35 research outputs found

    Systematic Kleihauer–Betke Test after External Cephalic Version for Breech Presentation: Is It Useful?

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    The incidence of fetomaternal hemorrhage (FMH) after external cephalic version (ECV) has been poorly reported. In this study, we evaluated the frequency of FMH, diagnosed by positive Kleihauer–Betke test (KBT), after ECV attempt and then evaluate the relevance of its routine use after procedure. A total of 282 women with a term breech presentation and who had ECV attempt were recruited from January 2014 and December 2018. After ECV attempt, women were systematically screened for FMH using KBT. Data on ECV attempt, KBT results, perinatal and neonatal outcomes were collected and compared between women with positive (cases) and negative KBT (controls) after ECV. The success rate of ECV was 22.0% (62/282). Eight women (2.9%) experienced transient fetal heart rate (FHR) abnormalities after ECV. In five (1.8%) women, KBT was positive after ECV. Obstetrical management was modified for two of these five women due to continuous positivity of KBT at day 1 and day 7 controls after ECV attempt. A cesarean section was planned 7 days earlier due to persistent high FMH on day 7 (6 mL fetal blood) in one woman and the labor was induced for persistent high FMH on day 7 (20 mL fetal blood) for another woman. No newborns have signs of fetal anemia at birth and there was no significant difference in neonatal status between two groups. FMH after ECV attempt are rare, and no negative fetal or neonatal outcomes were observed when KBT was positive, even strongly (>5 mL fetal blood). It appears that systematic KBT after attempted ECV is probably not useful

    Neonatal Morbidity after Cervical Ripening with a Singleton Fetus in a Breech Presentation at Term

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    Vaginal delivery in women with a breech presentation is part of common practice in France despite much debate, and the induction of labor (IOL) with a fetus in a breech presentation at term remains uncommon. Little is known about the effectiveness of cervical ripening and its neonatal and maternal safety in these women. We present a retrospective study of 362 women who gave birth to a live singleton fetus in a breech presentation at term. The objective was to compare severe maternal and neonatal morbidity according to the planned mode of labor (spontaneous labor or the induction of labor (IOL) with a favorable cervix, cervical ripening, or elective cesarean delivery) and, specifically, to compare cervical ripening to the other modes of labor. The rate of severe neonatal morbidity was 3.0% and was significantly higher after the IOL compared to elective cesarean delivery (p = 0.02), and the severe maternal morbidity rates were similar. Multivariable logistic regression analysis found no significant association between cervical ripening and either composite severe neonatal (adjusted odds ratio [aOR] 2.80, 95% confidence interval [CI] 0.10–43.6) or maternal morbidity (aOR 1.29, 95% CI 0.05–11.5). Our results support a policy of offering cervical ripening to the appropriately selected candidates with a singleton fetus in a breech presentation at term without increasing the incidence of severe maternal and neonatal morbidity

    A Prospective Study of Association of Micronutrients Deficiencies during Pregnancy and Neonatal Outcome among Women after Bariatric Surgery

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    Little is known about the association of micronutrients deficiencies during pregnancy and neonatal outcome among women after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). We present a prospective study of 87 consecutive women with a history of RYGB (n = 37) or SG (n = 50) who underwent complete and regular clinical and biological nutritional assessments during pregnancy. Data on maternal characteristics, biological nutritional parameters, antenatal management, and perinatal outcome were collected. The objective was to evaluate serum levels of micronutrients at the second trimester, and to assess the association between micronutrients deficiencies and neonatal outcome. After RYGB, maternal age (34.3 ± 4.9 vs. 31.1 ± 4.6 years; p = 0.003) and pregnancy timing after surgery (64.5 ± 47.0 vs. 38.1 ± 28.1 months; p = 0.002) were significantly higher, and pre-pregnancy BMI was significantly lower (29.8 ± 5.6 vs. 32.9 ± 7.1 kg/m2; p = 0.03). Maternal and neonatal outcomes were similar. Additional supplementations after blood tests were similar in groups. Zinc, selenium, vitamins A1, B1, B6, C, and E levels were not different depending on the type of surgery. Zinc deficiency (7/87) was significantly more frequent after RYGP (18.9% vs. 0%; p = 0.02) and selenium deficiency (15/87) was similar in groups (21.6% after RYGB and 14.0% after SG; p = 0.36). The mean birth weight was significantly lower in selenium deficiency cases (3137 ± 550 vs. 3535 ± 737 g; p = 0.04). Selenium deficiency was negatively correlated with birth weight (r = −0.23; p = 0.03) and with birth weight z-score (r = −0.26; p = 0.01), but not correlated after adjustment for the procedure. The levels of micronutrients surveillance along pregnancy in women with a history of bariatric surgery is necessary to decrease the risk of inadequate fetal growth in the patients

    Gingival biotype: The probe test utility

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    Evaluation of the impact of non-slip socks on the motor recovery of elderly people in acute care hospitals: Protocol for a randomized, controlled trial study.

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    BackgroundOlder patients often arrive in acute care wards with inappropriate footwear. Hospitals may provide non-slip socks to improve the patients' safety. However, few studies have been conducted on the benefits of non-slip socks. A recent literature review found only two randomized controlled studies that evaluated non-slip socks, but the socks were not the primary focus of the studies. The aim of this study is therefore to specifically evaluate the benefits of non-slip socks on gait in hospitalized older people.MethodsThis open, randomized, controlled trial will include patients aged 75 years and over, hospitalized in an acute medical unit. Patients will be randomized to either remain barefoot or wear non-slip socks throughout their stay. The primary outcome is gait speed, assessed on Day 1 and Day 8.DiscussionThis randomized controlled trial should provide clinicians with a scientific rational for the recommendation, or not, of the use of non-slip socks for older patients in acute care hospitals.Trial registrationhttps://clinicaltrials.gov/ on May 12, 2021 under the reference: NCT04882696 https://clinicaltrials.gov/ct2/show/NCT04882696

    Tocilizumab in combination with a standard induction chemotherapy in acute myeloid leukaemia patients (TOCILAM study): a single-centre, single-arm, phase 1 trialResearch in context

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    Summary: Background: In acute myeloid leukaemia (AML), interleukin-6 (IL-6) promotes chemo-resistance and its levels correlate with poor prognosis. IL-6 blockade may represent a promising therapeutic strategy. We aimed to test, tocilizumab, an anti-IL-6 receptor (R) monoclonal antibody in combination with standard intensive AML induction chemotherapy. Methods: This investigator-initiated single-centre phase 1 trial was conducted at Nantes University Hospital in France. According to a continual reassessment method, three escalating doses were tested of intravenous (IV) tocilizumab (4, 6, and 8 mg/kg) administered at day (d) 8 of a standard AML induction chemotherapy (IV idarubicine 8 mg/m2 d1 to d5 + IV cytarabine 100 mg/m2 d1 to d7). All adults (aged ≄ 18 years) with an Eastern Cooperative Oncology Group performance status of 0–2 and with a newly diagnosed (excluding patients with a favourable risk according to ELN-2017 classification if <60 year-old) or a relapsed/refractory AML were eligible. The primary objective was to determine the maximum tolerated dose of tocilizumab to administrate with a standard intensive AML induction. Safety outcomes were continuously monitored for at each participant contact. This trial is registered with ClinicalTrials.gov, NCT04547062. Findings: Between Dec 29, 2020 and Dec 1, 2022, 12 patients were enrolled, of whom 75% had an ELN-2017 high-risk profile, and were treated with tocilizumab— two patients at 4 mg/kg, two at 6 mg/kg and eight at 8 mg/kg of tocilizumab. No dose-limiting toxicity related to tocilizumab was documented. There were nine serious adverse events, none of which were related to tocilizumab, and there was no treatment-related deaths. MTD was thus not reached. Two deaths occurred during induction. In the remaining ten evaluable patients, nine responded to treatment. Interpretation: The combination of tocilizumab with standard AML intensive induction appears to be safe and resulting responses are encouraging. A dose of 8 mg/kg of tocilizumab given at day 8 of induction could be used for further phase 2/3 studies. Funding: The LeucĂ©mie Espoir Atlantique Famille (LEAF)—“Tous avec Fabien” association

    Lenalidomide in combination with melphalan and dexamethasone in patients with newly-diagnosed AL amyloidosis: a multicenter phase 1/2 dose escalation study.

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    International audienceNew treatment options are required for primary systemic AL amyloidosis (AL). This phase 1 / 2 dose-escalation study aimed to determine the maximum tolerated dose (MTD) of lenalidomide in combination with melphalan and dexamethasone (M-dex), and to assess the efficacy and tolerability of this therapy for patients with de novo AL. Twenty-six patients were enrolled across 4 cohorts: M-dex plus lenalidomide 5, 10, 15 and 20 mg once daily on days 1-21 in a 28-day cycle. No DLT was observed in cohort n degrees 1, 2 and 3. Four patients / 7 in cohort n degrees 4, M-dex + lenalidomide 20 mg/day, experienced dose-limiting toxicity. 15 mg lenalidomide was defined as MTD. A complete hematologic response was achieved in 42% at the dose of 15 mg of lenalidomide / day. After a median follow-up of 19 months, estimated 2-year overall survival and event-free survival (EFS) were 80.8% and 53.8%, respectively. Hematologic and organ responses were both associated with superior EFS rates (P = .0001). A higher EFS was also observed in patients whose free light chains decreased by more than 50% during therapy (P = .019). Lenalidomide 15 mg/day plus M-dex is a new effective combination therapy in patients with newly diagnosed AL. This study is registered at http://clinicaltrials.gov as NCT00621400
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