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Relatively few drugs, especially those recently approved by the US Food and Drug Administration, have published human pregnancy experience. Although all drugs contain animal reproduction data, these are usually not predictive of human risk. Clinical trials in pregnant women are rarely conducted because of ethical and legal concerns, and it may be many years before sufficient observational data are collected to guide clinical treatment decisions. Because many of these drugs will be used in pregnancy, human data are needed shortly after the drugs come to the market. Lack of human data leads to uncertainty over whether a drug can be safely prescribed for a pregnant patient. Unless there are compelling scientific and ethical reasons to exclude them, pregnant women should be included in phase IV clinical trials (postmarketing studies to obtain additional information, including the risks, benefits, and optimal use of a drug). This paper examines how physicians currently counsel pregnant women when there are no human data and proposes an alternative method in which knowledge regarding risks associated with the use of drugs during pregnancy can be enhanced in a clinical trial setting. [ABSTRACT FROM AUTHOR]

Background: Women with bipolar disorder (BD) are at high risk for postpartum affective episodes and psychosis. Although validated screening tools are available for postpartum unipolar depression, few screening tools for hypomania/mania exist. Screening tools for BD in the postpartum period are essential for improving detection and planning appropriate treatment. We evaluated whether adding the Mood Disorders Questionnaire (MDQ) to the Edinburgh Postnatal Depression Scale (EPDS) increased the identification of BD in the early postpartum period. Methods: Women (N = 1,279) who delivered a live infant and screened positive on the EPDS and/or MDQ at 4-6 weeks postbirth were invited to undergo an in-home Structured Clinical Interview for DSM-IV (SCID). Results: Positive EPDS and/or MDQ screens occurred in 12% of the sample (n = 155). In home SCID diagnostic interviews were completed in 93 (60%) of the mothers with positive screens. BD was the primary diagnosis in 37% (n = 34). Women with BD screened positive on the EPDS and/or MDQ as follows: EPDS+/MDQ+ (n = 14), EPDS+/MDQ- (n = 17), and EPDS-/MDQ+ (n = 3). The MDQ identified 50% (17/34) of the women with BD and 6 additional cases of BD when the MDQ question regarding how impaired the mother perceived herself was excluded from the screen criterion. Conclusion: Addition of the MDQ to the EPDS improved the distinction of unipolar depression from bipolar depression at the level of screening in 50% of women with traditional MDQ scoring and by nearly 70% when the MDQ was scored without the impairment criterion. [ABSTRACT FROM AUTHOR]

Disengagement of emotion regulation circuits was previously shown in depressed mothers and was hypothesized to underlie the impaired maternal–infant sensitivity described in postpartum depression (PPD). We hypothesized similarly reduced resting-state functional connectivity in default mode network (DMN) regions involved in social cognition in PPD. Resting-state functional MRI, clinical and mother–infant attachment data were obtained from 14 unmedicated postpartum women with major depression and 23 healthy postpartum women. Posterior cingulate cortex (PCC) time series were extracted, filtered between 0.007 and 0.08 Hz and used as regressors in a whole brain general linear model analysis. PCC–right amygdala connectivity was significantly disrupted in depressed compared to healthy mothers for low-frequency neural activity, showing a negative (inverse) coupling in the depressed group but not in the controls. PCC–right amygdala connectivity was positively correlated with PCC–parahippocampus connectivity. Resting connectivity patterns of positive co-activations in postpartum women mirrored the canonical DMN. These findings of reduced PCC–amygdala coupling raise the possibility that PPD might involve the disruption of outward, preventative aspects of self-relevant thought and theory of mind/empathy processes. Further integrated studies of neural connectivity and these cognitive/behavioral dimensions are warranted. [ABSTRACT FROM PUBLISHER]

Objective Gestational diabetes mellitus ( GDM) affects 7% of pregnant mothers, and those with GDM have increased rates of perinatal complications. Major depressive disorder ( MDD) and its pharmacologic treatments are associated with obesity and adverse pregnancy outcomes. In this prospective study, we investigated the relationship between abnormal GDM screens, maternal mood disorders, and adverse outcomes. Methods We examined mothers with MDD, those with bipolar disorder ( BD), and healthy controls ( HC) at 20, 30, and 36 weeks of gestation and delivery. We obtained demographic data and pre-pregnancy body mass index ( BMI), and confirmed diagnoses with the Structured Clinical Interview for DSM- IV. We evaluated smoking, alcohol use, substance use, and medication treatments with the Longitudinal Interval Follow-up Evaluation interview. Mothers received the one-hour 50-g glucose challenge test ( GCT) at 26-28 weeks of gestation. Outcome variables were preterm birth, birth weight ( BW) and peripartum events. Results We enrolled 62 HC, 50 BD, 41 past MDD, and 39 current MDD mother-infant pairs. Mean GCT levels and the frequency of abnormal GCT (>140 mg/ dL) did not differ across groups. Rates of smoking (χ2 = 20.68, df = 3, p < 0.001), substance use (χ2 = 21.76, df = 3, p < 0.001), and pre-pregnancy obesity [BMI ≥ 30 (χ2 = 9.97, df = 3, p = 0.019)] differed significantly across groups. Mothers with BD received medications associated with weight gain significantly more often than others [13/45 (29%), p < 0.001). After adjusting for group differences, GCT levels were associated significantly with increased odds for preterm birth (odds ratio = 1.29, 95% confidence interval: 1.0-1.7, p = 0.05) and increased perinatal events (beta = 0.11, p = 0.04) but were not associated with BW. Conclusions In mothers with or without mood disorders, having increased GCT levels contributes to a higher likelihood for adverse pregnancy outcomes. Mothers with BD or current MDD can have additional risks for adverse outcomes and may benefit from early referral for high-risk services and supportive management in pregnancy. [ABSTRACT FROM AUTHOR]