After shoulder dystocia: managing the subsequent pregnancy and delivery

Among risk factors for shoulder dystocia, a prior history of delivery complicated by shoulder dystocia is the single greatest risk factor for shoulder dystocia occurrence, with odds ratios 7 to 10 times that of the general population. Recurrence rates have been reported to be as high as 16%. Whereas prevention of shoulder dystocia in the general population is neither feasible nor cost-effective, intervention efforts directed at the particular subgroup of women with a prior history of shoulder dystocia can concentrate on potentially modifiable risk factors and individualized management strategies that can minimize recurrence and the associated significant morbidities and mortality.     

Shoulder dystocia

Using an evidence-based, medical approach, the strengths and pitfalls of the causation- and standard-of-care-based arguments proffered by plaintiff and defense counsel in shoulder dystocia- associated birth injury litigation are reviewed based on medical plausibility. The role of the expert witness as arbiter of the relationship between medical care rendered and the untoward outcome of such care is distinguished from that of other court members. Proposed solutions to the medical malpractice litigation crisis are also examined in light of relevant differences in the pathogenetic bases for birth injuries of various types.     

Über das bösartige Neuroblastom des Sympathicus

Ohne ZusammenfassungMit 3 Textabbildungen.     

Randomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance)

BackgroundAnthracycline use in metastatic breast cancer (MBC) is hindered by cumulative exposure limits and risk of cardiotoxicity. Pixantrone, a novel aza-anthracenedione with structural similarities to mitoxantrone and anthracyclines, is theorized to exhibit less cardiotoxicity, mainly due to lack of iron binding. We conducted a randomized phase II study to evaluate the efficacy and safety of 2 dosing schedules of pixantrone in patients with refractory HER2-negative MBC.MethodsIntravenous pixantrone was administered at 180 mg/m² every 3 weeks (group A) versus 85 mg/m² on days 1, 8, and 15 of a 28-day cycle (group B). Primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), median 6-month PFS, overall survival (OS), safety, quality of life, and serial assessment of circulating tumor cells. A 20% ORR was targeted as sufficient for further testing of pixantrone in this patient population.ResultsForty-five patients were evaluable, with 2 confirmed partial responses in group A and 1 in group B. The trial was terminated due to insufficient activity. Overall median PFS and OS were 2.8 (95% confidence interval [CI]: 2.0-4.1) and 16.8 (95% CI: 8.9-21.6) months, respectively. Notable overall grade 3-4 adverse events were the following: neutrophil count decrease (62%), fatigue (16%), and decrease in ejection fraction (EF) (4%).ConclusionPixantrone has insufficient activity in the second- and third-line MBC setting. It appears, however, to have limited cardiotoxicity. (ClinicalTrials.gov ID: {"type":"clinical-trial","attrs":{"text":"NCT01086605","term_id":"NCT01086605"}}NCT01086605).