Rationale and design for an investigation to optimize selective serotonin reuptake inhibitor treatment for pregnant women with depression.

The physiological changes of pregnancy can affect the pharmacokinetics of a drug, thereby affecting its dose requirements. Because pharmacokinetic (PK) studies in pregnant women have rarely been conducted, evidence-based dosing adjustments are seldom available. In particular, despite the fact that the use of antidepressants has become increasingly common, pregnancy-associated PK changes of the selective serotonin reuptake inhibitors (SSRIs) are largely unknown.

A randomized trial of misoprostol versus extra-amniotic sodium chloride infusion with oxytocin for induction of labor.

OBJECTIVE: Our purpose was to compare the efficacy and safety of misoprostol and extra-amniotic sodium chloride infusion with oxytocin for induction of labor. STUDY DESIGN: This randomized trial compared two methods of labor induction in women requiring cervical ripening. One hundred twenty-three women undergoing labor induction with a Bishop score < or =5 were randomly selected to receive either misoprostol, 50 microg intravaginally every 4 hours, or extra-amniotic sodium chloride infusion. The primary outcome variable was the time interval from induction to vaginal delivery. RESULTS: Sixty-one women received extra-amniotic sodium chloride infusion and 62 women received misoprostol. The mean time interval from the start of induction to vaginal delivery was 15.0 +/- 5.0 hours and 16.5 +/- 7.2 hours for the extra-amniotic infusion and misoprostol groups, respectively (P, not significant). The cesarean delivery rate was not significantly different between the 2 groups (32.8% for the extra-amniotic infusion group; 19.4% for the misoprostol group). Maternal and neonatal outcomes were similar between the 2 groups. CONCLUSIONS: Both methods of induction are equally efficacious and result in similar maternal and neonatal outcomes.

Placenta previa: a 22-year analysis.

OBJECTIVE: Our purpose was to identify what anesthetic method is safer for women with a placenta previa. STUDY DESIGN: We retrospectively reviewed all women with placenta previa who underwent cesarean delivery during the period January 1, 1976-December 31, 1997 at Northwestern Memorial Hospital. RESULTS: Of 93,384 deliveries, placenta previa was found in 514 women. Identifiable trends with time included an increasing incidence of placenta previa (r = 0.54, P <.01); cesarean hysterectomy (r = 0.54, P <.01); placenta accreta (r = 0.45, P <.03); and regional anesthesia (r = 0.84, P <.0001). The mean gestational age at delivery was 35.3 +/- 3.4 weeks and did not change with time. General anesthesia was used for delivery in 380 women and regional anesthesia was used for 134 women. Prior cesarean delivery and general anesthesia were independent predictors of the need for blood transfusion, but only prior cesarean delivery was a predictor of the need for hysterectomy. General anesthesia increased the estimated blood loss, was associated with a lower postoperative hemoglobin concentration, and increased the need for blood transfusion. Elective and emergent deliveries did not differ in estimated blood loss, in postoperative hemoglobin concentrations, or in the incidence of intraoperative and anesthesia complications. Regional and general anesthesia did not differ in the incidence of intraoperative and anesthesia complications. CONCLUSIONS: In women with placenta previa, general anesthesia increased intraoperative blood loss and the need for blood transfusion. Regional anesthesia appears to be a safe alternative.

Generics: what's in a name?

Historically, the most common intervention performed by physicians has been the writing of a prescription. Often the prescription was a combination of active agents and an inactive base. This art is no longer practiced in the United States. Currently, most prescriptions are written for specific "drugs." As the prescription is being written, the physician must decide to administer a brand-name or a generic equivalent. Generics are a class of medications prescribed for reasons of economy, and the physician and the patient expect that the therapeutic effect will be exactly the same as for the brand-name. Bioequivalence of specific agents can be assessed using the FDA's Orange Book. In addition to bioequivalence, many other scientific, ethical, and economic issues should be considered before a decision is made. Prescribing vigilance is necessary, because in many instances available information is often controlling or insufficient to support rational decisions. Brand-names, rather than generics, should be selected when the therapeutic index is narrow or if the likelihood of generic switching is high. The paper will discuss all aspects of the subject.

Single-dose methotrexate for the treatment of ectopic pregnancy: Northwestern Memorial Hospital three-year experience.

OBJECTIVE: Our purpose was to evaluate the effectiveness of single-dose intramuscular methotrexate in the treatment of ectopic pregnancies by physicians in the Department of Obstetrics and Gynecology of Northwestern Memorial Hospital and to compare the results with those of previously published studies. STUDY DESIGN: A retrospective chart review was performed of 50 patients with ectopic pregnancies treated with single-dose methotrexate according to the protocol of Stovall et al. from January 1992 to February 1995. RESULTS: The mean pretreatment level of beta-human chorionic gonadotropin was 1896.4 +/- 2399 mlU/ml. Only 32 women (64%) were successfully treated with a single dose of methotrexate. An additional 7 women required a second or third injection. The combined success rate for medical management of ectopic pregnancy with one to three doses of methotrexate was 78% (39 women). Pretreatment beta-human chorionic gonadotropin levels were significantly lower in women who responded to single-dose therapy than in those who required either two or three doses or who had failure of medical management (p = 0.0011). The mean time to resolution of beta-human chorionic gonadotropin was 26.5 +/- 17 days. Higher pretreatment levels correlated with longer resolution time (r = 0.83, p < 0.001). Eleven women (22%) with failure of medical management required surgery. CONCLUSIONS: In our series single-dose methotrexate was only 64% successful. Women with a pretreatment beta-human chorionic gonadotropin level >5000 mlU/ml had a greater probability of requiring either surgical intervention or multiple doses of methotrexate. The potential for emergency surgery remains an important risk.