Around one third of boys with severe hemophilia A develop inhibitors (neutralizing antibodies) against their therapeutic factor VIII product. This adverse effect may result in more life-threatening ...bleeding, disability, impaired quality of life, and costly care. We compared the incidence of inhibitors in boys treated with the three factor VIII products most used in France: one plasma-derived (Factane) and two recombinant products (Advate and Kogenate Bayer). A previously untreated cohort of patients was created in 1994 to investigate risk factors for inhibitor development. We selected boys with severe hemophilia A (factor VIII <1 IU/dL) first treated with one of the three factor VIII products studied. Details of product infusions, inhibitor assays and main fixed and time-varying inhibitor risk factors were recorded for the first 75 exposure days. Three outcomes (all inhibitors, high-titer inhibitors and subsequently treated inhibitors) were analyzed by univariate and multivariate Cox models. We studied 395 boys first treated between 2001 and 2016 (131, 137, and 127 with Factane, Advate, and Kogenate Bayer, respectively). Clinically significant inhibitors were diagnosed in 121 patients (70 high-titer). The incidence of high-titer inhibitors was significantly associated with the factor VIII product received (
=0.005): the cumulative incidence at 75 exposure days was 12.7% (95% CI: 7.7-20.6) with Factane, 20.4% (95% CI: 14.0-29.1) with Advate, and 31.6% (95% CI: 23.5-41.7) with Kogenate Bayer. The low inhibitor incidence observed with Factane is concordant with recent findings from the SIPPET randomized trial. These consistent results from observational and experimental studies should lead to improved care for previously untreated patients and cost savings for healthcare systems worldwide.
During the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic lockdown, communication between pregnant women and health professionals may have become complicated due to ...restrictions on movement and saturated health services. This could have impacts on pregnancy monitoring and women's wellbeing. We aimed to i) describe the unmet need of pregnant women living in France to communicate with health professionals about the pandemic and their pregnancy during the lockdown, ii) assess the socio-demographic, medical and contextual factors associated with this unmet need. The Covimater cross-sectional study, conducted in July 2020, includes data on 500 adult women's experiences of pregnancy during the first lockdown period in France (i.e., from March to May 2020). The women, all residents in metropolitan France, answered a web-based questionnaire about their conversations with health professionals during the lockdown, as well as their social and medical characteristics. A robust variance Poisson regression model was used to estimate crude or adjusted prevalence ratios (aPRs) for their unmet need to communicate with health professionals about the pandemic and their pregnancy. Forty-one percent of participants reported an unmet need to communicate with a health professional during the lockdown, mainly about the risk of transmitting SARS-CoV-2 to their baby and the consequences for the latter. Factors associated were: i) being professionally inactive (aPR = 1.58,CI95%(1.14-2.21), ii) having an educational level below secondary school diploma (1.38,1.05,-1.81), iii) having experienced serious arguments/violence (2.12,1.28-3.52), iv) being very worried about the pandemic (1.41,1.11-1.78), v) being primiparous (1.36,1.06-1.74) and vi) having had pregnancy consultations postponed/cancelled by health professionals during the lockdown (1.35,1.06-1.73). These results can be used to develop targeted strategies that ensure pregnant women are able to i) communicate with health professionals about the potential impact of the SARS-CoV-2 pandemic on their pregnancy, and ii) access up-to-date and reliable information on the consequences of SARS-CoV-2 for themselves and their child.
Breastfeeding (BF) initiation rates in French maternity units are among the lowest in Europe. After increasing for several years, they decreased between 2010 and 2016, although several maternal ...characteristics known to be positively associated with BF in France were more frequent. We aimed to (1) quantify adjusted trends in BF initiation rates between 2010 and 2016; (2) examine associations between BF initiation rates and newborn, maternal, maternity unit, and department‐level characteristics. Using data from the 2010 (n = 12,224) and 2016 (n = 11,089) French National Perinatal Surveys, we analysed BF initiation (exclusive, mixed, and any) through a succession of six mixed‐effect multinomial regression models, progressively adding adjustment covariates. Adjusted exclusive and any BF initiation rates decreased by 9.6 and 4.5 points, respectively, versus by 7.7 and 1.8 points, respectively, in the crude analysis. In both years, adjusted exclusive and any BF initiation rates were lowest in the following categories of mothers: low education level, single, high body mass index and multiple or premature births. Exclusive BF initiation decreased most in primiparous mothers, those with the lowest household income, mothers that had a vaginal delivery, women born in an African country and those who delivered in a maternity unit without Baby‐Friendly Hospital Initiative designation. The 2010–2016 decrease in BF initiation rates in France cannot be explained by changes in mothers' characteristics; quite the opposite, adjustment increased its magnitude. Additional efforts should be put in place to understand why this decrease is particularly sharp in some subgroups of mothers.
Differences in predicted exclusive, mixed and any breastfeeding (BF) initiation rates between 2016 and 2010 (i.e., marginal effect of the year) were estimated with six nested models that adjusted for an increasing number of covariates. Any BF initiation rates are equal to the sum of exclusive and mixed BF initiation rates. The six models were built cumulatively including a year index (Model 1), spatial random effect (Model 2), individual characteristics (Model 3), maternity unit characteristics (Model 4), French department characteristics (Model 5), and interaction terms between the year and the covariates (Model 6). Data for metropolitan France from the 2010 and 2016 French National Perinatal Surveys (NPS).
Key points
While some maternal characteristics previously known to be positively associated with breastfeeding (BF) in France were more frequent in 2016 than 2010, any BF initiation rate in maternity units in France decreased by 2 points (from 68.7% to 66.7%), and exclusive BF by 8 points (from 60.3% to 52.2%). Even greater decreases (4.5 and 9.6 points, respectively) were observed after adjusting for the characteristics of mothers, newborns, maternity units, and departments.
Between 2010 and 2016, the largest decreases in adjusted exclusive BF initiation rates were observed in primiparous mothers, those with the lowest household income, mothers that had a vaginal delivery, women born in an African country and those who delivered in a maternity unit without Baby‐Friendly Hospital Initiative designation.
In the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, consultations and pregnancy monitoring examinations had to be reorganised urgently. In addition, women ...themselves may have postponed or cancelled their medical monitoring for organisational reasons, for fear of contracting the disease caused by SARS-CoV-2 (COVID-19) or for other reasons of their own. Delayed care can have deleterious consequences for both the mother and the child. Our objective was therefore to study the impact of the SARS-CoV-2 pandemic and the first lockdown in France on voluntary changes by pregnant women in the medical monitoring of their pregnancy and the associated factors.
A cross-sectional study was conducted in July 2020 using a web-questionnaire completed by 500 adult (> 18 years old) pregnant women during the first French lockdown (March-May 2020). A robust variance Poisson regression model was used to estimate adjusted prevalence ratios (aPRs).
Almost one women of five (23.4%) reported having voluntarily postponed or foregone at least one consultation or pregnancy check-up during the lockdown. Women who were professionally inactive (aPR = 1.98, CI95%1.24-3.16), who had experienced serious disputes or violence during the lockdown (1.47, 1.00-2.16), who felt they received little or no support (1.71, 1.07-2.71), and those who changed health professionals during the lockdown (1.57, 1.04-2.36) were all more likely to have voluntarily changed their pregnancy monitoring. Higher level of worry about the pandemic was associated with a lower probability of voluntarily changing pregnancy monitoring (0.66, 0.46-0.96).
Our results can guide prevention and support policies for pregnant women in the current and future pandemics.
Objectives:
To describe maternal smoking trends in France between 1972 and 2016, and identify whether maternal characteristics associated with smoking in the 3rd trimester of pregnancy evolved ...between 2010 and 2016.
Methods:
Using French National Perinatal Surveys, we estimated proportions of smokers and the number of cigarettes smoked both just before pregnancy and during the 3rd trimester from 1972 to 2016. We used a Poisson model with robust variance to estimate prevalence ratios for smoking during pregnancy.
Results:
Proportions of mothers quitting smoking were relatively stable (46.0% in 1972 and 45.8% in 2016). The number of cigarettes smoked just before pregnancy and in the 3rd trimester decreased from 1995 onward. However, proportions of smokers remained high before (30.1%) and during the 3rd trimester in 2016 (16.2%). Smoking in the 3rd trimester was associated with a lower education level and lower income in both 2010 and 2016, whereas the association with age, country of birth and parity varied according to the survey year.
Conclusion:
Early targeted interventions are needed for smokers who plan to have a child and must take smokers’ characteristics during pregnancy into account.
Abstract Background The Baby-Friendly Hospital Initiative (BFHI) is associated with improved breastfeeding outcomes in many high-income countries including the UK and the USA, but its effectiveness ...has never been evaluated in France. We investigated the impact of the BFHI on breastfeeding rates in French maternity units in 2010, 2016 and 2021 to assess if the BFHI aids to reduce inequalities in breastfeeding. Methods We examined breastfeeding in maternity units (exclusive, mixed and any breastfeeding) in mothers of singleton full-term newborns using the 2010 (n = 13 075), 2016 (n = 10 919) and 2021 (n = 10 209) French National Perinatal Surveys. We used mixed-effect hierarchical multinomial regression models adjusting for neonatal, maternal, maternity unit and French administrative department characteristics, and tested certain interactions. Results The adjusted rate of exclusive breastfeeding was higher by +5.8 (3.4–8.1) points among mothers delivering in BFHI-accredited maternity units compared with those delivering in non-accredited units. When compared with average-weight newborns, this difference was sharper for infants with low birthweight: +14.9 (10.0–19.9) points when their birthweight was 2500 g. Mixed breastfeeding was lower by -1.7 points (-3.2–0) in BFHI-accredited hospitals, with no notable difference according to the neonatal or maternal characteristics. Conclusion Mothers delivering in BFHI-accredited maternity units had higher exclusive breastfeeding rates and lower mixed breastfeeding rates than those delivering in non-accredited maternity units. The positive impact of the BFHI was stronger among low-birthweight neonates, who are less often breastfed, helping reduce the gap for this vulnerable group while favouring mothers with higher education levels.
•First French national estimate of potential FASD using medico administrative data.•Stable rate of potential FASD and increased frequency of FAS between 2006 and 2013.•Regional variability may be ...explained by local mobilization around pFASD diagnosis.•A low range for estimating the burden of prenatal alcohol exposure at birth.•Active surveillance could be initiated considering the public health burden.
At birth, only complete Fetal Alcohol Syndrome (FAS) can be properly diagnosed. However, other Consequences of prenatal Alcohol Exposure (CAE) can also be recorded. Our objective was to describe the frequency of diagnoses highly suggestive of “potential Fetal Alcohol Syndrome Disorder” (pFASD, i.e., FAS and CAE) among hospitalized neonates, during the neonatal period, in France, between 2006 and 2013.
We used the French national hospital discharge database to identify the Q86.0 (FAS) and P04.3 (CAE) ICD-10 codes in hospital stays occurring in the first 28 days of life. FAS, CAE and pFASD rates were estimated per 1000 live births at the national level for the 2009–2013 period. We compared the 2006–2009 and 2010–2013 rates. The pFASD rates were also estimated at the regional level.
Overall, 3,207 cases of pFASD were diagnosed during the neonatal period (i.e., 0.48 cases per 1000 live births, including 0.07 cases of FAS per 1000). Between 2006–2009 and 2010–2013, pFASD remained stable, despite a moderate decrease in reported FAS (0.08 vs 0.06 cases per 1000, p < 0.001). At the regional level, pFASD rates varied between 0.13 and 1.22 cases per 1000.
This study provides the first national estimate of neonatal diagnosis of FAS, and more broadly pFASD, in France. Although our data certainly underestimate the real prevalence of FASD, they provide a minimal estimate of the burden of alcohol use during pregnancy. Observed variations deserve to be analyzed in the light of concomitant prevention and public information campaigns.
Inhibitor development is the major treatment complication in children with severe hemophilia A. It is not clear whether the risk of inhibitors is higher with recombinant factor VIII or with ...plasma-derived factor VIII. We used multivariate analysis to compare 2 cohorts of previously untreated patients (PUPs) with severe hemophilia A: 62 patients treated with the same brand of high-purity plasma-derived FVIII (pFVIII) containing von Willebrand factor (VWF) and 86 patients treated with full-length recombinant FVIII (rFVIII). In addition to the usual end points (all inhibitors, high inhibitors), we also examined a third end point (high inhibitors and/or immune tolerance induction). The risk of inhibitor development was higher in patients treated with rFVIII than in patients treated with pFVIII, regardless of other risk factors (F8 genotype; nonwhite origin; history of inhibitors in patients with a family history of hemophilia; age at first FVIII infusion). The adjusted relative risk (RRa) for inhibitor development with rFVIII versus pFVIII was 2.4 (all inhibitors), 2.6 (high inhibitors), and 3.2 (high inhibitors and/or immune tolerance induction), respectively, depending on the end point (above). The pathophysiology of this large effect must be understood in order to improve the characteristics of recombinant products and to reduce the incidence of inhibitors to FVIII.
To report results of the 2021 French National Perinatal Survey (ENP) in metropolitan France and assess trends in the main indicators of perinatal health, medical practices, and risk factors in France ...since 1995.
All the samples included all women giving birth at a gestational age of at least 22 weeks of gestation and/or to an infant weighing at least 500 grams in all maternity units in metropolitan France during one week in 1995 (N=13 048), 2003 (N=14 324), 2010 (N=14 546), 2016 (N=12 553), and 2021 (N=12 088). The data came from postpartum interviews of the women at the hospital and their medical records. Comparisons between surveys showed trends over time.
Between 1995 and 2021, maternal characteristics changed. Maternal age and the frequency of women with obesity rose: in 2021, 24.6% of women were 35 years or older (21.1% in 2016, 19.2% in 2010, 15.9% in 2003 and 12.4% in 1995) and 14.4% were obese (11.8% in 2016, 9.9% in 2010 and 7.4% in 2003). Some antenatal prevention behaviors that improved in 2021 were not smoking during the third trimester, acid folic administration before pregnancy, and vaccination against influenza. The percentage of women with an early prenatal appointment ("4
month appointment"), implemented to facilitate screening of maternal vulnerability during pregnancy, has continued to rise. The percentage of women receiving prenatal care by midwives has risen markedly (39.0% in 2021 versus 11.7% in 2016). Serum screening for Down syndrome continues to increase (91.8% of women in 2021). The rate of induction of labor has risen significantly (20.2% in 1995 and 25.8% in 2021). The mode of delivery has not varied significantly since 2003; in 2021, the cesarean rate was 21.4% and the instrumental vaginal delivery rate 12.4%. Episiotomy was increasingly rare, among both primiparous and multiparous women (16.5% and 2.9% in 2021, respectively). The prevalence of coronavirus (SARS-CoV2) infection during pregnancy was 5.7%. Preterm live births increased regularly, slightly but significantly over the 1995-2016 period and then remained stable between 2016 and 2021 (7.0%). In 2021, 56.3% of women exclusively breastfed during their hospital stay, a modest increase in comparison with 2016 (54.6%).
Routine national perinatal surveys highlight positive trends over time in some preventive practices, decreases in some medical interventions consistent with national guidelines, and the increasing role of midwives in prenatal care. Nonetheless, some indicators remain less than optimal and require more detailed analyses.
Introduction
Standard treatment of congenital haemophilia A is based on replacement therapy with coagulation factor VIII (FVIII) products. A major complication of FVIII therapy is the occurrence of ...IgG alloantibodies (inhibitors) that neutralize FVIII activity.
Aim
The aim of the analysis was estimating the risk of high‐titre inhibitor associated with the second‐generation full‐length product compared to third‐generation full‐length product and other recombinant FVIII (rFVIII).
Methods
We conducted a combined analysis of individual patient data from three large studies in previously untreated patients (PUPs) with severe haemophilia A.
Results
A total of 1109 PUPs were treated from 1993 to 2013 including 787 PUPs treated from 2004 onwards (primary analysis cohort). A total of 322 patients (29.0%) developed an inhibitor, of which 192 (17.3%) a high‐titre inhibitor. In the primary analysis set, 29.9% of patients developed an inhibitor and 17.2% a high‐titre inhibitor. The combined analysis indicated a lower risk of high‐titre inhibitor development for the third‐generation rFVIII product compared to the second‐generation rFVIII product (primary analysis: adjusted hazard ratio (HR) = 0.72, 95% CI: 0.49 to 1.06). Adjusted HR for all inhibitor development was significantly lower for the third‐generation product compared to the second‐generation product.
Conclusion
The trend of an increased risk of inhibitor development in PUPs for one recombinant product illustrates that extrapolation from one recombinant factor VIII product to other products might not be justified.
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