Progress of the Dutch Spinal Cord Injury Database:Completeness of Database and Profile of Patients Admitted for Inpatient Rehabilitation in 2015

Background: In the Dutch International Spinal Cord Injury (SCI) Data Sets project, we translated all International SCI Data Sets available in 2012 and created a Dutch SCI Database (NDD). Objective: To describe the number of included patients and completeness of the NDD, and to use the NDD to provide a profile of people with traumatic SCI (T-SCI) and non-traumatic SCI (NT-SCI) in the Netherlands. Methods: The NDD includes patients admitted for their first inpatient rehabilitation after onset of SCI to 1 of the 8 rehabilitation centers with a specialty in SCI rehabilitation in the Netherlands. Data of patients admitted in 2015 were analyzed. Results: Data for 424 patients were available at admission; for 310 of these patients (73.1%), discharge data were available. No significant differences were found between patients with and without data at discharge. Data were nearly complete (>90%) for lower urinary tract, bowel, pain, and skin. Data on sexual function has the lowest completion rate. Complete neurological and functional data were available for 41.7% and 38%, respectively. Most patients were male (63.4%), had NT-SCI (65.5%), and had incomplete SCI (58.4% D). Patients with T-SCI differed from patients with NT-SCI on most characteristics, and they stayed considerably longer in the rehabilitation center (112 days vs 65 days, p < .001). Place of discharge was not different between both groups. Conclusion: With the NDD, we collect important data on the majority of Dutch SCI patients, although much work needs to be done to improve the completeness of the data collection

Induction of labour with a Foley catheter or oral misoprostol at term:the PROBAAT-II study, a multicentre randomised controlled trial

<p>Background: Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness.</p><p>Methods/Design: We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women's preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome.</p><p>Discussion: Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines.</p>