130 research outputs found

    Trends in cerclage use

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    INTRODUCTION: The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are undergoing this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage. MATERIAL AND METHODS: We conducted a retrospective cohort study of women who underwent cerclage for prevention of preterm birth in the Division of Maternal and Fetal Medicine of Thomas Jefferson University Hospital (Philadelphia, USA) over a 16-year period, from 1998 to 2013. We included women with singleton gestations who had a history-indicated (HIC) or ultrasound-indicated cerclage (UIC). Physical examination-indicated cerclage and transabdominal cerclage were excluded. We planned to compare data before and after 2005. RESULTS: From 1998 to 2013, there were 33 353 deliveries, of which 16 871 occurred from 1998 to 2005 and 16 482 from 2006 to 2013. Of all deliveries, 328 women (1.0%) received HIC or UIC, and were therefore included in the analysis. Between 1998-2005 and 2006-2013 there were significant decreases in the overall rate of cerclage (1.4% to 0.6%; p < 0.001), as well as the rate of HIC (0.8% to 0.2%; p < 0.001) and UIC (0.6% to 0.3%; p < 0.001). CONCLUSIONS: During the last 16 years, the overall rate of HIC and UIC cerclage at Thomas Jefferson University Hospital significantly declined from 1.4% to 0.6%; significant decreases were seen for both HIC and UIC. The reason for the lower rate of cerclages may be the recently published evidence

    Tranexamic acid for preventing postpartum blood loss after cesarean delivery: A systematic review and meta-analysis of randomized controlled trials

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    INTRODUCTION: There are several published clinical trials of the use of tranexamic acid (TXA) in an obstetric setting, but no consensus on its use or guidelines for management. MATERIAL AND METHODS: The aim of this meta-analysis was to evaluate the effectiveness of TXA in reducing blood loss when given prior to cesarean delivery. We performed a systematic search in electronic databases. We included all randomized controlled trials comparing the use of TXA prior to cesarean delivery with controls (either placebo or no treatment). RESULTS: Nine trials with 2365 women were included in the analysis. Women who received TXA had significantly less postpartum blood loss, a lower drop in hemoglobin and a lower incidence of postpartum hemorrhage and severe postpartum hemorrhage compared with controls. Moreover, the number of women who needed additional uterotonic agents was significantly lower in the TXA group than in controls. The percentage of women who required blood transfusions at, or immediately after, cesareans was significantly lower in the intervention group than in the controls. There was no difference in the incidence of thromboembolic events in the two groups. CONCLUSIONS: Prophylactic TXA given before cesarean skin incision in women undergoing cesarean delivery, under spinal or epidural anesthesia, significantly decreases blood loss, including postpartum hemorrhage and severe postpartum hemorrhage, in addition to the standard prophylactic oxytocin given after delivery of the neonate. The effect of TXA on thromboembolic events and mortality as well as its use in high-risk women should be investigated further

    Cervical lacerations in planned versus labor cerclage removal: A systematic review

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    OBJECTIVE: The aim of this study was to evaluate the incidence of cervical lacerations with cerclage removal planned before labor compared to after the onset of labor by a systematic review of published studies. STUDY DESIGN: Searches were performed in electronic databases from inception of each database to November 2014. We identified all studies reporting the rate of cervical lacerations and the timing of cerclage removal (either before or after the onset of labor). The primary outcome was the incidence of spontaneous and clinically significant intrapartum cervical lacerations (i.e. lacerations requiring suturing). RESULTS: Six studies, which met the inclusion criteria, were included in the analysis. The overall incidence of cervical lacerations was 8.9% (32/359). There were 23/280 (6.4%) cervical lacerations in the planned removal group, and 9/79 (11.4%) in the removal after labor group (odds ratio 0.70, 95% confidence interval 0.31-1.57). CONCLUSIONS: In summary, planned removal of cerclage before labor was not shown to be associated with statistically significant reduction in the incidence of cervical lacerations. However, since that our data probably did not reach statistical significance because of a type II error, further studies are needed

    VAL-1221 for the treatment of patients with Lafora disease: study protocol for a single-arm, open-label clinical trial

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    Introduction Lafora disease (LD) is an ultrarare fatal progressive myoclonic epilepsy, causing drug-resistant epilepsy, myoclonus and psychomotor deterioration. LD is caused by mutations in EPM2A or NHLRC1, which lead to the accumulation of polyglucosans in the brain and neurodegeneration. There are no approved treatments for LD. VAL-1221 is a fusion protein comprising the Fab portion of a cell-penetrating antibody and recombinant human acid alpha glucosidase, and has demonstrated an ability to clear polyglucosans. We hypothesise that intravenous infusion of VAL-1221 might be able to degrade cerebral polyglucosans and stabilise or improve disease outcomes. The aim of this study is to assess the safety and preliminary efficacy of VAL-1221 in patients with LD.Methods and analysis The study is a phase 2, single-arm, open-label, baseline-controlled clinical trial which will be conducted in a single investigational study centre in Italy, namely the sponsor 'IRCCS Istituto delle Scienze Neurologiche di Bologna-Azienda USL di Bologna'. The study will enrol six genetically confirmed patients with mid- to late-stage LD. The global duration of the study for each participant will be 18 months, including screening period, open-label treatment (12 months) and follow-up period. VAL-1221 20 mg/kg will be administered as an intravenous infusion every week for 3 weeks, then every other week. Patients will undergo full clinical assessments at baseline, at an intermediate and at the end-of-treatment visit. The primary objective is to evaluate the safety. The exploratory efficacy endpoints will be related to epilepsy, neuropsychological and motor functions, global assessment and disease burden, in addition to biomarkers. Statistical analyses will be primarily descriptive.Ethics and dissemination The study protocol was approved by the local ethics committee (number 232-2023-FARM-AUSLBO-23020, 22 March 2023). The results of this study will be disseminated by the investigators through presentations at international scientific conferences and reported in peer-reviewed scientific journals.Trial registration number European Union Clinical Trials Register (EudraCT 2023-000185-34)

    Fetal cerebellar damage in fetuses with severe anemia undergoing intrauterine transfusions

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    Objective: To evaluate radiologic findings and outcomes of cerebellar injuries in fetuses with severe anemia due to RhD alloimmunization undergoing intrauterine transfusions.Methods: Imaging of multiplanar neurosonography and magnetic resonance imaging (MRI) were reviewed. Pregnancy outcomes were recorded.Results: Cerebellar injuries were identified after the first intravascular transfusion in four fetuses. Two of these cases were previously reported. The median hemoglobin concentration was 2.1 g/dL. Prenatal neurosonography identified an echogenic collection involving the cerebellum suggestive for hemorrhage in three cases. A progressive hypoplasia of a hemisphere was demonstrated at follow-up examination in one of these cases. Hypoplasia of a cerebellar hemisphere was seen in the fourth fetus. Ultrasound diagnosis was confirmed by prenatal MRI in two cases. In the third case, the postnatal MRI showed as additional finding vermian involvement. One pregnancy was terminated and autopsy confirmed the presence of infratentorial hemorrhage. The remaining infants were delivered alive. At time of writing, a truncal ataxia was diagnosed in the child with vermian hypoplasia, while the other children have met all age-appropriate milestones.Conclusions: A severe anemia seems to put the fetus at risk of cerebellar damage, despite successful intravascular transfusion
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