6 research outputs found
Incidence et facteurs de risque des infections bactériennes néonatales à Streptocoque B (évaluation d'une politique de non dépistage systématique)
Introduction : Les infections bactériennes sont la première cause d hospitalisation des nouveau-nés à terme. La prévention recommandée par l HAS repose sur le dépistage par prélèvement vaginal et l antibioprophylaxie per-partum en cas de portage de streptocoque B. En raison du doute sur le rapport bénéfice/risque de l antibioprophylaxie large, l équipe obstétrico-pédiatrique de l hôpital Louis Mourier avait choisi en 2002 de ne pas les utiliser. Objectif : L objectif principal de cette étude est d évaluer l incidence des infections bactériennes néonatales à streptocoque du groupe B. Les objectifs secondaires sont, d étudier les facteurs de risque d infection bactérienne néonatale précoce dans notre population, la prise en charge des nouveau-nés colonisés, et d étudier les conséquences de cette stratégie sur l écologie bactérienne. Patientes et méthodes : Il s agit d une étude rétrospective monocentrique portant sur toutes les naissances à la maternité de l hôpital Louis Mourier du 1er janvier 2005 au 31 décembre 2007. Le protocole de la maternité ne comportait pas de dépistage systématique. Résultats : Durant les 3 années de l étude, nous avons inclus 6 727 naissances, issues de 6 557 grossesses. L incidence des infections certaines à streptocoque B est de 1.34 pour mille, soit 9 cas. Ainsi 120 enfants ont été hospitalisés pour suspicion d'infection à streptocoque B. Deux tiers de ces nouveau-nés le sont pour une CRP augmentée et sont asymptomatiques. Le taux d antibiothérapie per partum est de 2.9 %. Le taux d Escherichia Coli résistant à l ampicilline est de 30 % soit deux fois moins que dans la littérature. Il n y a pas eu de cas d anaphylaxie. Un seul décès d un enfant polymalformé, infecté a été rapporté. Le recours à la réanimation a été nécessaire chez 0.28% des nouveaux nés. Conclusion : L incidence des infections certaines à SGB, en l absence d antibioprophylaxie per partum est comparable à celle retrouvée dans la littérature avant dépistage. Peu de cas d infections sévères ont été rapportés. Mais, l augmentation du nombre d hospitalisations pour suspicion d infection materno-fœtale nous a incité à modifier notre prise en charge.PARIS13-BU Serge Lebovici (930082101) / SudocSudocFranceF
Fausses couches tardives (étiologie et moyens de prévention à propos d'une série de 90 cas)
PARIS7-Xavier Bichat (751182101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF
Delayed-Interval Delivery of Twins in 13 Pregnancies
International audienceBackground: Delayed interval delivery is a rare practice aiming at prolonging gestation for the second twin in case of pre-viable birth of twin one. Our objective was to identify factors related to successful delayed delivery of the second twin, among cases in which the interval after delivery of the first twin was above 24h.Method: A descriptive, retrospective and multicenter study of all delayed interval deliveries in dichorionic twins in 4 perinatal centers in Paris over a 14-year period.Results: In 13 cases of delayed interval delivery, delivery of twin 1 was at a median of 18 weeks' gestation (range 14WG+2days to 24WG), and none survived. Delivery of the second twin occurred at a median of 25 weeks' gestation +3 days, 51 days after twin 1 (range 13-138 days). Seven of the 13s twins (54 %) survived. There were 5 cases of chorioamnionitis and 1 case of maternal disseminated intravascular coagulation. Poor outcome was not significantly associated with the gestational age, presentation for PPROM or inflammatory markers (C-reactive protein and white blood cell count) at the time of delivery of twin 1.Conclusion: Delayed-interval delivery of the second twin may prolong pregnancy and lead the second twin child to a viable term of birth; but carries a risk of maternal complications
Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone : a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial
Background: Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome.
Methods: We designed a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial in 37 level 3 referral perinatal centres in France. Eligible participants were pregnant women aged 18 years or older with a singleton fetus at risk of preterm delivery and already treated with the first injection of antenatal betamethasone (11·4 mg) before 32 weeks' gestation. We used a computer-generated code producing permuted blocks of varying sizes to randomly assign (1:1) women to receive either a placebo (half-dose group) or a second 11·4 mg betamethasone injection (full-dose group) 24 h later. Randomisation was stratified by gestational age (before or after 28 weeks). Participants, clinicians, and study staff were masked to the treatment allocation. The primary outcome was the need for exogenous intratracheal surfactant within 48 h after birth. Non-inferiority would be shown if the higher limit of the 95% CI for the between-group difference between the half-dose and full-dose groups in the primary endpoint was less than 4 percentage points (corresponding to a maximum relative risk of 1·20). Four interim analyses monitoring the primary and the secondary safety outcomes were done during the study period, using a sequential data analysis method that provided futility and non-inferiority stopping rules and checked for type I and II errors. Interim analyses were done in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT02897076.
Findings: Between Jan 2, 2017, and Oct 9, 2019, 3244 women were randomly assigned to the half-dose (n=1620 [49·9%]) or the full-dose group (n=1624 [50·1%]); 48 women withdrew consent, 30 fetuses were stillborn, 16 neonates were lost to follow-up, and 9 neonates died before evaluation, so that 3141 neonates remained for analysis. In the intention-to-treat analysis, the primary outcome occurred in 313 (20·0%) of 1567 neonates in the half-dose group and 276 (17·5%) of 1574 neonates in the full-dose group (risk difference 2·4%, 95% CI -0·3 to 5·2); thus non-inferiority was not shown. The per-protocol analysis also did not show non-inferiority (risk difference 2·2%, 95% CI -0·6 to 5·1). No between-group differences appeared in the rates of neonatal death, grade 3-4 intraventricular haemorrhage, stage ≥2 necrotising enterocolitis, severe retinopathy of prematurity, or bronchopulmonary dysplasia.
Interpretation: Because non-inferiority of the half-dose compared with the full-dose regimen was not shown, our results do not support practice changes towards antenatal betamethasone dose reduction.
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Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial
International audienceBackgroundAntenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome.MethodsWe designed a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial in 37 level 3 referral perinatal centres in France. Eligible participants were pregnant women aged 18 years or older with a singleton fetus at risk of preterm delivery and already treated with the first injection of antenatal betamethasone (11·4 mg) before 32 weeks’ gestation. We used a computer-generated code producing permuted blocks of varying sizes to randomly assign (1:1) women to receive either a placebo (half-dose group) or a second 11·4 mg betamethasone injection (full-dose group) 24 h later. Randomisation was stratified by gestational age (before or after 28 weeks). Participants, clinicians, and study staff were masked to the treatment allocation. The primary outcome was the need for exogenous intratracheal surfactant within 48 h after birth. Non-inferiority would be shown if the higher limit of the 95% CI for the between-group difference between the half-dose and full-dose groups in the primary endpoint was less than 4 percentage points (corresponding to a maximum relative risk of 1·20). Four interim analyses monitoring the primary and the secondary safety outcomes were done during the study period, using a sequential data analysis method that provided futility and non-inferiority stopping rules and checked for type I and II errors. Interim analyses were done in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT02897076.FindingsBetween Jan 2, 2017, and Oct 9, 2019, 3244 women were randomly assigned to the half-dose (n=1620 [49·9%]) or the full-dose group (n=1624 [50·1%]); 48 women withdrew consent, 30 fetuses were stillborn, 16 neonates were lost to follow-up, and 9 neonates died before evaluation, so that 3141 neonates remained for analysis. In the intention-to-treat analysis, the primary outcome occurred in 313 (20·0%) of 1567 neonates in the half-dose group and 276 (17·5%) of 1574 neonates in the full-dose group (risk difference 2·4%, 95% CI –0·3 to 5·2); thus non-inferiority was not shown. The per-protocol analysis also did not show non-inferiority (risk difference 2·2%, 95% CI –0·6 to 5·1). No between-group differences appeared in the rates of neonatal death, grade 3–4 intraventricular haemorrhage, stage ≥2 necrotising enterocolitis, severe retinopathy of prematurity, or bronchopulmonary dysplasia.InterpretationBecause non-inferiority of the half-dose compared with the full-dose regimen was not shown, our results do not support practice changes towards antenatal betamethasone dose reduction
Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch?
International audienceBackgroundSafety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) during pregnancy.ObjectivesTo describe the characteristics of women initiating pregnancy while on rilpivirine and to compare the outcomes for virologically suppressed subjects continuing rilpivirine until delivery versus switching to an RFC.MethodsIn the ANRS-EPF French Perinatal cohort, we included women on rilpivirine at conception in 2010–18. Pregnancy outcomes were compared between patients continuing versus interrupting rilpivirine. In women with documented viral suppression (<50 copies/mL) before 14 weeks of gestation (WG) while on rilpivirine, we compared the probability of viral rebound (≥50 copies/mL) during pregnancy between subjects continuing rilpivirine versus those switching to RFC.ResultsAmong 247 women included, 88.7% had viral suppression at the beginning of pregnancy. Overall, 184 women (74.5%) switched to an RFC (mostly PI/ritonavir-based regimens) at a median gestational age of 8.0 WG. Plasma HIV-1 RNA nearest delivery was <50 copies/mL in 95.6% of women. Among 69 women with documented viral suppression before 14 WG, the risk of viral rebound was higher when switching to RFCs than when continuing rilpivirine (20.0% versus 0.0%, P = 0.046). Delivery outcomes were similar between groups (overall birth defects, 3.8/100 live births; pregnancy losses, 2.0%; preterm deliveries, 10.6%). No HIV transmission occurred.ConclusionsIn virologically suppressed women initiating pregnancy, continuing rilpivirine was associated with better virological outcome than changing regimen. We did not observe a higher risk of adverse pregnancy outcomes