Winter H.,Pediatric GI Unit |
Gunasekaran T.,Loyola University |
Tolia V.,Providence Hospital |
Gottrand F.,Jeanne Of Flandre University Hospital |
And 2 more authors.
Journal of Pediatric Gastroenterology and Nutrition | Year: 2012
Objectives: Gastroesophageal reflux disease (GERD) is present in pediatric patients when reflux of gastric contents causes troublesome symptoms and/or complications. The present study evaluates the efficacy and safety of esomeprazole in infants ages 1 to 11 months with GERD. Methods: In this multicenter randomized, double-blind, placebo-controlled, parallel-group, treatment-withdrawal study, infants received open-label, weight-adjusted doses of esomeprazole (2.5-10mg) once daily for 2 weeks. Infants with symptom improvement were randomized to esomeprazole (weight-adjusted doses [2.5-10 mg]) or placebo for 4 weeks. The primary endpoint was time to discontinuation owing to symptom worsening based on global assessments by the parent/guardian and physician. Adverse events were recorded. Results: Of the 98 patients enrolled, 81 (82.7%) experienced symptom improvement determined by physician global assessment (PGA) during open-label esomeprazole treatment; 80 entered the double-blind phase. During this phase, discontinuation rates owing to symptom worsening were 48.8% (20/41) for placebo-treated versus 38.5% (15/39) for esomeprazole-treated patients (hazard ratio 0.69; P=0.28). Posthoc analysis of infants with symptomatic GERD (ie, no diagnostic procedure performed) revealed that time to discontinuation was significantly longer with esomeprazole than placebo (hazard ratio 0.24; P=0.01); the complementary subgroup difference was not significant (hazard ratio 1.39; P=0.48). Esomeprazole was well tolerated. Conclusions: The discontinuation rate owing to symptom worsening did not differ significantly between infants receiving esomeprazole versus those receiving placebo. Improved diagnostic criteria in this age group are needed to identify infants with GERD who may benefit from acid suppression therapy. Copyright © 2012 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Source
Jacquetin B.,Estaing University Hospital Center |
Hinoul P.,Medical Affairs |
Gauld J.,Clinical Development |
Fatton B.,Estaing University Hospital Center |
And 7 more authors.
International Urogynecology Journal and Pelvic Floor Dysfunction | Year: 2013
Introduction and hypothesis To evaluate clinical effectiveness and complication rates at 5 years following the total Trans Vaginal Mesh (TVM) technique to treat pelvic organ prolapse. Methods Prospective, observational, multi-centre study in patients with prolapse of stage II or higher. Results Of the 90women enrolled in the study, 82 (91%)were available for the 5-year follow-up period. At the 5-year endpoint, success, defined as no surgical prolapse reintervention and leading edge <-1 (International Continence Society [ICS] criteria) or above the level of the hymen, was 79 % and 87 % respectively. A composite criterion of success defined as: leading edge above the hymen (<0) and no bulge symptoms and no reintervention for prolapse was met by 90 %, 88% and 84%at the 1-, 3-, and 5-year endpoints respectively. Quality of life improvement was sustained over the 5 years. Over the 5-year follow-up period, a total of only 4 patients (5 %) required re-intervention for prolapse, while a total of 14 patients (16 %) experienced mesh exposure for which 8 resections needed to be performed. Seven exposures were still ongoing at the 5-year endpoint, all asymptomatic. Only 33 out of 61 (54 %) sexually active patients at baseline remained so at 5 years. De novo dyspareunia was reported by 10 %, but no new cases at the 5-year endpoint. One patient reported de novo unprovoked mild pelvic pain at 5 years, 5 reported pains during pelvic examination only. Conclusions Five-year results indicated that TVM provided a stable anatomical repair. Improvements in QOL and associated improvements in prolapse-specific symptoms were sustained. Minimal new morbidity emerged between the 1- and 5-year follow-up. © The International Urogynecological Association 2013. Source
Heuschkel R.B.,University of Cambridge |
Gottrand F.,Jeanne Of Flandre University Hospital |
Devarajan K.,University of Cambridge |
Poole H.,University of Cambridge |
And 13 more authors.
Journal of Pediatric Gastroenterology and Nutrition | Year: 2015
OBJECTIVES:: This European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) position statement provides a comprehensive guide for health care providers to manage percutaneous endoscopic gastrostomy tubes in a safe, effective, and appropriate way. METHODS:: Relevant literature from searches of PubMed, CINAHL, and recent guidelines was reviewed. In the absence of evidence, recommendations reflect the expert opinion of the authors. Final consensus was obtained by multiple e-mail exchange and during 3 face-to-face meetings of the gastroenterology committee of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. RESULTS:: Endoscopically placed gastrostomy devices are essential in the management of children with feeding and nutritional problems. The article focuses on practical issues such as indications and contraindications. CONCLUSIONS:: The decision to place an endoscopic gastrostomy has to be made by an appropriate multidisciplinary team, which then provides active follow-up and care for the child and the device. © 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Source
Deneux-Tharaux C.,University Pierre and Marie Curie |
Sentilhes L.,University of Angers |
Maillard F.,University Pierre and Marie Curie |
Closset E.,Jeanne Of Flandre University Hospital |
And 4 more authors.
BMJ (Online) | Year: 2013
Objective: To assess the impact of controlled cord traction on the incidence of postpartum haemorrhage and other characteristics of the third stage of labour in a high resource setting. Design: Randomised controlled trial. Setting: Five university hospital maternity units in France. Participants: Women aged 18 or more with a singleton fetus at 35 or more weeks' gestation and planned vaginal delivery. Interventions: Women were randomly assigned to management of the third stage of labour by controlled cord traction or standard placenta expulsion (awaiting spontaneous placental separation before facilitating expulsion). Women in both arms received prophylactic oxytocin just after birth. Main outcome measure: Incidence of postpartum haemorrhage ≥500 mL as measured in a collector bag. Results: The incidence of postpartum haemorrhage did not differ between the controlled cord traction arm (9.8%, 196/2005) and standard placenta expulsion arm (10.3%, 206/2008): relative risk 0.95 (95% confidence interval 0.79 to 1.15). The need for manual removal of the placenta was significantly less frequent in the controlled cord traction arm (4.2%, 85/2033) compared with the standard placenta expulsion arm (6.1%, 123/2024): relative risk 0.69, 0.53 to 0.90); as was third stage of labour of more than 15 minutes (4.5%, 91/2030 and 14.3%, 289/2020, respectively): relative risk 0.31, 0.25 to 0.39. Women in the controlled cord traction arm reported a significantly lower intensity of pain and discomfort during the third stage than those in the standard placenta expulsion arm. No uterine inversion occurred in either arm. Conclusions: In a high resource setting, the use of controlled cord traction for the management of placenta expulsion had no significant effect on the incidence of postpartum haemorrhage and other markers of postpartum blood loss. Evidence to recommend routine controlled cord traction for the management of placenta expulsion to prevent postpartum haemorrhage is therefore lacking. Trial registration ClinicalTrials.gov NCT01044082. Source
Sentilhes L.,University of Angers |
Lasocki S.,University of Angers |
Ducloy-Bouthors A.S.,Jeanne Of Flandre University Hospital |
Deruelle P.,Jeanne Of Flandre University Hospital |
And 5 more authors.
British Journal of Anaesthesia | Year: 2015
Postpartum haemorrhage (PPH) is a major cause of maternal mortality, accounting for one-quarter of all maternal deaths worldwide. Uterotonics after birth are the only intervention that has been shown to be effective for PPH prevention. Tranexamic acid (TXA), an antifibrinolytic agent, has therefore been investigated as a potentially useful complement to this for both prevention and treatment because its hypothesized mechanism of action in PPH supplements that of uterotonics and because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. This review covers evidence from randomized controlled trials (RCTs) for PPH prevention after caesarean (n=10) and vaginal (n=2) deliveries and for PPH treatment after vaginal delivery (n=1). It discusses its efficacy and side effects overall and in relation to the various doses studied for both indications. TXA appears to be a promising drug for the prevention and treatment of PPH after both vaginal and caesarean delivery. Nevertheless, the current level of evidence supporting its efficacy is insufficient, as are the data about its benefit:harm ratio. Large, adequately powered multicentre RCTs are required before its widespread use for preventing and treating PPH can be recommended. © 2015 The Author. Source