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BACKGROUND: Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity. METHODS: STOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091. FINDINGS: Of 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI -2·1 to 2·9); relative risk 1·0 (95% CI 0·8 to 1·4). There were no clinically significant differences in adverse events between the two groups of the safety population. INTERPRETATION: Among participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin. FUNDING: French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique-Hôpitaux de Paris.
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Trabalho de Parto , Ocitócicos , Recém-Nascido , Gravidez , Feminino , Humanos , Ocitocina/efeitos adversos , Ocitócicos/efeitos adversos , Trabalho de Parto Induzido , MorbidadeRESUMO
BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).
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Antifibrinolíticos/uso terapêutico , Cesárea/efeitos adversos , Hemorragia Pós-Parto/prevenção & controle , Ácido Tranexâmico/uso terapêutico , Administração Intravenosa , Adulto , Antifibrinolíticos/efeitos adversos , Transfusão de Sangue/estatística & dados numéricos , Método Duplo-Cego , Feminino , Humanos , Gravidez , Embolia Pulmonar/etiologia , Ácido Tranexâmico/efeitos adversos , Trombose Venosa/etiologiaRESUMO
INTRODUCTION: The use of different growth charts can lead to confusion in discussions between professionals. There are obstetric charts (of fetal growth) and neonatal charts (of measurements at birth and of postnatal growth). These charts can be descriptive (derived from an unselected population) or prescriptive (derived from of a population at low risk and with optimal conditions for growth). OBJECTIVES: (1) To describe available charts for infants at birth and in the neonatal period and compare them, and (2) to recommend one or more charts for use in neonatology in France. METHODS: Bibliographic research was conducted on MEDLINE and completed by the guidelines of professional societies. RESULTS: Antenatal information about fetal growth restriction or fetuses identified as small-for-gestational-age using Intrauterine charts must be integrated into the identification of newborns at risk, but the use of Intrauterine charts to evaluate birthweight is not recommended to allow consistency with postnatal charts used in neonatal practice. Z-score variations using the updated Fenton postnatal charts are the most appropriate for the assessment of birthweight and postnatal growth for infants born preterm. These charts are sex-specific, include the three measurements (length, weight, and head circumference) and enable longitudinal follow-up of growth up to 50 weeks of corrected age and are linked to the World Health Organization charts at term. The French Audipog charts, although are individualized, accessible online and can be used in maternity units to evaluate birthweight for term infants, but do not allow the follow-up of postnatal growth, while Fenton charts may be used to evaluate birthweight and postnatal growth in the first month for hospitalized term infants. CONCLUSION: The updated Fenton charts are the neonatal charts that best suit the objectives of pediatricians in France for monitoring the growth of preterm newborns. The use of the Audipog charts at term remains an alternative in maternity wards, while Fenton charts can be used for hospitalized term newborns.
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Peso ao Nascer , Gráficos de Crescimento , Humanos , Recém-Nascido , França , Feminino , Desenvolvimento Fetal , Recém-Nascido Pequeno para a Idade Gestacional/crescimento & desenvolvimento , Recém-Nascido Prematuro/crescimento & desenvolvimento , Masculino , Neonatologia/normas , Neonatologia/métodos , Retardo do Crescimento Fetal/diagnóstico , Idade Gestacional , Gravidez , Peso CorporalRESUMO
INTRODUCTION: Obstetric hemorrhage remains a largely preventable cause of maternal mortality globally. The contribution of uterine atony to hemorrhage-related maternal mortality has decreased in France, while the contribution of other causes of obstetric hemorrhage such as surgical injury during cesarean has been reported to increase. However, little evidence exists regarding the risk factors and care processes of women who died from this cause of hemorrhage. Therefore, we aimed to describe the clinical profile, underlying mechanisms, and preventability factors among women who died from obstetric hemorrhage by surgical injury during cesarean section. MATERIAL AND METHODS: Nationwide analysis of all hemorrhage-related maternal deaths by surgical injury during cesarean in France identified by the nationwide permanent enhanced maternal mortality surveillance system (ENCMM) between 2007 and 2018. We described the characteristics of the women, delivery hospitals, circumstances of hemorrhage, features of obstetric and resuscitation/transfusion care, and main preventability factors. RESULTS: Between 2007 and 2018, hemorrhage-related maternal mortality in France decreased from 1.6/100 000 live births (95% CI 1.1-2.2) (39/2 472 650) in 2007-2009 to 0.8/100 000 live births (95% CI 0.5-1.3) (19/2 311 783) in 2016-2018. Hemorrhage-related maternal mortality ratio due to surgical injury during cesarean increased from 0.08 (95% CI 0.01-0.3) (2/2 472 650) to 0.2 (95% CI 0.07-0.5) (5/2 311 783) per 100 000 live births. Among the 18 women who died from surgical injury during cesarean over the 12-year study period, we report a high prevalence of obesity (67%, 12/18), previous cesarean (72%, 13/18), and second-stage cesareans (56%, 10/18). In 22% (4/18), cesarean section was performed in a hospital providing <1000 births annually, with no blood bank (39%, 7/18) or no adult intensive care (44%, 8/18) on-site. Overall preventability of deaths was 94% (17/18). Main preventability factors were related to delay in hemorrhage diagnosis (77%, 14/18) due to late recognition of abnormal parameters (33%, 6/18) and late bedside ultrasound (56%, 10/18), and delay in management due to insufficient surgical skills (56%, 10/18). CONCLUSIONS: In France, surgical injury during cesarean section is an increasing, largely preventable contributor to hemorrhage-related maternal mortality, as other causes of fatal hemorrhage have become less frequent. The profile of these women showed a high prevalence of obesity, previous cesarean, second-stage cesarean, and delivery in hospitals with limited medical and surgical resources, which suggests explanatory mechanisms for the fatal outcome and opportunities for prevention.
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Cesárea , Mortalidade Materna , Hemorragia Pós-Parto , Humanos , Feminino , Cesárea/efeitos adversos , Gravidez , Adulto , França/epidemiologia , Hemorragia Pós-Parto/mortalidade , Fatores de RiscoRESUMO
BACKGROUND: Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. OBJECTIVE: This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. STUDY DESIGN: This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. RESULTS: At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). CONCLUSION: The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures.
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Oclusão com Balão , Hemorragia Pós-Parto , Tamponamento com Balão Uterino , Gravidez , Feminino , Humanos , Hemorragia Pós-Parto/etiologia , Parto Obstétrico/efeitos adversos , Parto Obstétrico/métodos , Ocitocina , Tamponamento com Balão Uterino/efeitos adversosRESUMO
OBJECTIVE: To determine the prevalence of maternal sudden death (MSD) and to compare the characteristics of death between women with explained and unexplained sudden death. DESIGN: A national retrospective study in France. POPULATION: Maternal deaths related to an unexpected sudden cardiac arrest were extracted from the French National Confidential Enquiry into Maternal Deaths database for 2007-2012. METHODS: Maternal, pregnancy, sudden death characteristics and maternal investigations were compared between women with explained and unexplained cause of death. RESULTS: A total of 83 maternal sudden deaths and 4 949 890 live births occurred over the period studied, thus accounting for 16% of all maternal deaths (n = 510). Death was explained in 51 (61%) women and unexplained in 32 women (39%). Compared with women with unexplained death, women with explained death were more often found to have in-hospital cardiac arrest (47% versus 12%, P < 0.01), witnessed cardiac arrest (86% versus 62%, P = 0.03) and in-hospital death (82% versus 47%, P < 0.01). Postmortem investigations such as autopsy and/or CT scan (65% versus 31%, P < 0.01) were also more often carried out in women with explained death. The proportion of deaths for which the preventability factors could not be assessed was 58% among unexplained MSD and 7% among explained MSD. CONCLUSION: Maternal sudden death is a rare event but accounts for a high proportion of all maternal deaths. This highlights the importance of providing training in diagnostic and management strategy for care providers. Systematic postmortem investigations are required to help understand causes and improve practices.
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Morte Materna , Gravidez , Humanos , Feminino , Masculino , Estudos Retrospectivos , Mortalidade Hospitalar , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Mortalidade Materna , Causas de MorteRESUMO
OBJECTIVE: To assess whether standardised longitudinal reporting of growth monitoring information improves antenatal detection of infants who are small for gestational age (SGA), compared with usual care. DESIGN: Cluster-randomised controlled trial. SETTING: Sixteen French level-3 units in 2018-2019. POPULATION: Singleton pregnancies. METHODS: The intervention consisted of the serial plotting of symphysis-fundal height (SFH) and estimated fetal weight (EFW) measurements on customised growth charts using a software program, compared with standard antenatal care. We estimated relative risks (RR) adjusted for known risk factors for fetal growth restriction (FGR). MAIN OUTCOME MEASURES: The primary outcome was antenatal detection of FGR among SGA births (with birthweights below the tenth centile of French customised curves), defined as the mention of suspected FGR in medical records and either referral ultrasounds for growth monitoring or indicated delivery for FGR. Secondary outcomes were false-positive rates, mode of delivery, perinatal morbidity and mortality, and number of antenatal visits and ultrasounds. RESULTS: In total, seven intervention clusters (n = 4349) and eight control clusters (n = 4943) were analysed, after the exclusion of one intervention centre for a major deviation in protocol. SGA births represented 613 (14.1%) and 626 (12.7%) of all births, respectively. The rates of antenatal detection of FGR among SGA births were 40.0% in the intervention arm versus 37.1% in the control arm (crude RR 1.08, 95% CI 0.87-1.34; adj RR 1.09, 95% CI 0.88-1.35). No benefits of the intervention were detected in the analyses of secondary outcomes. CONCLUSIONS: Serial plotting of SFH and EFW measurements on customised growth charts did not improve the antenatal detection of FGR among SGA births.
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Retardo do Crescimento Fetal , Cuidado Pré-Natal , Recém-Nascido , Gravidez , Feminino , Lactente , Humanos , Retardo do Crescimento Fetal/diagnóstico , Retardo do Crescimento Fetal/etiologia , Cuidado Pré-Natal/métodos , Peso Fetal , Idade Gestacional , Recém-Nascido Pequeno para a Idade Gestacional , Fatores de Risco , Parto , Ultrassonografia Pré-NatalRESUMO
BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.
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Antifibrinolíticos , Hemorragia Pós-Parto , Ácido Tranexâmico , Feminino , Gravidez , Humanos , Ácido Tranexâmico/uso terapêutico , Hemorragia Pós-Parto/epidemiologia , Antifibrinolíticos/uso terapêutico , Cesárea/efeitos adversos , Transfusão de SangueRESUMO
RESEARCH QUESTION: Are large ovarian endometriomas associated with high pre-operative anti-Müllerian hormone (AMH) concentrations? DESIGN: Data from 332 women who underwent AMH measurement before surgery for endometriosis were prospectively recorded in a large database. Univariate analysis compared AMH concentrations in terms of the patients' baseline characteristics. A multivariate model was used to identify variables having an independent relationship with AMH concentration. RESULTS: Among 332 women included in the study, 47.6% were aged 18-30 years, 67.8% were infertile and 85.5% were nulliparous. A total of 66.3% had ovarian endometriomas, and 10.8% had cysts measuring over 6 cm. Bilateral cysts over 3 cm were recorded in 24.7% of the women. Univariate analysis identified two variables that had a statistically significant relationship with AMH concentration: the woman's age (Pâ¯=â¯0.01) and cyst size (P < 0.001). Multivariate analysis revealed that ages of 36-40 years and over 40 years showed a significant association with lower AMH concentrations (Pâ¯=â¯0.02 and Pâ¯=â¯0.009, respectively), while a cyst size of over 6 cm was statistically associated with high AMH concentrations (P < 0.001), after adjustment for smoking, parity, rectosigmoid endometriotic nodules and a bilateral location of endometriomas. CONCLUSIONS: Pre-operative AMH concentration was significantly increased in women with large endometriomas of over 6 cm, independent of their age or the presence of bilateral endometriomas. This is relevant for both surgeons and patients when planning surgery in women with an intention to conceive post-operatively.
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Hormônio Antimülleriano/sangue , Endometriose/sangue , Doenças Ovarianas/sangue , Adulto , Endometriose/cirurgia , Feminino , Humanos , Doenças Ovarianas/cirurgia , Reserva Ovariana , Estudos Retrospectivos , Adulto JovemRESUMO
Megacystis-microcolon-intestinal-hypoperistalsis syndrome (MMIHS) is a severe congenital visceral myopathy characterized by an abdominal distension due to a large non-obstructed urinary bladder, a microcolon and intestinal hypo- or aperistalsis. Most of the patients described to date carry a sporadic heterozygous variant in ACTG2. More recently, recessive forms have been reported and mutations in MYH11, LMOD1, MYLK and MYL9 have been described at the molecular level. In the present report, we describe five patients carrying a recurrent heterozygous variant in ACTG2. Exome sequencing performed in four families allowed us to identify the genetic cause in three. In two families, we identified variants in MMIHS causal genes, respectively a nonsense homozygous variant in MYH11 and a previously described homozygous deletion in MYL9. Finally, we identified compound heterozygous variants in a novel candidate gene, PDCL3, c.[143_144del];[380G>A], p.[(Tyr48Ter)];[(Cys127Tyr)]. After cDNA analysis, a complete absence of PDLC3 expression was observed in affected individuals, indicating that both mutated transcripts were unstable and prone to mediated mRNA decay. PDCL3 encodes a protein involved in the folding of actin, a key step in thin filament formation. Presumably, loss-of-function of this protein affects the contractility of smooth muscle tissues, making PDCL3 an excellent candidate gene for autosomal recessive forms of MMIHS.
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Anormalidades Múltiplas/genética , Proteínas de Transporte/genética , Colo/anormalidades , Predisposição Genética para Doença , Pseudo-Obstrução Intestinal/genética , Proteínas do Tecido Nervoso/genética , Bexiga Urinária/anormalidades , Anormalidades Múltiplas/patologia , Feto Abortado , Actinas/genética , Colo/patologia , Feminino , Homozigoto , Humanos , Recém-Nascido , Pseudo-Obstrução Intestinal/patologia , Masculino , Mutação/genética , Cadeias Pesadas de Miosina/genética , Cadeias Leves de Miosina/genética , Linhagem , Bexiga Urinária/patologia , Sequenciamento do ExomaRESUMO
Clubfoot and positional foot deformities (eg, pes spinatus) may have the same aspects on prenatal ultrasound (US) imaging. Nevertheless, differentiating these entities is essential because their prognoses are different. This pictorial review illustrates the US findings of clubfoot and positional foot deformities. On the basis of clinical postnatal images, we describe a prenatal US technique that could give an accurate diagnosis. In this essay, we demonstrate that when a foot malposition is suspected, a systematic analysis with 3 rigorous planes could help differentiate positional foot deformities from malformations and define their types.
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Pé Torto Equinovaro/diagnóstico por imagem , Pé Torto Equinovaro/embriologia , Ultrassonografia Pré-Natal/métodos , Feminino , Pé/diagnóstico por imagem , Pé/embriologia , Deformidades do Pé/diagnóstico por imagem , Deformidades do Pé/embriologia , Humanos , Postura , Gravidez , PrognósticoRESUMO
Importance: Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes. Objective: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. Design, Settings, and Participants: The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation. Interventions: Women who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations. Main Outcomes and Measures: The primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval. Results: Among the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, -∞ to 10.5%; P=.19). Conclusion and Relevance: This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment. Trial Registration: clinicaltrials.gov Identifier: NCT01731431.
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Diabetes Gestacional/tratamento farmacológico , Macrossomia Fetal/prevenção & controle , Glibureto/uso terapêutico , Hiperbilirrubinemia/prevenção & controle , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Administração Oral , Adulto , Glicemia/análise , Diabetes Gestacional/sangue , Feminino , Macrossomia Fetal/etiologia , Glibureto/efeitos adversos , Humanos , Hiperbilirrubinemia/etiologia , Hipoglicemia/induzido quimicamente , Hipoglicemia/etiologia , Hipoglicemiantes/efeitos adversos , Recém-Nascido , Doenças do Recém-Nascido/epidemiologia , Injeções Subcutâneas , Insulina/efeitos adversos , Gravidez , Resultado da GravidezRESUMO
OBJECTIVE: Our aim is to assess the neurodevelopmental outcome of children with a prenatal diagnosis of apparently isolated severe ventriculomegaly (SVM). METHOD: This is a retrospective cohort study from 1994 to 2011. We included fetuses with unilateral or bilateral ventriculomegaly equal to or greater than 15 mm at prenatal ultrasound and confirmed by magnetic resonance imaging, whose parents chose continuation of pregnancy past 22 weeks, and with no associated findings at diagnosis (i.e. no brain malformation or cerebral lesions, normal karyotype, no other congenital abnormalities by ultrasound, and negative toxoplasma, rubella, cytomegalovirus, and herpes test. Children were followed up for at least 2 years. Children were classified into three groups: normal, moderate, or severe abnormalities according to psychomotor developmental stages and/or a visual or hearing impairment and/or behavioral disorders. RESULTS: Twenty-one patients fulfilled the study criteria. SVM was diagnosed at an average gestational age of 30 weeks (range 22-37 weeks). Head circumference was >95th centile in 39% of them. The etiology of SVM was intraventricular hemorrhage in 6 (29%), stenosis of the aqueduct of Sylvius in 3 (14%), and undetermined in 12 (57%). Neurosurgery was performed in four infants, and ventriculoperitoneal shunts were inserted in three. At a mean age at last follow-up of 8.4 years, neurodevelopmental outcome was normal in 62% and moderate and severely impaired in 14% and 24% of children, respectively. There was no association between neurologic outcome and severity of ventricular dilation at prenatal imaging, gestational age at initial diagnosis of SVM, or etiology of the ventricular dilatation. CONCLUSION: The majority of children with apparently isolated SVM show normal neurodevelopmental outcome. No prenatal risk factor identify cases at higher risk for severely abnormal neurologic outcome. © 2017 John Wiley & Sons, Ltd.
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Hidrocefalia/complicações , Transtornos do Neurodesenvolvimento/etiologia , Adulto , Criança , Desenvolvimento Infantil , Feminino , França/epidemiologia , Humanos , Hidrocefalia/diagnóstico por imagem , Hidrocefalia/epidemiologia , Recém-Nascido , Sistema Nervoso/crescimento & desenvolvimento , Transtornos do Neurodesenvolvimento/epidemiologia , Gravidez , Estudos Retrospectivos , Ultrassonografia Pré-NatalRESUMO
Pseudoamniotic band syndrome is a rare complication that occurs after invasive procedures for complicated monochorionic twins. We report 2 cases of intrauterine recipient fetal death after laser therapy for twin-twin transfusion syndrome due to umbilical cord constriction by the amniotic band.
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Síndrome de Bandas Amnióticas/etiologia , Transfusão Feto-Fetal/cirurgia , Fotocoagulação a Laser/efeitos adversos , Placenta/cirurgia , Complicações Pós-Operatórias/diagnóstico por imagem , Cordão Umbilical/patologia , Adulto , Síndrome de Bandas Amnióticas/diagnóstico por imagem , Constrição Patológica , Feminino , Morte Fetal , Fetoscopia , Humanos , Placenta/diagnóstico por imagem , Gravidez , Gêmeos , Ultrassonografia Pré-Natal/métodos , Cordão Umbilical/diagnóstico por imagemRESUMO
INTRODUCTION: The aim of this study was to describe diagnoses and outcomes when women choose to continue a pregnancy despite detection of severe fetal anomaly. MATERIAL AND METHODS: Retrospective study from a French national registry between 2005 and 2009. Various indication groups were classified based on a scale incorporating mortality and morbidity outcomes. Risk factors for perinatal mortality and predictors of neonatal survival were determined by multinomial logistic regression analyses. RESULTS: The overall number of pregnancies that continued after diagnosis of a severe fetal anomaly was 2266 (6.6%). The diagnoses were categorized into life-limiting conditions (34.2%), serious disability anomaly (40.8%), potential intellectual disability (8.6%), other conditions (8.8%), and failure to classify (7.4%). During the study period, there was a significant increase in the number of women who continued pregnancy after their fetus was diagnosed with a life-limiting condition (p = 0.03), and a decrease when the fetus was diagnosed with potential intellectual disability (p = 0.01). Pregnancy outcomes were intrauterine fetal death (17.4%), neonatal mortality (22.3%), neonatal survival (52.7%), or unknown (7.5%). Multinomial logistic regression analysis suggested an increased likelihood of neonatal survival among fetuses diagnosed with serious disability anomaly [59.8%, relative risk (RR) 4.1, 95% CI 3.1-5.7], potential intellectual disability (74.4%, RR 11.5, 95% CI 6.2-21.2), and other conditions (80%, RR 12.6, 95% CI 5.7-27.9) compared with life-limiting conditions (30.1%). CONCLUSIONS: An increasing proportion of women chose to continue pregnancy after the fetus was diagnosed with a potentially life-limiting condition; survival of children with these diagnoses is not uncommon.
Assuntos
Comportamento de Escolha , Anormalidades Congênitas/mortalidade , Anormalidades Congênitas/diagnóstico , Feminino , França/epidemiologia , Humanos , Recém-Nascido , Modelos Logísticos , Gravidez , Diagnóstico Pré-Natal , Sistema de Registros , Estudos Retrospectivos , Fatores de RiscoRESUMO
AIM: To determine whether preterm premature rupture of membranes (PPROM) before 24 weeks is an independent risk factor for poor outcome in preterm neonates. METHODS: A retrospective comparative cohort study was conducted, including viable premature infants born between 25 and 34-weeks gestation. Each preterm case with early PPROM was matched with two preterm controls of the same gestational age at birth, sex and birth date and who were born spontaneously with intact membranes. Logistic regression was performed to identify independent risk factors associated with composite respiratory and perinatal adverse outcomes for the overall population of preterm infants. RESULTS: Thirty-five PPROM cases were matched with 70 controls. Extreme prematurity (26-28 weeks) was an independent risk factor for composite perinatal adverse outcomes [odds ratio (OR) 43.9; p = 0.001]. Extreme prematurity (OR 42.9; p = 0.001), PPROM (OR 7.1; p = 0.01), male infant (OR 5.2; p = 0.02) and intrauterine growth restriction (IUGR, OR 4.8; p = 0.04) were factors for composite respiratory adverse outcomes. CONCLUSION: Preterm premature rupture of membranes before viability represents an independent risk factor for composite respiratory adverse outcomes in preterm neonates. Extreme prematurity may represent the main risk factor for both composite respiratory and perinatal adverse outcomes.
Assuntos
Ruptura Prematura de Membranas Fetais/epidemiologia , Síndrome do Desconforto Respiratório do Recém-Nascido/epidemiologia , Adulto , Feminino , França/epidemiologia , Humanos , Lactente Extremamente Prematuro , Recém-Nascido , Modelos Logísticos , Masculino , Gravidez , Resultado da Gravidez , Estudos Retrospectivos , Adulto JovemRESUMO
Between 2016 and 2018, cardiovascular diseases were responsible for 41 deaths, making it the leading cause of maternal death within 42 days postpartum in France. The maternal mortality ratio (MMR) for cardiovascular disease is 1.8 per 100,000 NV, a non-significant increase compared with the 2013-2015 triennium (MMR of 1.5 per 100,000 NV). Deaths from cardiac causes accounted for the majority (n=28), with 26 deaths secondary to cardiac disease aggravated by pregnancy (indirect deaths) and 2 deaths related to peripartum cardiomyopathy (direct deaths). Deaths from vascular causes (n=13) corresponded to 9 aortic dissections and 4 ruptures of large vessels, including 3 ruptures of the splenic artery. Preventability of death (possible or probable) was found in 56% of cases compared with 66% in the previous triennium. Care was considered sub-optimal in 57% of cases, down from 72% in the 2013-2015 triennium. In women with known cardiovascular disease, the areas for improvement concern multidisciplinary follow-up, repeated assessment of the cardiovascular risk (WHO grade) and early referral to an expert centre (expert cardiologists, obstetricians, anaesthetists and intensive care). In all pregnant women or women who have recently given birth, a cardiovascular etiology should be considered in the presence of suggestive symptoms (dyspnea, chest or abdominal pain). Ultrasound "point of care" examination (fluid effusions, cardiac dysfunction) and cardiac enzymes assay can help in the diagnosis. Finally, the woman must be involved in her own care.
Assuntos
Doenças Cardiovasculares , Morte Materna , Feminino , Gravidez , Humanos , Mortalidade Materna , Morte Materna/etiologia , Período Pós-Parto , França/epidemiologiaRESUMO
In France, 272 maternal deaths occurred during the period 2016-2018, of which 131 were initially treated by healthcare professionals not specialized in obstetric. Fifty-six files were excluded because they did not concern emergency services or because there was insufficient data to allow analysis. Seventy-five cases of maternal deaths initially treated by emergency services (in-hospital emergency department [ED] or emergency medical ambulance [SAMU]) were analyzed. Fifty-six cases were treated by the SAMU and 22 by an ED (both in 3 cases). The causes of death were 20 cardiovascular events, 18 pulmonary embolisms, 9 neurological failures and 8 hemorrhagic shocks. The event occurred during pregnancy in 48 cases (64%) and during per or postpartum period in 27 cases (36%). The motivations for consultation at the ED were mainly pain (n=9), respiratory distress (n=6) or faintness (n=3). The reasons for calling emergency dispatching service (SAMU) were cardiorespiratory arrest in 32 cases (57%) and neurological failure (coma or status epilepticus) in 6 cases (11%). Among the 56 patients treated outside the hospital, 17 died on scene and 39 were transported to a resuscitation room (n=13), a specialized department (n=13), an obstetrics department (n=8) and less often in the ED (n=2). This was considered appropriate in 35 out of 39 cases (90%). Concerning the 75 files analyzed (ED and SAMU), death was considered unavoidable in 37 cases (49%) and potentially avoidable in 29 cases (38%) (maybe=23, probably=6). Avoidability could not be established in 9 cases. Among the 29 potentially avoidable deaths (38%), one of the criteria of avoidability concerned emergency services in 14 cases (ED=9, SAMU/SMUR=5, 18% of the files studied). ED's cares were considered optimal in 11 cases (50%) and non-optimal in 11 cases (50%). SAMU's cares were considered optimal in 45 cases (80%).
Assuntos
Serviços Médicos de Emergência , Morte Materna , Gravidez , Feminino , Humanos , Morte Materna/etiologia , Serviço Hospitalar de Emergência , Hospitais , França/epidemiologiaRESUMO
OBJECTIVES: There is a progressive reduction in the rate of episiotomies since the recommendations of the French college of gynaecologists. Our objective was to study the evolution of the rate of episiotomies and Obstetric Anus Sphincter Injury (OASI) since the restriction of episiotomies in our department. METHODS: Observational monocentric retrospective study performed at the Rouen University Hospital. The inclusion criteria were monofetal pregnancies, delivery at a term greater than or equal to 37 weeks of amenorrhea of a living, viable child and by cephalic presentation. We compared two periods corresponding to before and after the 2018 recommendations. We used logistic regression modelling to identify factors associated with the risk of episiotomies and of obstetrical anal injuries, overall and in case of instrumental delivery. RESULTS: We included 3329 patients for the 1st period and 3492 for the 2nd period, and the rate of instrumental deliveries were respectively of 16.4% (n=547) and 17.9% (n=626). Multivariate analysis showed a significant decrease in the rate of episiotomies in the 2nd period (OR 0.14, CI 95% [0.12; 0.16], P<0.0001). Main factors associated with the risk of OASI were primiparity (OR 6.21, CI 95% [3.19; 12.11]) and the use of forceps (OR 4.23, CI 95% [2.17; 8.27]) overall; and instrumental delivery using forceps (OR 3.25, CI 95% [1.69; 6.22]) and delivery during the 2nd period (OR 1.98, CI 95% [1.01; 3.88]) in case of instrumental delivery. CONCLUSIONS: Our study confirms that the voluntary reduction in the episiotomy rate does not seem to be associated with an increased risk of OASI, overall and in case of instrumental delivery. However, we show an increase in the rate of OASI in case of instrumental delivery since the latest recommendations.
Assuntos
Episiotomia , Complicações do Trabalho de Parto , Feminino , Humanos , Gravidez , Canal Anal/lesões , Parto Obstétrico/efeitos adversos , Episiotomia/efeitos adversos , Complicações do Trabalho de Parto/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Recém-NascidoRESUMO
Between 2016 and 2018, 20 maternal deaths were related to obstetric haemorrhage, excluding haemorrhage in the first trimester of pregnancy, representing a mortality ratio of 0.87 per 100,000 live births (95% CI 0.5 -1.3). Obstetric haemorrhage is the cause of 7.4% of all maternal deaths up to 1 year, 10% of maternal deaths within 42days, and 21% of deaths directly related to pregnancy (direct causes). Between 2001 and 2018, maternal mortality from obstetric haemorrhage has been considerably reduced, from 2.2deaths per 100,000 live births in 2001-2003 to 0.87 in the period presented here. Nevertheless, obstetric haemorrhage is still one of the main direct causes of maternal death, and remains the cause with the highest proportion of deaths considered probably (53%) or possibly (42%) preventable according to the CNEMM's collegial assessment (see chapter 3). The preventable factors reported are related to inadequate content of care in 94% of cases and/or organisation of care in 44% of cases. In this triennium, maternal death due to haemorrhage occurred mainly in the context of caesarean delivery (65% of cases, i.e. 13/20), and mostly in the context of emergency care (12/13). The main causes of obstetric haemorrhage were uterine rupture (6/20) in unscarred uterus or in association with placenta accreta, and surgical injury during the caesarean delivery (5/20). Every maternity hospital, whatever its resources and/or technical facilities, must be able to plan any obstetric haemorrhage situation that threatens the mother's vital prognosis. Intraperitoneal occult haemorrhage following caesarean section and uterine rupture require immediate surgery with the help of skilled surgeon resources with early and appropriate administration of blood products.