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.
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.
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).
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 .).
Fetal heart rate (FHR) monitoring is routinely used in clinical practice to help obstetricians assess fetal health status during delivery. However, early detection of fetal acidosis that allows ...relevant decisions for operative delivery remains a challenging task, receiving considerable attention. This contribution promotes sparse support vector machine classification that permits to select a small number of relevant features and to achieve efficient fetal acidosis detection. A comprehensive set of features is used for FHR description, including enhanced and computerized clinical features, frequency domain, and scaling and multifractal features, all computed on a large (1288 subjects) and well-documented database. The individual performance obtained for each feature independently is discussed first. Then, it is shown that the automatic selection of a sparse subset of features achieves satisfactory classification performance (sensitivity 0.73 and specificity 0.75, outperforming clinical practice). The subset of selected features (average depth of decelerations MAD dtrd , baseline level β 0 , and variability H) receives simple interpretation in clinical practice. Intrapartum fetal acidosis detection is improved in several respects: A comprehensive set of features combining clinical, spectral, and scale-free dynamics is used; an original multivariate classification targeting both sparse feature selection and high performance is devised; state-of-the-art performance is obtained on a much larger database than that generally studied with description of common pitfalls in supervised classification performance assessments.
Intrapartum fetal heart rate monitoring, aiming at early acidosis detection, constitutes an important public health stake. Scattering transform is proposed here as a new tool to analyze intrapartum ...fetal heart rate (FHR) variability. It consists of a nonlinear extension of the underlying wavelet transform, that thus preserves its multiscale nature. Applied to an FHR signal database constructed in a French academic hospital, the scattering transform is shown to permit to efficiently measure scaling exponents characterizing the fractal properties of intrapartum FHR temporal dynamics, that relate not only to the sole covariance (correlation scaling exponent), but also to the full dependence structure of data (intermittency scaling exponent). Such exponents are found to satisfactorily discriminate temporal dynamics of healthy subjects (from that of nonhealthy ones) and to emphasize the role of the highest frequencies (around and above 1 Hz) in intrapartum FHR variability. This permits us to achieve satisfactory classification performance that improves on those obtained from the analysis of International Federation of Gynecology and Obstetrics (FIGO) criteria, notably by classifying as healthy a number of subjects that were incorrectly classified as nonhealthy by classical clinically used FIGO criteria. Combined to obstetrician annotations, these scaling exponents enable us to sketch a typology of these FIGO-false positive subjects. Also, they permit us to monitor the evolution along time of the intrapartum health status of the fetuses and to estimate an optimal detection time-frame.
The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis. FHR variability is traditionally investigated using Fourier transform, often with adult predefined ...frequency band powers and the corresponding LF/HF ratio. However, fetal conditions differ from adults and modify spectrum repartition along frequencies.
This study questions the arbitrariness definition and relevance of the frequency band splitting procedure, and thus of the calculation of the underlying LF/HF ratio, as efficient tools for characterizing intrapartum FHR variability.
The last 30 minutes before delivery of the intrapartum FHR were analyzed.
Case-control study. A total of 45 singletons divided into two groups based on umbilical cord arterial pH: the Index group with pH ≤ 7.05 (n = 15) and Control group with pH > 7.05 (n = 30).
Frequency band-based LF/HF ratio and Hurst parameter.
This study shows that the intrapartum FHR is characterized by fractal temporal dynamics and promotes the Hurst parameter as a potential marker of fetal acidosis. This parameter preserves the intuition of a power frequency balance, while avoiding the frequency band splitting procedure and thus the arbitrary choice of a frequency separating bands. The study also shows that extending the frequency range covered by the adult-based bands to higher and lower frequencies permits the Hurst parameter to achieve better performance for identifying fetal acidosis.
The Hurst parameter provides a robust and versatile tool for quantifying FHR variability, yields better acidosis detection performance compared to the LF/HF ratio, and avoids arbitrariness in spectral band splitting and definitions.
IntroductionThis trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by ...first-trimester uterine artery Dopplers as at high risk of preeclampsia.MethodsThis randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death.ResultsThe trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 -2.6; 5.9 p = 0.45). The two groups did not differ significantly for the secondary outcomes.ConclusionLow-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia.Trial registration(NCT0172946).
This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester ...uterine artery Dopplers as at high risk of preeclampsia. This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged greater than or equal to 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index greater than or equal to 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight less than or equal to 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight less than or equal to 5th percentile and perinatal death. The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight less than or equal to 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 -2.6; 5.9 p = 0.45). The two groups did not differ significantly for the secondary outcomes. Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight less than or equal to 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia.
Between 0.5 and 5% of vaginal deliveries involve obstetrical anal sphincter injuries (OASIS). Thirty to forty percent of patients with OASIS will suffer from anal incontinence in the subacute ...postpartum period.
The aim of the present study was to assess the effectiveness of early pelvic floor muscle training (PFMT) combined with standard rehabilitation on anal incontinence after vaginal deliveries complicated by OASIS.
The present work was a retrospective quantitative study performed in a tertiary-level maternity hospital. Women with 3rd or 4th degree obstetric tears were included. Women who gave birth between January 1st, 2011 and December 31st, 2012 underwent standard pelvic-perineal rehabilitation within 6–8 weeks postpartum. Women who gave birth between January 1st, 2013 and July 1st, 2014 had early rehabilitation (within 30 days after delivery) followed by the same standard rehabilitation received by the other group. Rehabilitation was performed by physiotherapists specialized in perineology. No electrostimulation was done in early rehabilitation. An in-house-validated modification of the Jorge and Wexner questionnaire was sent by mail to the patients to assess symptoms. The main judgment criterion was anal incontinence to gas, loose stools and/or solid stool.
Two hundred and thirty patients were diagnosed with OASIS. Nineteen women (8.3%) were lost to follow-up. The intention-to-treat analysis included 211 patients, 109 of whom underwent standard rehabilitation and 102 early rehabilitation plus standard rehabilitation. The two groups were comparable in terms of parity, birth weight, assisted delivery, epidural anesthesia and rates of mediolateral episiotomy. Multivariate analyses adjusted for type of perineal lesion were performed. Early rehabilitation significantly reduced gas leakage: OR 0.51 0.29–0.90 (p=0.02), liquid stool leakage: OR 0.22 0.08–0.58 (p=0.02) and urinary stress incontinence: OR 0.43 0.24–0.77 (p=0.004).
We recommend early (during the first month postpartum) PFMT after vaginal deliveries associated with OASIS. Rehabilitation should be carried out by a physiotherapist specialized in perineology in order to prevent medium-term functional consequences. A longer follow-up may be necessary to confirm the stability of results.
Intrapartum fetal heart rate (FHR) monitoring constitutes a reference tool in clinical practice to assess the baby’s health status and to detect fetal acidosis. It is usually analyzed by visual ...inspection grounded on FIGO criteria. Characterization of intrapartum fetal heart rate temporal dynamics remains a challenging task and continuously receives academic research efforts. Complexity measures, often implemented with tools referred to as approximate entropy (ApEn) or sample entropy (SampEn), have regularly been reported as significant features for intrapartum FHR analysis. We explore how information theory, and especially auto-mutual information (AMI), is connected to ApEn and SampEn and can be used to probe FHR dynamics. Applied to a large (1404 subjects) and documented database of FHR data, collected in a French academic hospital, it is shown that (i) auto-mutual information outperforms ApEn and SampEn for acidosis detection in the first stage of labor and continues to yield the best performance in the second stage; (ii) Shannon entropy increases as labor progresses and is always much larger in the second stage; (iii) babies suffering from fetal acidosis additionally show more structured temporal dynamics than healthy ones and that this progressive structuration can be used for early acidosis detection.
The development of leadership skills has been the topic of several position statements over recent decades, and the need of medical leaders for a specific training was emphasized during the COVID-19 ...crisis, to enable them to adequately collaborate with governments, populations, civic society, organizations, and universities. However, differences persist as to the way such skills are taught, at which step of training, and to whom. From these observations and building on previous experience at the University of Ottawa, a team of medical professors from Lyon (France), Ottawa, and Montreal (Canada) universities decided to develop a specific medical leadership training program dedicated to faculty members taking on leadership responsibilities. This pilot training program was based on a holistic vision of a transformation model for leadership development, the underlying principle of which is that leaders are trained by leaders. All contributors were eminent French and Canadian stakeholders. The model was adapted to French faculty members, following an inner and outer analysis of their specific needs, both contextual and related to their time constraints. This pilot program, which included 10 faculty members from Lyon, was selected to favor interactivity and confidence in older to favor long-term collaborations between them and contribute to institutional changes from the inner; it combined several educational methods mixing interactive plenary sessions and simulation exercises during onescholar year. All the participants completed the program and expressed global satisfaction with it, validating its acceptability by the target. Future work will aim to develop the program, integrate evaluation criteria, and transform it into a graduating training.
Background
Introduction: There is clear evidence that fetuses with intrauterine growth restriction (IUGR) do not receive the minimum evidence-based care during their antenatal management.
Objective
...Considering that optimal management of IUGR may reduce neonatal morbi-mortality in IUGR, the objective of the present study was to evaluate the impact of antenatal management of IUGR according to the recommendations of the French college of gynecologists and obstetricians (CNGOF) on the neonatal prognosis of IUGR fetuses.
Study design
From a historical cohort of 31,052 children, born at the Femme Mère Enfant hospital (Lyon, France) between January 1, 2011 and December 31, 2017, we selected the population of IUGR fetuses. The minimum evidence-based care (MEC) in the antenatal management of fetuses with IUGR was defined according to the CNGOF recommendations and neonatal prognosis of early and late IUGR fetuses were assessed based on the whether or not they received MEC. The neonatal prognosis was defined according to a composite criterion that included neonatal morbidity and mortality.
Results
A total of 1020 fetuses with IUGR were studied. The application of MEC showed an improvement in the neonatal prognosis of early-onset IUGR (
p
= 0.003), and an improvement in the neonatal prognosis of IUGR born before 32 weeks (
p
= 0.030). Multivariate analysis confirmed the results showing an increase in neonatal morbi-mortality in early-onset IUGR in the absence of MEC with OR 1.79 (95% CI 1.01–3.19).
Conclusion
Diagnosed IUGR with MEC had a better neonatal prognosis when born before 32 weeks. Regardless of the birth term, MEC improved the neonatal prognosis of fetuses with early IUGR. Improvement in the rate of MEC during antenatal management has a significant impact on neonatal prognosis.