"GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies"

<p>Abstract</p> <p>Background</p> <p>Gestational Diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.</p> <p>Methods/Design</p> <p>Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the Outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurement4s are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.</p> <p>Discussion</p> <p>The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms.</p> <p>Trial Registration</p> <p>The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number <a href="http://www.clinicaltrials.gov/ct2/show/NCT01058772">NCT01058772</a>.</p

Review of the scientific literature on the health of the Roma and Sinti in Italy.

BACKGROUND: Roma and Sinti in Italy are excluded from the rest of society, often live in precarious housing conditions and have poor access to health services. In Italy, the Roma and Sinti minority (.3% of the overall population) is scarcely represented if compared with other European countries. METHODS: To establish what is known and how Roma and Sinti health is studied in Italy, we conducted a review of the scientific literature, including articles published between 2000 and 2010, found in Medline, Embase and Web of Science. RESULTS: We analyzed 15 relevant articles out of 32 references. Four papers describe rare autosomal recessive disorders. Four illustrate outbreaks of measles. The remaining papers describe health conditions suffered by this minority. All but two, however, are based on data collected at health services. CONCLUSIONS: The lack of prevalence data and analysis of determinants is a detriment to the health of the Roma and Sinti populations in Italy. Participatory research and evidence-based interventions are needed to improve health outcomes and living conditions of the Roma and Sinti peopl

[Muscle and nerve biopsy in ambulatory surgical practice]

The diagnostic value of nerve and muscle biopsy in detecting several neurological diseases is discussed. A bioptic technique for current surgical practice is proposed

Polyneuropathy in hypothyroidism: clinical, electrophysiological and morphological findings in four cases.

Clinical, neurophysiological and morphological studies of four patients with polyneuropathy and secondary hypothyroidism are reported. Neurophysiological studies revealed signs of muscle denervation and reduction of conduction velocity in all the patients. Sural nerve biopsies showed axonal degeneration in all cases but one. All the patients were treated with replacement therapy and clinical symptomatology and neurophysiological parameters improved in all patients

Fat absorption and gastroenteric pH profile in postsurgical pancreatic insufficiency: role of the association of H2-receptor antagonists with pancreatic enzymes

The complete control of steatorrhea in post-surgical exocrine pancreatic insufficiency is difficult. The aim of this study was to evaluate the effect of the association of ranitidine with pancrelipase om fecal fat excretion in patients who had undergone a pancreatoduodenectomy with suppression of the exocrine pancreatic secretion by Neoprene injection. Ten patients were studied 1 year after surgery. Steatorrhea was measured as an integrated test of 3-day stools, while patients were kept on a diet of 100 g lipid/day, with their usual enzyme supplementation therapy (16,050 USP units of lipase/meal). A basal 24-h gastroenteric pH profile was also obtained. In the following month, patients had ranitidine (150 mg twice a day) in addition to pancrelipase. Then steatorrhea and gastroenteric pH were reassessed. Mean fecal fat was 26.9 (SD 13.7) g/day without ranitidine and 30.5 (SD 13.9) g/day during combined treatment. Body weight and nutritional parameters did not show any significant variation after ranitidine administration. Even in the absence of ranitidine, postprandial gastroenteric pH values were always > 4; the H2-receptor antagonist only reduced fasting gastric acidity. In conclusion, the gastroenteric pH and fecal fat determinations showed that ranitidine is not useful in patients with total postsurgical exocrine pancreatic insufficiency

mmediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomised controlled trial

Objective: To evaluate maternal and perinatal outcomes after induction of labour versus expectant management in pregnant women with gestational diabetes at term. Design: Multicentre open-label randomised controlled trial. Setting: Eight teaching hospitals in Italy, Slovenia, and Israel. Sample: Singleton pregnancy, diagnosed with gestational diabetes by the International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGC), between 38+0and 39+0weeks of gestation, without other maternal or fetal conditions. Methods: Patients were randomly assigned to induction of labour or expectant management and intensive follow-up. Data were analysed by ‘intention to treat’. Main outcome measures: The primary outcome was incidence of caesarean section. Secondary outcomes were maternal and perinatal mortality and morbidity. Results: A total of 425 women were randomised to the study groups. The incidence of caesarean section was 12.6% in the induction group versus 11.7% in the expectant group. No difference was found between the two groups (relative risk, RR 1.06; 95% confidence interval, 95% CI 0.64–1.77; P = 0.81). The incidence of non-spontaneous delivery, either by caesarean section or by operative vaginal delivery, was 21.0 and 22.3%, respectively (RR 0.94; 95% CI 0.66–1.36; P = 0.76). Neither maternal nor fetal deaths occurred. The few cases of shoulder dystocia were solved without any significant birth trauma. Conclusions: In women with gestational diabetes, without other maternal or fetal conditions, no difference was detected in birth outcomes regardless of the approach used (i.e. active versus expectant management). Although the study was underpowered, the magnitude of the between-group difference was very small and without clinical relevance. Tweetable abstract: Immediate delivery or expectant management in gestational diabetes at term?