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"Subtil, Damien"
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Epidemiology of congenital heart defects in France from 2013 to 2022 using the PMSI-MCO (French Medical Information System Program in Medicine, Surgery, and Obstetrics) database
by
Bourdon, Gurvan
,
Subtil, Damien
,
Godart, François
in
Analysis
,
Biology and Life Sciences
,
Cephalosporins
2024
Congenital heart defects are common and occur in approximately 0.9% of births. In France, the registries cover approximately 20% of the population but not the entirety of France; therefore, we aimed to update the incidence data for congenital heart defects in France from 2013 to 2022 using the medico-administrative database PMSI-MCO (French Medical Information System Program in Medicine, Surgery, and Obstetrics). We aimed to compare the frequency of risk factors in a population with congenital heart defects and a reference population.
From 2013 to 2022, we included children aged < 3 years diagnosed with congenital heart defects according to the International Classification of Diseases, 10th Revision, in the PMSI-MCO database. We compared them with a population without congenital defects on several medical data items (e.g., parity, gemellarity, and mortality rate). Bivariate and multivariate analyses compared children with congenital heart defects and children without congenital malformation.
We identified 83,879 children with congenital heart defects in France from 2013 to 2022 in the PMSI-MCO database and 7,739,840 children without such defects, including 7,218,952 without any congenital defects. We observed more deaths (7.49% vs. 0.68%, d = 0.59) and more twinning (8.67% vs. 1.23%, d = 0.35) among children with congenital heart defects. Multivariate analysis revealed an increased risk of congenital heart defects in male individuals (OR [odds ratio] 1.056, 95% CI [confidence interval] [1.039-1.076]) and cases of medically assisted reproduction (OR 1.115, 95% CI [1.045-1.189]) and a reduced risk in the case of multiparity (OR 0.921, 95% CI [0.905-0.938]).
According to the PMSI-MCO database, the incidence of congenital heart defects in France from 2013 to 2022 is 1% of births. Congenital heart defects are more frequent in cases of prematurity, twinning, primiparity, male sex, and maternal age > 40 years.
Journal Article
Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial
2015
Macrosomic fetuses are at increased risk of shoulder dystocia. We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia.
We did this pragmatic, randomised controlled trial between Oct 1, 2002, and Jan 1, 2009, in 19 tertiary-care centres in France, Switzerland, and Belgium. Women with singleton fetuses whose estimated weight exceeded the 95th percentile, were randomly assigned (1:1), via computer-generated permuted-block randomisation (block size of four to eight) to receive induction of labour within 3 days between 37+0 weeks and 38+6 weeks of gestation, or expectant management. Randomisation was stratified by centre. Participants and caregivers were not masked to group assignment. Our primary outcome was a composite of clinically significant shoulder dystocia, fracture of the clavicle, brachial plexus injury, intracranial haemorrhage, or death. We did analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00190320.
We randomly assigned 409 women to the induction group and 413 women to the expectant management group, of whom 407 women and 411 women, respectively, were included in the final analysis. Mean birthweight was 3831 g (SD 324) in the induction group and 4118 g (392) in the expectant group. Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant management (n=25; relative risk [RR] 0·32, 95% CI 0·15–0·71; p=0·004). We recorded no brachial plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group (RR 1·14, 95% CI 1·01–1·29). Caesarean delivery and neonatal morbidity did not differ significantly between the groups.
Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management. Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery. These benefits should be balanced with the effects of early-term induction of labour.
Assistance Publique–Hôpitaux de Paris and the University of Geneva.
Journal Article
Is vaginal delivery of a fetus in breech presentation at an extremely preterm gestational age associated with an increased risk of neonatal death? A comparative study
by
Pierache, Adeline
,
Garabedian, Charles
,
Subtil, Damien
in
Adult
,
Birth weight
,
Breech presentation
2021
The effect on neonatal mortality of mode of delivery of a fetus in breech presentation at an extremely preterm gestational age remains controversial.
To compare mortality associated with planned vaginal delivery (PVD) of fetuses in breech presentation with that of fetuses in breech presentation with a planned cesarean delivery (PCD).
Retrospective study reviewing records over a 19-year period in a level 3 university referral center of singleton infants born between 25+0 and 27+6 weeks of gestation, alive on arrival in the delivery room, and weighing at least 500 grams at birth. Infants in the first group were in breech presentation with PVD and the second in breech presentation with PCD. The principal endpoint was neonatal death.
During the study period, we observed 113 breech presentations with PVD, and 80 breech presentations with PCD. Although not significant after adjustment, neonatal mortality in the breech PVD group was more than twice that of the breech PCD group (19.5 vs 7.8%, P = 0.031, ORa = 2.6, 95% CI 0.8-9.3, NNT = 8). This higher neonatal mortality in the breech PVD group was exclusively associated with a higher risk of death in the delivery room (12.4 vs 0.0% P = 0.001, OR not calculable, NNT = 8). In these extremely preterm breech presentations with PVD, neonatal mortality in the delivery room was associated with entrapment of the aftercoming head, cord prolapse, and a short duration of labor.
For deliveries between 25+0 and 27+6 weeks' gestation, vaginal delivery in breech presentation is associated with a higher risk of death in the delivery room.
Journal Article
Home visiting intervention over pregnancy and the first two years of life to promote healthy feeding practices and energy balance-related behaviors and prevent obesity risk in children from socially disadvantaged families: protocol for a participant-blinded, two-arm, parallel-group randomized controlled trial—the ECAIL study
by
Le Gal, Camille
,
Béghin, Laurent
,
de Lauzon-Guillain, Blandine
in
At risk populations
,
Behavior
,
Biostatistics
2025
Background
Social inequalities in health emerge early in life. The French Malin program, a multi-behavioral and multilevel intervention targeting both individual and structural factors, was co-created by participatory approaches involving diverse stakeholders. These stakeholders include end-users, the French Red Cross, non-profit associations, and two French pediatric societies. The program aims to promote healthy feeding practices (such as breastfeeding) and foster optimal lifestyle behaviors to prevent obesity among children from socially disadvantaged families. The ECAIL study aims to evaluate its effectiveness.
Methods
ECAIL is an ongoing single-blind, two-arm, parallel-group randomized controlled trial, with balanced (1:1) randomization at the individual level. Co-designed with the stakeholders of the Malin program, the trial has been implemented since 2017 in Northern France. Pregnant women are screened for social disadvantages at the main hospital maternity wards in Lille and Valenciennes with the assistance of healthcare providers. Eligible participants are then enrolled for follow-up by trained dietitians, who provide home visits until the child’s second birthday. Participants in the intervention arm receive the two components of the Malin program: (1) personalized support, including the promotion of breastfeeding, advice, and practical tips for a balanced diet and active lifestyle and (2) incentives to access kitchen utensils and healthy foods at reduced prices. Participants in the control arm receive usual care. Primary and secondary outcomes include rate and duration of breastfeeding and complementary feeding practices, dietary intake and lifestyle patterns in children at age 1 and 2 years, and the risk of obesity at age 2. Quantitative data are primarily collected with face-to-face questionnaires and anthropometric measurements. Additionally, semi-structured interviews with study participants and stakeholders will contribute to the process evaluation of this complex intervention.
Discussion
The co-creation of ECAIL, utilizing a bottom-up approach with key stakeholders of the existing Malin program, is a meaningful step toward integrating experiential and academic knowledge. By leveraging mixed data, the findings from this action-research are expected to provide critical insights into the intervention: what it entailed, how it worked, for whom, and to what extent. Amid rising food insecurity, this knowledge will be pivotal in refining the Malin program as it scales up.
Trial registration
ClinicalTrials.gov: NCT03003117.
Journal Article
Is vaginal delivery of a fetus in breech presentation at an extremely preterm gestational age associated with an increased risk of neonatal death? A comparative study
2021
Background The effect on neonatal mortality of mode of delivery of a fetus in breech presentation at an extremely preterm gestational age remains controversial. Objective To compare mortality associated with planned vaginal delivery (PVD) of fetuses in breech presentation with that of fetuses in breech presentation with a planned cesarean delivery (PCD). Material and methods Retrospective study reviewing records over a 19-year period in a level 3 university referral center of singleton infants born between 25+0 and 27+6 weeks of gestation, alive on arrival in the delivery room, and weighing at least 500 grams at birth. Infants in the first group were in breech presentation with PVD and the second in breech presentation with PCD. The principal endpoint was neonatal death. Results During the study period, we observed 113 breech presentations with PVD, and 80 breech presentations with PCD. Although not significant after adjustment, neonatal mortality in the breech PVD group was more than twice that of the breech PCD group (19.5 vs 7.8%, P = 0.031, ORa = 2.6, 95% CI 0.8–9.3, NNT = 8). This higher neonatal mortality in the breech PVD group was exclusively associated with a higher risk of death in the delivery room (12.4 vs 0.0% P = 0.001, OR not calculable, NNT = 8). In these extremely preterm breech presentations with PVD, neonatal mortality in the delivery room was associated with entrapment of the aftercoming head, cord prolapse, and a short duration of labor. Conclusion For deliveries between 25+0 and 27+6 weeks’ gestation, vaginal delivery in breech presentation is associated with a higher risk of death in the delivery room.
Journal Article
Determinants of pregnant women’s knowledge about influenza and the influenza vaccine: A large, single-centre cohort study
by
Carpentier, Sophie
,
Subtil, Damien
,
Mancel, Ophélie
in
Adult
,
Babies
,
Biology and Life Sciences
2020
Although influenza can lead to adverse outcomes during pregnancy, the level of influenza vaccine coverage among pregnant women remains very low. According to the literature, a high level of knowledge about influenza disease and the influenza vaccine is one of the main determinants of vaccination coverage. The objective of the present study was to describe pregnant women's level of knowledge of these topics and to identify any corresponding determinants.
A prospective, observational, hospital-based study of women having given birth in our university medical centre during the 2014-2015 influenza season. Data were collected through a self-questionnaire or extracted from medical records. Determinants of highest knowledge were identified using logistic regression.
Of the 2069 women included in the study, 827 (40%) did not know that influenza can lead to severe adverse outcomes for the mother, and 960 (46%) did not know about possible severe adverse outcomes for the baby. Two hundred and one women (9.8%) stated that the vaccine was \"contraindicated\" or \"unnecessary\" during pregnancy. Only 205 women (17%) had been vaccinated during a previous pregnancy. Determinants of the highest level of knowledge were age over 24, a high educational level, previous influenza vaccination, nulliparity, and the recommendation of vaccination by a healthcare professional.
Recommending vaccination during pregnancy appears to increase knowledge about influenza and its vaccine among pregnant women.
Journal Article
Should pregnant women with anticoagulant prophylaxis benefit from scheduled delivery?
by
Ghesquiere, Louise
,
Subtil Damien
,
Garabedian, Charles
in
Anticoagulants
,
Disease prevention
,
Epidural
2021
PurposeWhen vaginal delivery is considered in women with low-molecular-weight heparin (LMWH) treatment, epidural analgesia is contraindicated for 12–24 h after the last injection. We evaluated the proportion of epidural analgesia depending on whether this is scheduled delivery (labor induction after stopping LMWH) or unscheduled delivery (stopping LMWH at labor onset).MethodsRetrospective hospital study running from 2015 to 2017. Inclusion criteria for patients with LMWH treatment were: singleton pregnancy, gestational age ≥ 38 weeks of gestation and possible vaginal delivery. The primary endpoint was the epidural analgesia rate. Secondary endpoints included risks for caesarean section, deep vein thrombosis, and postpartum hemorrhage.ResultsAmong 129 patients, 54 had scheduled delivery (41.9%). In practice, only 44 of them had labor induction (81.5%) and 54 of the 75 patients in the unscheduled delivery group had spontaneous delivery (72.0%). There was no significant difference in the rate of epidural analgesia between the \"scheduled\" and \"unscheduled\" groups (52/54 (96.3%) vs. 66/75 (88.0%) (p = 0.12)), and no difference in the secondary endpoints.ConclusionHigh access rates to epidural analgesia are observed in both scheduled and unscheduled deliveries. Scheduled delivery does not appear to be a really advantageous strategy for women with LMWH prophylaxis.
Journal Article
Determinants of influenza vaccination uptake in pregnancy: a large single-Centre cohort study
by
Roumilhac, Marielle
,
Vanderstichele, Sophie
,
Dufour, Philippe
in
Babies
,
Behaviours
,
Cohort analysis
2019
Background
Although vaccination of pregnant women against influenza is recommended, the vaccination rate remains low. We conducted a study to identify determinants of influenza vaccination uptake in pregnancy in order to identify strategies to improve seasonal influenza vaccination rates.
Methods
Prospective observational hospital-based study in the French hospital performing the highest number of deliveries, located in the city of Lille, among all women who had given birth during the 2014–2015 influenza season. Data were collected through a self-completed questionnaire and from medical files. The vaccination uptake was self-reported. Determinants of vaccination uptake were identified using logistic regression analysis.
Results
Of the 2045 women included in the study, 35.5% reported that they had been vaccinated against influenza during their pregnancy. The principal factors significantly associated with greater vaccination uptake were previous influenza vaccination (50.9% vs 20.2%, OR 4.1, 95% CI 3.1–5.5), nulliparity (41.0% vs 31.3%, OR 2.5, 95% CI 1.7–3.7), history of preterm delivery < 34 weeks (43.4% vs 30.3%, OR 2.3, 95% CI 1.1–4.9), the mother’s perception that the frequency of vaccine complications for babies is very low (54.6% vs 20.6%, OR 1.1, 95% CI 0.5–2.2), the mother’s good knowledge of influenza and its vaccine (61.7% vs 24.4%, OR 3.1, 95% CI 2.2–4.4), hospital-based prenatal care in their first trimester of pregnancy (55.0% vs 30.2%, OR 2.1, 95% CI 1.2–3.7), vaccination recommendations during pregnancy by a healthcare worker (47.0% vs 2.7%, OR 18.8, 95% CI 10.0–35.8), receipt of a vaccine reimbursement form (52.4% vs 18.6%, OR 2.0, 95% CI 1.5–2.7), and information from at least one healthcare worker about the vaccine (43.8% vs 19.1%, OR 1.8, 95% CI 1.3–2.6).
Conclusions
Our findings suggest that in order to increase flu vaccination compliance among pregnant women, future public health programmes must ensure cost-free access to vaccination, and incorporate education about the risks of influenza and the efficacy/safety of vaccination and clear recommendations from healthcare professionals into routine antenatal care.
Journal Article
Differential Expression of Vegfr-2 and Its Soluble Form in Preeclampsia
2012
Several studies have suggested that the main features of preeclampsia (PE) are consequences of endothelial dysfunction related to excess circulating anti-angiogenic factors, most notably, soluble sVEGFR-1 (also known as sFlt-1) and soluble endoglin (sEng), as well as to decreased PlGF. Recently, soluble VEGF type 2 receptor (sVEGFR-2) has emerged as a crucial regulator of lymphangiogenesis. To date, however, there is a paucity of information on the changes of VEGFR-2 that occur during the clinical onset of PE. Therefore, the aim of our study was to characterize the plasma levels of VEGFR-2 in PE patients and to perform VEGFR-2 immunolocalization in placenta.
By ELISA, we observed that the VEGFR-2 plasma levels were reduced during PE compared with normal gestational age matched pregnancies, whereas the VEGFR-1 and Eng plasma levels were increased. The dramatic drop in the VEGFR-1 levels shortly after delivery confirmed its placental origin. In contrast, the plasma levels of Eng and VEGFR-2 decreased only moderately during the early postpartum period. An RT-PCR analysis showed that the relative levels of VEGFR-1, sVEGFR-1 and Eng mRNA were increased in the placentas of women with severe PE. The relative levels of VEGFR-2 mRNA as well as expressing cells, were similar in both groups. We also made the novel finding that a recently described alternatively spliced VEGFR-2 mRNA variant was present at lower relative levels in the preeclamptic placentas.
Our results indicate that the plasma levels of anti-angiogenic factors, particularly VEGFR-1 and VEGFR-2, behave in different ways after delivery. The rapid decrease in plasma VEGFR-1 levels appears to be a consequence of the delivery of the placenta. The persistent circulating levels of VEGFR-2 suggest a maternal endothelial origin of this peptide. The decreased VEGFR-2 plasma levels in preeclamptic women may serve as a marker of endothelial dysfunction.
Journal Article
Systematic use of carbetocin during cesarean delivery of multiple pregnancies: a before-and-after study
by
Damien, Subtil
,
Elodie, Clouqueur
,
Anne, D’Haveloose
in
Adult
,
Cesarean section
,
Cesarean Section - adverse effects
2013
Purpose
Cesarean deliveries of multiple pregnancies are associated with a high risk of hemorrhage. The aim of this study is to evaluate the efficacy of carbetocin administered systematically during cesarean deliveries of multiple pregnancies.
Methods
Single-center retrospective before-and-after study comparing the use of carbetocin to that of oxytocin during cesareans during two consecutive 6-month periods. A composite variable was predefined as the principal endpoint: any one or more of bleeding ≥1,500 mL, transfusion, hemoglobin reduction of 4 g/dL or more or operative intervention (surgery, embolization).
Results
In an intention-to-treat analysis, the comparison of the two groups (
n
= 24 before and
n
= 39 after) showed no difference for the occurrence of the composite variable (16.7 vs. 15.4 %,
p
= 0.89). Nor did the per-protocol analysis (
n
= 24 before and
n
= 27 after) differ for it (16.7 vs. 14.8 %,
p
= 0.86). Moreover, none of the secondary outcome measures studied—moderate blood loss, prescription of sulprostone, cell-saver use, and intravenous iron infusion—differed significantly between the two periods.
Conclusion
In our population of multiple pregnancies delivered by cesarean, carbetocin did not appear more effective than oxytocin in preventing severe postpartum hemorrhage.
Journal Article