Postpartum Bleeding in Pregnant Women Receiving SSRIs/SNRIs: New Insights From a Descriptive Observational Study and an Analysis of Data from the FAERS Database

Perrotta, Cristiana; Giordano, Francesca; Colombo, Anna; Carnovale, Carla; Castiglioni, Michele; Bernardo, Ilaria Di; Giorgetti, Federica; Pileri, Paolo; Clementi, Emilio; Viganò, Caterina

doi:10.1016/j.clinthera.2019.06.008

Cited by 13 publications

(13 citation statements)

References 43 publications

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“…The difference in blood loss between the two subgroups was confirmed in case of vaginal delivery (p = 0.020), while no significant difference was observed in case of caesarean section (p = 0.257). This result confirms a previous result from a sample of 43 women whose plasma concentration was available at delivery (Perrotta et al, 2019).…”

Section: Neonatal and Maternal Outcomessupporting

confidence: 92%

Correlation between pharmacokinetics and pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Selective Serotonin and Noradrenaline Reuptake Inhibitors and maternal and neonatal outcomes: Results from a naturalistic study in patients with affective disorders

Colombo

Giordano

Giorgetti

et al. 2020

Human Psychopharmacology

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Objective: Some studies have linked the use of selective serotonin reuptake inhibitors and selective serotonin and noradrenaline reuptake inhibitors (SSRIs/ SNRIs) to the risk of perinatal complications. This study explored the relationship between pharmacokinetics and pharmacogenetics, SSRIs/SNRIs tolerability and effectiveness and maternal and newborn outcomes.Methods: Fifty-five pregnant women with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses of affective disorders, treated with SSRIs/SNRIs, were recruited and, during the third trimester, their blood samples were collected for pharmacokinetic and pharmacogenetic analyses. Plasma levels and metabolic phenotypes were then related to different obstetrical and maternal outcomes. Results:The pharmacokinetic data were more stable for Sertraline, Citalopram, and Escitalopram compared to other molecules (p = 0.009). The occurrence of postnatal adaptation syndrome onset was associated with higher plasma levels for Sertraline (median at delivery: 16.7 vs. 10.5 ng/ml), but not for fluoxetine and venlafaxine.Finally, the subgroup within range plasma concentrations had less blood loss than the below range subgroup (p = 0.030).Conclusions: Plasma levels of Sertraline, Citalopram and Escitalopram were more frequently in range in late pregnancy when compared to other drugs. Drug plasma concentrations do not strictly correlate with worse perinatal outcomes, but with possible differences between the different drugs.

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Section: Neonatal and Maternal Outcomessupporting

confidence: 92%

Correlation between pharmacokinetics and pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Selective Serotonin and Noradrenaline Reuptake Inhibitors and maternal and neonatal outcomes: Results from a naturalistic study in patients with affective disorders

Colombo

Giordano

Giorgetti

et al. 2020

Human Psychopharmacology

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“…52 Furthermore, a recent study of serum levels of antidepressant medication in pregnant women found that women with levels below therapeutic thresholds experienced more PPH than those with levels in a therapeutic range. 51 The data used for the present study did not detail treated versus untreated depression, and the results showed an association between depression and PPH only for women in the longer or more complicated labor phenotypes. The possibility that depression is associated with other unmeasured comorbidities, which influence labor complexity and PPH, therefore remains a possibility.…”

Section: Discussionmentioning

confidence: 73%

“…These competing physiologic effects may explain why both treated and untreated depression in pregnancy have been associated with a risk for PPH 52 . Furthermore, a recent study of serum levels of antidepressant medication in pregnant women found that women with levels below therapeutic thresholds experienced more PPH than those with levels in a therapeutic range 51 . The data used for the present study did not detail treated versus untreated depression, and the results showed an association between depression and PPH only for women in the longer or more complicated labor phenotypes.…”

Section: Discussionmentioning

confidence: 99%

“…48 However, other authors have reported a positive influence of serotonin on myometrial contractility, possibly helping avoid uterine atony. 50,51 These competing physiologic effects may explain why both treated and untreated depression in pregnancy have been associated with a risk for PPH. 52 Furthermore, a recent study of serum levels of antidepressant medication in pregnant women found that women with levels below therapeutic thresholds experienced more PPH than those with levels in a therapeutic range.…”

Section: Discussionmentioning

confidence: 99%

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Predicting Postpartum Hemorrhage After Vaginal Birth by Labor Phenotype

Erickson

Lee

Carlson

2020

J Midwife Womens Health

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Introduction: Postpartum hemorrhage (PPH) is an important contributor to maternal morbidity and mortality. Predicting which laboring women are likely to have a PPH is an active area of research and a component of quality improvement bundles. The purpose of this study was to identify phenotypes of labor processes (ie, labors that have similar features, such as duration and type of interventions) in a cohort of women who had vaginal births, estimate the likelihood of PPH by phenotype, and analyze how maternal and fetal characteristics relate to PPH risk by phenotype. Methods: This study utilized the Consortium for Safe Labor dataset (2002-2008) and examined term, singleton, vaginal births. Using 16 variables describing the labor and birth processes, a latent class analysis was performed to describe distinct labor process phenotypes. Results: Of 24,729 births, 1167 (4.72%) women experienced PPH. Five phenotypes best fit the data, reflecting labor interventions, duration, and complications. Women who had shorter duration of admission after spontaneous labor onset (admitted in latent or active labor) had the lowest rate of PPH (3.8%-3.9%). The 2 phenotypes of labor progress characterized by women who had complicated prolonged labors (spontaneous or induced) had the highest rate of PPH (8.0% and 12.0%, respectively). However, the majority of PPH (n = 881, 75%) occurred in the phenotypes with fewer complications. Prepregnancy body mass index did not predict PPH. Overall, the odds of PPH were highest among nulliparous women (odds ratio [OR], 1.52; 95% CI, 1.30-1.77), as well as Black women (OR, 1.39; 95% CI, 1.13-1.73) and Hispanic women (OR, 1.85; 95% CI, 1.56-2.20). Within phenotypes, maternal race and ethnicity, nulliparity, macrosomia, hypertension, and depression were associated with increased odds of PPH. Discussion: Women who were classified into a lower-risk labor phenotype and still experienced PPH were more likely to be nulliparous, a person of color, or diagnosed with hypertension.

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“…Alternatively, spontaneous reporting systems represent a valuable source of information in frail populations, such as pregnant women. Despite the intrinsic limitations, data-mining of adverse drug reaction (ADR) reports allow to obtain real word data about the safety/efficacy profile of specific drugs, to compare therapeutic options, and gain insight on potential mechanisms of ADRs (Gentili et al, 2018;Perrotta et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

et al. 2021

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The published experience with biologics in childbearing age with autoimmune and inflammatory diseases mainly deals with the use of TNFα inhibitors (TNFα-i). Limited data are available for biologics targeting other cytokines or immunocompetent cells, especially for the inflammasome targeted therapy including IL-1 inhibitors and colchicine. We conducted a nested case-control study by using the US Food and Drug Administration Adverse Event Reporting System database aimed at quantifying the association between the use of IL-1 inhibitors/colchicine in pregnant women and the occurrence of maternal/fetal adverse effects. The reporting odds ratio was used as a measure of disproportional reporting. From the total cohort (40,033 pregnant women), we retrieved 7,620 reports related to neonatal AEs, 2,889 to fetal disorders, 8,364 to abortion, 8,787 to congenital disorders, and 7,937 to labor/delivery complications. Inflammasome-targeted drugs did not present any disproportionate reporting for all these clusters of AEs. TNFα-i confirmed their safety during pregnancy with aROR < 1 for all clusters of AEs except for labor complications. Finally, we performed a systematic review of the current literature. Data from the eligible studies (12 observational studies and 6 case reports; yielding a total of 2,075 patients) were reassuring. We found no major safety issues on malformations risk of inflammasome targeted therapies in pregnancy. However, due to limited data, the routine use of these agents should be considered in pregnancy only if risk benefit assessment justifies the potential risk to the fetus.

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Postpartum Bleeding in Pregnant Women Receiving SSRIs/SNRIs: New Insights From a Descriptive Observational Study and an Analysis of Data from the FAERS Database

Cited by 13 publications

References 43 publications

Correlation between pharmacokinetics and pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Selective Serotonin and Noradrenaline Reuptake Inhibitors and maternal and neonatal outcomes: Results from a naturalistic study in patients with affective disorders

Correlation between pharmacokinetics and pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Selective Serotonin and Noradrenaline Reuptake Inhibitors and maternal and neonatal outcomes: Results from a naturalistic study in patients with affective disorders

Predicting Postpartum Hemorrhage After Vaginal Birth by Labor Phenotype

Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

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