding. The primary objective was to assess the efficacy of TA in the reduction of blood loss in women with PPH, and the secondary objectives were the effect of TA on PPH duration, anaemia, transfusion and the need for invasive procedures. RESULTS: A total of 144 women fully completed the protocol (72 in each group). Blood loss between enrolment and 6 hours later was significantly lower in the TA group than in the control group (median, 173 mL; first to third quartiles, 59 to 377) than in controls (221 mL; first to third quartiles 105 to 564) (P = 0.041). In the TA group, bleeding duration was shorter and progression to severe PPH and PRBC transfusion was less frequent than in controls (P < 0.03). Invasive procedures were performed in four women in the TA group and in seven controls (P = NS). PPH stopped after only uterotonics and PRBC transfusion in 93% of women in the TA group versus 79% of controls (P = 0.016). Mild, transient adverse manifestations occurred more often in the TA group than in the control group (P = 0.03). CONCLUSIONS: This study is the first to demonstrate that high-dose TA can reduce blood loss and maternal morbidity in women with PPH. Although the study was not adequately powered to address safety issues, the observed side effects were mild and transient. A larger international study is needed to investigate whether TA can decrease the need for invasive procedures and reduce maternal morbidity in women with PPH. TRIAL REGISTRATION: Controlled Trials ISRCTN09968140.