Reflections on the Canadian MORE(OB) obstetrical risk management programme.

In, 2001, the Patient Safety Division of the Society of Obstetricians and Gynaecologists of Canada initiated and championed a new program to improve patient safety performance in Canadian hospital obstetric units. This new program was developed under the banner of Managing Obstetrical Risk Efficiently and called the MORE(OB) Programme The MORE(OB) Programme was first piloted in Canadian hospitals at the beginning of May 2002 and, by mid 2004, 33 pilot sites had been implemented. In autumn 2004, this program embarked on a national launch. In 2007, the Society of Obstetricians and Gynaecologists of Canada collaborated with the Healthcare Insurance Reciprocal of Canada to form Salus Global Corporation. The birth of this corporate entity embraced the support of rapid expansion of the program within and outside of Canada. This collaboration also enabled innovation and implementation of safety programs beyond the obstetric discipline.

Patient safety in women's health-care: professional colleges can make a difference. The Society of Obstetricians and Gynaecologists of Canada MORE(OB) program.

The Society of Obstetricians and Gynaecologists of Canada has played a leadership role in advancing patient safety at the national level with the launching of their obstetric patient safety program 'Managing Obstetric Risks Efficiently' (MORE(OB)). Developed over a 2-year period and launched as a pilot in 2002, the program has extended to 126 hospitals in five provinces that provide care for 48% of the births in Canada. The end-point for the program is to change the culture of blame to a focused and sustained patient safety culture, where patient safety is everyone's responsibility, with observed reductions in events and improved quality of care. The program has integrated the principles of high reliability organizations (HROs), systems error theory, team function, and communities of practice (CoPs) as values for the work environment. In this chapter we describe how the program was developed, the role of the national specialty society in the development, and the funding, structure and implementation of the program, and we report on the impact of the program over the first 3 years. In these first 3 years, knowledge enhancement in all disciplines and in all practice environments, with a significant reduction in variance among the disciplines, has been demonstrated. Culture change has occurred in all practice settings and has continued to improve over time. Using liability claims information from the hospitals, a reduction trend has been observed in liability carrier (hospital) incurred costs.

Comparison of pharmacokinetics of a conjugated equine estrogen preparation (premarin) and a synthetic mixture of estrogens (C.E.S.) in postmenopausal women.

OBJECTIVE: To compare the pharmacokinetics and relative bioavailabilities of key estrogen components of Premarin (Wyeth-Ayerst, Canada) with those of a generic conjugated estrogen preparation, C.E.S. (synthetic mixture of estrogens; ICN, Montreal, Canada) in healthy postmenopausal women. METHODS: We conducted a randomized, single-dose, two-treatment, three-period crossover study in 41 postmenopausal women. After an oral dose (2 x 0.625 mg) of Premarin or C.E.S., plasma concentrations of unconjugated and total estrone (E(1)), equilin (Eq), 17beta-estradiol (17beta-E(2)), 17beta-dihydroequilin (17beta-Eq), Delta(8)-esterone (Delta(8)-E(1)) and Delta(8),17beta-estradiol (Delta(8),17beta-E(2)) were measured over 72 hours using gas chromatography and mass spectroscopy. RESULTS: After administration of C.E.S., E(1), Eq, and 17beta-Eq appeared in blood at a significantly faster rate (lower t(max)) than after Premarin. The rapid appearance of estrogens after C.E.S. was associated with significantly higher (14-61%) C(max) values. In contrast to the high C(max) values, the area under the curve (AUC)(infinity) of unconjugated and total Eq, and 17beta-Eq were significantly lower after C.E.S., whereas those of E(1) were significantly higher. Although, the t(max) values for 17beta-E(2) were lower and the C(max) values higher after C.E.S., only the C(max) of unconjugated 17beta-E(2) was significantly different after Premarin. Unconjugated and total Delta(8)-E(1) and its main metabolite, Delta(8),17beta-E(2), were detectable in plasma only after administration of Premarin. The geometric mean ratio (GMR) (C. E.S./Premarin) of bioavailability parameters indicated that all C(max) and t(max) values for the unconjugated and total E(1), Eq, 17beta-E(2), and 17beta-Eq fell outside the regulatory requirement that the 90% confidence intervals of GMRs of two products be within 80% and 125%. Similarly, with the exception of total E(1) and total Eq, none of the AUC(t) or AUC(alpha) of the remaining estrogens meets the required regulatory standards of bioequivalence. CONCLUSIONS: C.E.S. is not bioequivalent to Premarin. Because C.E.S. also is not pharmaceutically equivalent to Premarin, it cannot be assumed to be therapeutically equivalent. Until long-term clinical trials with C.E.S. demonstrate its efficacy, extrapolation of the long-term benefits described for Premarin to C.E.S. would be risky and questionable.

Management of premature rupture of membranes at term: randomized trial.

OBJECTIVE: We hypothesize that expectant management in the presence of premature rupture of membranes at term would result in a lower cesarean birth rate with no increase in maternal, fetal, or neonatal infection. STUDY DESIGN: Term patients who consented to the study were randomly allocated either to expectant management for 48 hours or to induction of labor 8 hours after premature rupture of membranes. Premature rupture of membranes was confirmed by sterile speculum examination of the vagina. Patients randomized to expectant management were transferred to antenatal care and were not examined vaginally until they went into labor. Patients randomized to induction of labor had induction with oxytocin 8 hours after premature rupture of membranes. RESULTS: Two hundred sixty-two patients were randomized to the expectant management and induction of labor groups. The cesarean birth rate and the clinical diagnosis of postpartum endometritis was not significantly different in the two groups. Pathologic diagnosis of chorioamnionitis and funisitis, however, was significantly greater in the expectant management group (p < 0.05). Eight of the 15 babies with funisitis were admitted to the neonatal intensive care unit for therapy (two in the induction of labor group and six in the expectant management group, p < 0.05). CONCLUSION: Expectant management did not reduce the incidence of cesarean birth and increased the pathologic diagnosis of funisitis and newborn requirements for neonatal intensive care.

An arteriovenous malformation in pregnancy: a case report and review of the literature.

A case is described of a young woman with progression of a macrofistulous arteriovenous malformation during pregnancy. This resulted in severe symptoms necessitating cesarean section, following which there was a dramatic postpartum recovery. The arteriovenous malformation was confirmed by angiography. The literature related to arteriovenous malformations in pregnancy is reviewed.

Isoenzymes of alkaline phosphatase in infantile hypophosphatasia.

Infantile hypophosphatasia is a rare inborn error of metabolism in which the expression of the liver/kidney/bone locus of the alkaline phosphatase gene is defective. Analysis of tissues from a suspected case of hypophosphatasia for alkaline phosphatase activity demonstrated very low levels of activity in liver, kidney, and rib as compared to tissues from a case of osteogenesis imperfecta or normal adult tissues. Intestinal and placental tissues demonstrated significant levels of activity. Gene-specific amino acid inhibitors and isoelectric focusing demonstrated that the activity which was present in the liver, kidney, and rib tissues from the case of hypophosphatasia was of the intestinal type and not the normal liver/kidney/bone form of the enzyme.

Spectral analysis as a diagnostic aid in the management of high-risk pregnancy.

Spectral analysis of the fetal heart rate and intrauterine pressure was done with data obtained during labor for 24 patients delivered of their infants in an obstetric intensive care unit. The patients were grouped according to clinical assessment of labor and neonatal outcome as normal (11), abnormal/premature (4), and prolonged labor/cesarean section (9). A comparison among groups of spectral density functions and of coherence functions and phase angles failed to reveal consistent features that could be used to distinguish between groups. However, an analysis of the variance (integrated spectrum) and the mean of the base-line component of the fetal heart rate showed that the values for the normal and abnormal/premature groups could be distinguished from the background population. It is suggested that a study of the joint statistics of the variance and the mean may lead to the development of a diagnostic aid to the early detection of incipient fetal distress.