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1.
Am J Obstet Gynecol ; 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38710264

RESUMO

BACKGROUND: Postpartum hemorrhage is difficult to predict, is associated with significant maternal morbidity, and is the leading cause of maternal mortality worldwide. The identification of maternal biomarkers that can predict increased postpartum hemorrhage risk would enhance clinical care and may uncover mechanisms that lead to postpartum hemorrhage. OBJECTIVE: This retrospective case-control study employed agnostic proteomic profiling of maternal plasma samples to identify differentially abundant proteins in controls and postpartum hemorrhage cases. STUDY DESIGN: Maternal plasma samples were procured from a cohort of >60,000 participants in a single institution's perinatal repository. Postpartum hemorrhage was defined as a decrease in hematocrit of ≥10% or receipt of transfusion within 24 hours after delivery. Postpartum hemorrhage cases (n=30) were matched by maternal age and delivery mode (vaginal or cesarean) with controls (n=56). Mass spectrometry was used to identify differentially abundant proteins using integrated peptide peak areas. Statistically significant differences between groups were defined as P<.05 after controlling for multiple comparisons. RESULTS: By study design, cases and controls did not differ in race, ethnicity, gestational age at delivery, blood type, or predelivery platelet count. Cases had slightly but significantly lower predelivery and postdelivery hematocrit and hemoglobin. Mass spectrometry detected 1140 proteins, including 77 proteins for which relative abundance differed significantly between cases and controls (fold change >1.15, P<.05). Of these differentially abundant plasma proteins, most had likely liver or placental origins. Gene ontology term analysis mapped to protein clusters involved in responses to wound healing, stress response, and host immune defense. Significantly differentially abundant proteins with the highest fold change (prostaglandin D2 synthase, periostin, and several serine protease inhibitors) did not correlate with predelivery hematocrit or hemoglobin but identified postpartum hemorrhage cases with logistic regression modeling revealing good-to-excellent area under the operator receiver characteristic curves (0.802-0.874). Incorporating predelivery hemoglobin with these candidate proteins further improved the identification of postpartum hemorrhage cases. CONCLUSION: Agnostic analysis of maternal plasma samples identified differentially abundant proteins in controls and postpartum hemorrhage cases. Several of these proteins are known to participate in biologically plausible pathways for postpartum hemorrhage risk and have potential value for predicting postpartum hemorrhage. These findings identify candidate protein biomarkers for future validation and mechanistic studies.

2.
Clin Appl Thromb Hemost ; 30: 10760296241247203, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38619922

RESUMO

Venous thromboembolism (VTE) is a leading cause of maternal mortality. Obesity and cesarean delivery are established risk factors for pregnancy-related VTE. We identified additional risk factors among patients with obesity who underwent a cesarean delivery to identify those who need VTE prophylaxis. We conducted a secondary analysis of data from the Maternal-Fetal Medicine Units Network (MFMU) Cesarean Registry Database using a case-control design. Cases were identified as women with obesity having a pre-pregnancy body mass index of >30 kg/m2, who underwent cesarean delivery and subsequently developed deep venous thrombosis (DVT) or pulmonary embolism (PE). These women were compared to a control group of women with obesity who underwent cesarean delivery but did not develop DVT or PE. Analysis of risk factors associated with VTE was performed using Chi-Square test and Fisher's exact test. We identified 43 VTE cases and 172 controls in the MFMU database. Increased risk of VTE was noted in women with endometritis (OR of 4.58 [95% CI: 1.86-11.2, P = .0004]), receiving a blood transfusion (OR 17.07 [95% CI: 4.46-65.3, P = .0001]), having a coagulopathy (OR 27.73 [95% CI: 3.24-237.25, P = .0003]), and urinary tract infection (OR 2.39 [95% CI: 1.08-5.28, P = .03]). Important risk factors for VTE in women with obesity who undergo cesarean delivery include endometritis, intra- or post-operative transfusion, coagulopathy, and urinary tract infection. The presence of one or more of these factors may help guide provider decision-making regarding whether to administer thromboprophylaxis.


Assuntos
Endometrite , Embolia Pulmonar , Infecções Urinárias , Tromboembolia Venosa , Gravidez , Humanos , Feminino , Tromboembolia Venosa/prevenção & controle , Anticoagulantes/uso terapêutico , Endometrite/induzido quimicamente , Endometrite/complicações , Endometrite/tratamento farmacológico , Embolia Pulmonar/etiologia , Fatores de Risco , Obesidade/complicações , Obesidade/tratamento farmacológico , Infecções Urinárias/induzido quimicamente , Infecções Urinárias/complicações , Infecções Urinárias/tratamento farmacológico
4.
Am J Perinatol ; 2024 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-38290553

RESUMO

Our findings suggest that treating antepartum anemia with currently available iron therapies would result in significant cost-savings and reductions in adverse outcomes associated with anemia in this context. Ferric carboxymaltose likely confers the greatest overall benefit among competing options. This conclusion is robust to uncertainty, even when the cost these therapies is significantly higher than is demonstrated in the literature.

5.
Perfusion ; : 2676591241226465, 2024 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-38231793

RESUMO

BACKGROUND: The decision regarding intraoperative transfusion has traditionally been based on hemodynamic instability and estimated blood loss. We performed a systematic review to determine the validity of the oximetry method compared to standard of care for hemoglobin measurement. METHODS: A systematic literature review was conducted, and several libraries were searched from inception to March 31,2023. The primary outcome was comparing the mean difference between laboratory-derived hemoglobin and non-invasive, point-of-care hemoglobin measurement. Subgroup analysis included comparing the mean difference in the pediatric population and among female patients. RESULTS: A total of 276 studies were identified, and 37 were included. We found that the pooled mean difference varied qualitatively between adult and pediatric population (p value for heterogeneity <0.001). In adult populations, lab hemoglobin measurements were on average slightly higher than non-invasive measurements (mean difference = 0.23; 95% CI -0.13, 0.59), though there was greater heterogeneity across studies (I2 = 97%, p value = <0.001). In the pediatric population, most studies showed lab hemoglobin to be slightly lower (mean difference = -0.42; 95% CI -0.87 to 0.03). CONCLUSIONS: In general, there was no clinically significant difference in mean hemoglobin among adult and pediatric populations. The percentage of female participants had no effect on the mean difference in hemoglobin.

6.
Clin Pharmacokinet ; 63(1): 69-78, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37962827

RESUMO

BACKGROUND AND OBJECTIVE: Physiologically based pharmacokinetic (PBPK) models for pregnant women have recently been successfully used to predict maternal and umbilical cord pharmacokinetics (PK). Because there is very limited opportunity for conducting clinical and PK investigations for fetal drug exposure, PBPK models may provide further insights. The objectives of this study were to extend a whole-body pregnancy PBPK model by multiple compartments representing fetal organs, and to predict the PK of cefuroxime in the maternal and fetal plasma, the amniotic fluid, and several fetal organs. METHODS: To this end, a previously developed pregnancy PBPK model for cefuroxime was updated using the open-source software Open Systems Pharmacology (PK-Sim®/MoBi®). Multiple compartments were implemented to represent fetal organs including brain, heart, liver, lungs, kidneys, the gastrointestinal tract (GI), muscles, and fat tissue, as well as another compartment lumping organs and tissues not explicitly represented. RESULTS: This novel PBPK model successfully predicted cefuroxime concentrations in maternal blood, umbilical cord, amniotic fluid, and several fetal organs including heart, liver, and lungs. Further model validation with additional clinical PK data is needed to build confidence in the model. CONCLUSIONS: Being developed with an open-source software, the presented generic model can be freely re-used and tailored to address specific questions at hand, e.g., to assist the design of clinical studies in the context of drug research or to predict fetal organ concentrations of chemicals in the context of fetal health risk assessment.


Assuntos
Cefuroxima , Modelos Biológicos , Humanos , Gravidez , Feminino , Software , Líquido Amniótico , Músculos
7.
Arthritis Rheumatol ; 76(3): 411-420, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37947364

RESUMO

OBJECTIVE: This prospective study of pregnant patients, Surveillance To Prevent AV Block Likely to Occur Quickly (STOP BLOQ), addresses the impact of anti-SSA/Ro titers and utility of ambulatory monitoring in the detection of fetal second-degree atrioventricular block (AVB). METHODS: Women with anti-SSA/Ro autoantibodies by commercial testing were stratified into high and low anti-52-kD and/or 60-kD SSA/Ro titers applying at-risk thresholds defined by previous evaluation of AVB pregnancies. The high-titer group performed fetal heart rate and rhythm monitoring (FHRM) thrice daily and weekly/biweekly echocardiography from 17-26 weeks. Abnormal FHRM prompted urgent echocardiography to identify AVB. RESULTS: Anti-52-kD and/or 60-kD SSA/Ro met thresholds for monitoring in 261 of 413 participants (63%); for those, AVB frequency was 3.8%. No cases occurred with low titers. The incidence of AVB increased with higher levels, reaching 7.7% for those in the top quartile for anti-60-kD SSA/Ro, which increased to 27.3% in those with a previous child who had AVB. Based on levels from 15 participants with paired samples from both an AVB and a non-AVB pregnancy, healthy pregnancies were not explained by decreased titers. FHRM was considered abnormal in 45 of 30,920 recordings, 10 confirmed AVB by urgent echocardiogram, 7 being second-degree AVB, all <12 hours from normal FHRM and within another 0.75 to 4 hours to echocardiogram. The one participant with second/third-degree and two participants with third-degree AVB were diagnosed by urgent echocardiogram >17 to 72 hours from an FHRM. Surveillance echocardiograms detected no AVB when the preceding interval FHRM recordings were normal. CONCLUSION: High-titer antibodies are associated with an increased incidence of AVB. Anti-SSA/Ro titers remain stable over time and do not explain the discordant recurrence rates, suggesting that other factors are required. Fetal heart rate and rhythm (FHRM) with results confirmed by a pediatric cardiologist reliably detects conduction abnormalities, which may reduce the need for serial echocardiograms.


Assuntos
Bloqueio Atrioventricular , Complicações na Gravidez , Criança , Gravidez , Humanos , Feminino , Bloqueio Atrioventricular/diagnóstico , Bloqueio Atrioventricular/epidemiologia , Autoanticorpos , Estudos Prospectivos , Anticorpos Antinucleares , Ecocardiografia/métodos
8.
Sci Rep ; 13(1): 11998, 2023 07 25.
Artigo em Inglês | MEDLINE | ID: mdl-37491437

RESUMO

We aimed to evaluate the association between obesity and postpartum hemorrhage (PPH) after cesarean delivery (CD). This was a retrospective cohort study using a multicenter database of 20 hospitals in the United States. We analyzed 27,708 patients undergoing CD from 2015 to 2019. The exposure of interest was BMI, and the primary outcome was PPH (estimated blood loss [EBL] ≥ 1000 mL). Simple logistic regression was used to evaluate the relationship between obesity and intrapartum complications. Multivariable logistic regression was used to adjust for any confounding demographic variables. Hosmer and Lemeshow's purposeful selection algorithm was adapted to develop a multivariable logistic regression model of PPH. Analyses were conducted using STATA 16.1 (College Station, Texas) with p ≤ 0.05 considered significant. BMI exerted a significant effect on the frequency of PPH (p = 0.004). Compared to patients with BMI 18.5-24.9 kg/m2, patients with BMI between 25 and 59.9 kg/m2 had an increased odds of PPH. The odds of PPH in patients with BMI > 60 kg/m2 was not increased compared to patients with BMI 18.5-24.9 kg/m2. Obesity was associated with a decreased odds of blood transfusion (aOR 0.73, 95% CI 0.55-0.97). In conclusion, higher BMI was associated with PPH yet a lower odds of transfusion after CD.


Assuntos
Hemorragia Pós-Parto , Gravidez , Feminino , Humanos , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/etiologia , Índice de Massa Corporal , Estudos Retrospectivos , Cesárea/efeitos adversos , Obesidade/complicações , Fatores de Risco
9.
J Clin Pharmacol ; 63 Suppl 1: S81-S95, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37317489

RESUMO

Following the 2021 World Health Organization's updated recommendations on the management of HIV infection, millions of people living with HIV are currently switched from efavirenz-based antiretroviral therapy to dolutegravir-based antiretroviral therapy. Pregnant individuals transitioning from efavirenz to dolutegravir might be at increased risk of insufficient viral suppression in the immediate postswitch period because both efavirenz- and pregnancy-related increases in hormone levels induce enzymes involved in dolutegravir metabolism, namely, cytochrome P450 3A4 and uridine 5'-diphospho-glucuronosyltransferase 1A1. This study aimed at developing physiologically based pharmacokinetic models to simulate the switch from efavirenz to dolutegravir in the late second and third trimester. To this end, the drug-drug interaction between efavirenz and the uridine 5'-diphospho-glucuronosyltransferase 1A1 substrates dolutegravir and raltegravir was first simulated in nonpregnant subjects. After successful validation, the physiologically based pharmacokinetic models were translated to pregnancy and dolutegravir pharmacokinetics following efavirenz discontinuation were predicted. Modeling results indicated that, at the end of the second trimester, both efavirenz concentrations and dolutegravir trough concentrations fell below respective pharmacokinetic target thresholds (defined as reported thresholds producing 90%-95% of the maximum effect) during the time interval from 9.75 to 11 days after dolutegravir initiation. At the end of the third trimester, this time interval spanned from 10.3 days to >4 weeks after dolutegravir initiation. These findings suggest that dolutegravir exposure in the immediate post-efavirenz switch period during pregnancy may be suboptimal, leading to HIV viremia and, potentially, resistance. The clinical implications of these findings remain to be substantiated by future studies.


Assuntos
Infecções por HIV , Feminino , Gravidez , Humanos , Infecções por HIV/tratamento farmacológico , Benzoxazinas , Interações Medicamentosas , Glucuronosiltransferase
10.
J Thromb Thrombolysis ; 56(1): 128-136, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37133702

RESUMO

Postpartum hemorrhage is a significant contributor to maternal mortality worldwide and in the United States. Tranexamic acid (TXA) has been shown to reduce PPH complications although it is not routinely recommended for use as prophylaxis to date. To estimate the cost-effectiveness of alternative risk-dictated strategies utilizing prophylactic tranexamic acid for the prevention of postpartum hemorrhage. We constructed a microsimulation-based Markov decision-analytic model estimating the cost-effectiveness of three alternative risk-dictated strategies for tranexamic acid prophylaxis versus the no prophylaxis in a cohort of 3.8 million pregnant women delivering in the United States. Each strategy differentially modified risk-specific hemorrhage probabilities by preliminary estimates of tranexamic acid's prophylactic efficacy. Outcome measures included incremental costs, quality-adjusted life-years, and outcomes averted. Costs and benefits were considered from the healthcare system and societal perspectives over a lifetime time horizon. All intervention strategies were dominant versus no prophylaxis, implying that they were simultaneously more effective and cost-saving. Prophylaxing delivering women irrespective of hemorrhage risk produced the most favorable results overall, with estimated cost savings greater than $690 million and up to 149,505 PPH cases, 2,933 hysterectomies, and 70 maternal deaths averted, per annual cohort. Threshold analysis suggested that tranexamic acid is likely to be cost-saving for health systems at costs below $190 per gram. Our findings suggest that routine prophylaxis with tranexamic acid would likely result in substantial cost-savings and reductions in adverse maternal outcomes in this context. This study is a cost-effectiveness analysis demonstrating cost-savings and reduction in adverse maternal outcomes with routine tranexamic acid as prophylaxis for post-partum hemorrhage.


Assuntos
Antifibrinolíticos , Hemorragia Pós-Parto , Ácido Tranexâmico , Feminino , Gravidez , Humanos , Estados Unidos/epidemiologia , Hemorragia Pós-Parto/prevenção & controle , Ácido Tranexâmico/uso terapêutico , Análise de Custo-Efetividade , Antifibrinolíticos/uso terapêutico , Probabilidade , Análise Custo-Benefício
11.
AJOG Glob Rep ; 3(2): 100195, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37180460

RESUMO

BACKGROUND: Newer research comparing routes of medication administration has extended beyond efficacy as a primary endpoint to incorporate patient preference. However, little is known about the preferences of pregnant women in terms of routes of medication administration, specifically with regards to hemorrhage prevention and control. OBJECTIVE: This study aimed to understand the preferences of pregnant women in terms of medical interventions to prevent hemorrhage at the time of delivery. STUDY DESIGN: Surveys were distributed from April 2022 to September 2022 using electronic tablets at a single urban center with an annual delivery volume of 3000 women per year to women >18 years of age who were either currently pregnant or have been pregnant in the past. Subjects were asked to choose their preferred route of administration from the following options: intravenous, intramuscular, or subcutaneous. The primary outcome was patient preference on the route of medication administration during a hemorrhage event. RESULTS: The study cohort included 300 patients, mostly African American (39.8%) followed by White (32.1%), and the majority of the participants ranged from 30 to 34 years of age (31.7%). When asked which method of administration they would prefer to prevent hemorrhage before birth, the results were as follows: 31.1% would prefer intravenous, 23.0% had no preference, 21.2% were unsure, 15.9% preferred subcutaneous, and 8.8% preferred intramuscular administration. In addition, 69.4% of respondents reported that they have never declined or avoided intramuscular administration of medication if recommended by their physician. CONCLUSION: Although some survey participants preferred an intravenous route of administration, 68.9% of subjects were unsure, had no preference, or preferred nonintravenous routes. This information is helpful particularly in low-resource settings where intravenous treatments are not readily available or in urgent clinical situations in which intravenous administration routes are not easily obtainable in high-risk patients.

12.
PLoS One ; 18(4): e0284333, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37075041

RESUMO

BACKGROUND: Oral contraceptive (OC) use increases venous thromboembolism risk 2-5-fold. Procoagulant changes can be detected in plasma from OC users even without thrombosis, but cellular mechanisms that provoke thrombosis have not been identified. Endothelial cell (EC) dysfunction is thought to initiate venous thromboembolism. It is unknown whether OC hormones provoke aberrant procoagulant activity in ECs. OBJECTIVE: Characterize the effect of high-risk OC hormones (ethinyl estradiol [EE] and drospirenone) on EC procoagulant activity and the potential interplay with nuclear estrogen receptors ERα and ERß and inflammatory processes. METHODS: Human umbilical vein and dermal microvascular ECs (HUVEC and HDMVEC, respectively) were treated with EE and/or drospirenone. Genes encoding the estrogen receptors ERα and ERß (ESR1 and ESR2, respectively) were overexpressed in HUVEC and HDMVEC via lentiviral vectors. EC gene expression was assessed by RT-qPCR. The ability of ECs to support thrombin generation and fibrin formation was measured by calibrated automated thrombography and spectrophotometry, respectively. RESULTS: Neither EE nor drospirenone, alone or together, changed expression of genes encoding anti- or procoagulant proteins (TFPI, THBD, F3), integrins (ITGAV, ITGB3), or fibrinolytic mediators (SERPINE1, PLAT). EE and/or drospirenone did not increase EC-supported thrombin generation or fibrin formation, either. Our analyses indicated a subset of individuals express ESR1 and ESR2 transcripts in human aortic ECs. However, overexpression of ESR1 and/or ESR2 in HUVEC and HDMVEC did not facilitate the ability of OC-treated ECs to support procoagulant activity, even in the presence of a pro-inflammatory stimulus. CONCLUSIONS: The OC hormones EE and drospirenone do not directly enhance thrombin generation potential of primary ECs in vitro.


Assuntos
Trombose , Tromboembolia Venosa , Feminino , Humanos , Anticoncepcionais Orais , Receptor alfa de Estrogênio , Receptores de Estrogênio , Trombina/farmacologia , Trombina/metabolismo , Receptor beta de Estrogênio , Etinilestradiol/farmacologia , Fibrina
13.
Expert Rev Hematol ; 16(sup1): 71-86, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36920864

RESUMO

BACKGROUND: People who have or had the potential to menstruate (PPM) with inherited bleeding disorders (BD) face particular challenges receiving appropriate diagnosis and care and participating in research. As part of an initiative to create a National Research Blueprint for future decades of research, the National Hemophilia Foundation (NHF) and American Thrombosis and Hemostasis Network conducted extensive all-stakeholder consultations to identify the priorities of PPM with inherited BDs and those who care for them. RESEARCH DESIGN AND METHODS: Working group (WG) 4 of the NHF State of the Science Research Summit distilled community-identified priorities for PPM with inherited BDs into concrete research questions and scored their feasibility, impact, and risk. RESULTS: WG4 identified important gaps in the foundational knowledge upon which to base optimal diagnosis and care for PPM with inherited BDs. They defined 44 top-priority research questions concerning lifespan sex biology, pregnancy and the post-partum context, uterine physiology and bleeding, bone and joint health, health care delivery, and patient-reported outcomes and quality-of-life. CONCLUSIONS: The needs of PPM will best be advanced with research designed across the spectrum of sex and gender biology, with methodologies and outcome measures tailored to this population, involving them throughout.


Up to 1% of cisgender women and girls have an inherited bleeding disorder (BD). Common symptoms include heavy menstrual bleeding (HMB), heavy bleeding after giving birth known as post-partum hemorrhage (PPH), nose bleeds, bleeding from the mouth, and excessive bleeding after surgery or procedures. They can also experience bleeding into their muscles, joints, and even into the brain. Uterine bleeding, such as from HMB and PPH, can impact the lives of anyone who has or had a uterus, a group we designate as people who have or had the potential to menstruate (PPM).Many PPM with an inherited BD do not receive diagnosis, treatment, and care needed due to a lack of expertise among health care professionals and the public, misunderstanding, and bias. Uncertainty about "normal" versus "abnormal" bleeding can contribute to a lack of diagnosis, treatment, and care. Language, such as the label of "carrier," can be a barrier to accessing treatment and care for PPM.People with inherited BDs, health care professionals with various expertise and focus, and researchers worked together to identify the research that would most improve the lives of PPM, in six focus areas where there are major gaps in knowledge and the lack of standards required for accurate diagnosis.


Assuntos
Doenças Hematológicas , Menstruação , Feminino , Humanos , Gravidez , Estados Unidos
14.
Am J Obstet Gynecol MFM ; 5(6): 100933, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36933804

RESUMO

BACKGROUND: Results from the 2017 World Maternal Antifibrinolytic trial found that patients who received tranexamic acid during delivery had significantly lower rates of death and hysterectomy. Several months after the World Maternal Antifibrinolytic trial publication, American College of Obstetricians and Gynecologists endorsed the consideration of tranexamic acid usage when traditional uterotonics fail during postpartum hemorrhage. Since then, tranexamic acid usage has become more mainstream for the treatment of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate tranexamic acid trends in obstetrics both temporally and geographically within the United States. Additional outcomes included patient demographics and perinatal outcomes. STUDY DESIGN: This retrospective cohort study included 19 hospitals divided into East, Central, and West geographic regions within the Universal Health Services, Incorporated network. Rates of tranexamic acid use were compared from July 2019 through June 2021. Patient demographics and perinatal outcomes were analyzed for tranexamic acid recipients. RESULTS: During the two-year study period, 3.2% (1580/50,150) of patients received tranexamic acid during delivery. The western region of the United States demonstrated increased tranexamic acid use over the 2-year study period. Recipients of tranexamic acid were more likely to have a history of postpartum hemorrhage (P<.0001), chronic hypertension (P<.0001), preeclampsia (P<.0001), and/or diabetes (P=.004). Patients who received tranexamic acid did not have an increased likelihood of venous thromboembolism in comparison with those who did not receive tranexamic acid (8 [0.5%] vs 226 [0.5%]; P=.77). Of those who received tranexamic acid, 53.2% (840/1580) had an estimated blood loss <1000 mL. CONCLUSION: Nationally, a higher percentage of patients received tranexamic acid without a postpartum hemorrhage diagnosis compared with previous studies, and the western region of the United States had an overall increased use of tranexamic acid during delivery compared with previous years. There was no increased risk of venous thromboembolism in those who received tranexamic acid, regardless of postpartum hemorrhage diagnosis.


Assuntos
Antifibrinolíticos , Hemorragia Pós-Parto , Ácido Tranexâmico , Tromboembolia Venosa , Feminino , Humanos , Gravidez , Antifibrinolíticos/efeitos adversos , Período Periparto , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/prevenção & controle , Estudos Retrospectivos , Ácido Tranexâmico/efeitos adversos , Estados Unidos/epidemiologia , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia
15.
J Thromb Thrombolysis ; 55(4): 742-746, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36826757

RESUMO

INTRODUCTION: Postpartum hemorrhage (PPH) was the second leading cause of maternal death, accounting for approximately 14% of all pregnancy-related deaths between 2017 and 2019 in the United States. Several large multi-center studies have demonstrated decreased PPH rates with the use of tranexamic acid (TXA). Little data exists regarding the prevalence of TXA use in obstetric patients. METHODS: We identified over 1.2 million US pregnancies between January 1, 2015 and June 30, 2021, with and without PPH by International Statistical Classification of Disease and Related Health Problems, Tenth Revision codes using Cerner Real-World Database™. TXA use and patient characteristics were abstracted from the electronic medical record. RESULTS: During delivery, TXA was used approximately 1% of the time (12,394 / 1,262,574). Pregnant patients who did and did not receive TXA during delivery had similar demographic characteristics. Pregnant patients who underwent cesarean delivery (4,356 / 12,394), had a term delivery (10,199 / 12,394), and had comorbid conditions were more likely to receive TXA during hospitalization for delivery. The majority of TXA was use was concentrated in Arizona, Colorado, Idaho, New Mexico, Nevada, Utah, and Wyoming. During the study period the use of TXA increased in both patients with PPH and those without. CONCLUSION: The data illustrate a rapid increase in the use of TXA after 2017 while the total number of pregnancies remained relatively constant. The observed increase in TXA use may reflect changing practicing patterns as the support for use of TXA in the setting of PPH prophylaxis increases.


Assuntos
Antifibrinolíticos , Hemorragia Pós-Parto , Ácido Tranexâmico , Gravidez , Feminino , Humanos , Estados Unidos/epidemiologia , Ácido Tranexâmico/uso terapêutico , Hemorragia Pós-Parto/tratamento farmacológico , Hemorragia Pós-Parto/epidemiologia , Antifibrinolíticos/uso terapêutico , Cesárea , Mortalidade Materna
16.
J Thromb Thrombolysis ; 55(3): 571-575, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36592298

RESUMO

Both thrombocytopenia (platelet count < 150 × 103/µL) and anemia have been associated with postpartum hemorrhage (PPH). However, the impact of thrombocytopenia on PPH risk among women with mild and severe anemia is unknown. We sought to evaluate the association between thrombocytopenia and anemia in increasing risk of PPH. We performed a secondary analysis of a retrospective cohort of pregnant women from 19 hospitals across the United States from 2016 to 2021. Women who had a term singleton pregnancy and hematocrit (Hct) ≤ 33% at delivery were included in the study. The primary outcome was PPH (defined as blood loss ≥ 1000 mL or blood transfusion). We also analyzed the effect of severe anemia (Hct < 28%) on the association between PPH and thrombocytopenia. Chi-squared tests and Fisher's exact tests were used for categorical variables and an independent t-test was used for continuous variables. There were 20,808 women who met our inclusion criteria, of which 1793 (8.6%) had platelet count < 150 × 103/µL. The prevalence of PPH was 6.4%. Compared with women with normal platelet count, those with thrombocytopenia had 1.3-fold higher odds of PPH [6.8% vs. 4.5%, adjusted OR 1.3 (1.1-1.7)]. Platelet count ≥ 150 × 103/µL was associated with decreased odds of PPH among patients with hct between 28 and 33% and hct < 28%. In conclusion, anemic women with term singleton pregnancies who delivered with thrombocytopenia had a higher frequency of PPH. Normal platelet count at delivery was protective against PPH in the setting of anemia regardless of severity.


Assuntos
Anemia , Hemorragia Pós-Parto , Trombocitopenia , Feminino , Gravidez , Humanos , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/etiologia , Estudos Retrospectivos , Trombocitopenia/complicações , Trombocitopenia/epidemiologia , Período Pós-Parto , Anemia/complicações , Anemia/epidemiologia , Fatores de Risco
17.
BMJ Glob Health ; 8(1)2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36646475

RESUMO

INTRODUCTION: Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies. METHODS: We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale. RESULTS: We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection-as compared with uninfected pregnant women-were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias. CONCLUSIONS: This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction. As more data become available, we will update these findings per the published protocol.


Assuntos
COVID-19 , Gestantes , Recém-Nascido , Gravidez , Feminino , Humanos , Estudos Prospectivos , SARS-CoV-2
18.
Br J Clin Pharmacol ; 89(2): 483-490, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-34904271

RESUMO

There is paucity of evidence to support clinical decision making and counselling related to medication use in pregnancy. Despite multiple efforts from legislative bodies and advocacy groups, the inclusion of pregnant women in clinical drug trials assessing efficacy and safety remains scarce. Pregnancy can be complicated by multiple comorbidities that require pharmacological intervention; these interventions primarily target the pregnant woman but also sometimes have secondary effects for the foetus. The US Food and Drug Administration has issued multiple guidance documents on incorporating pregnant women in clinical trials to aid pharmaceutical companies in designing a protocol to ensure safety and adherence to ethical standards. Advances in paediatric pharmacology studies provide lessons for researchers on the best practice of designing clinical trials with inclusion of patients from special populations. In this review, we present the status of pregnant women in clinical trials, highlighting the ethical stigma and possible future directives.


Assuntos
Complicações na Gravidez , Criança , Gravidez , Feminino , Humanos , Complicações na Gravidez/tratamento farmacológico , Gestantes , Tomada de Decisão Clínica
19.
Pediatr Res ; 93(5): 1276-1284, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36335267

RESUMO

BACKGROUND: Fetal growth restriction (FGR) is a risk factor for neurodevelopmental problems, yet remains poorly understood. We sought to examine the relationship between intrauterine development and neonatal neurobehavior in pregnancies diagnosed with antenatal FGR. METHODS: We recruited women with singleton pregnancies diagnosed with FGR and measured placental and fetal brain volumes using MRI. NICU Network Neurobehavioral Scale (NNNS) assessments were performed at term equivalent age. Associations between intrauterine volumes and neurobehavioral outcomes were assessed using generalized estimating equation models. RESULTS: We enrolled 44 women diagnosed with FGR who underwent fetal MRI and 28 infants underwent NNNS assessments. Placental volumes were associated with increased self-regulation and decreased excitability; total brain, brainstem, cortical and subcortical gray matter (SCGM) volumes were positively associated with higher self-regulation; SCGM also was positively associated with higher quality of movement; increasing cerebellar volumes were positively associated with attention, decreased lethargy, non-optimal reflexes and need for special handling; brainstem volumes also were associated with decreased lethargy and non-optimal reflexes; cerebral and cortical white matter volumes were positively associated with hypotonicity. CONCLUSION: Disrupted intrauterine growth in pregnancies complicated by antenatally diagnosed FGR is associated with altered neonatal neurobehavior. Further work to determine long-term neurodevelopmental impacts is warranted. IMPACT: Fetal growth restriction is a risk factor for adverse neurodevelopment, but remains difficult to accurately identify. Intrauterine brain volumes are associated with infant neurobehavior. The antenatal diagnosis of fetal growth restriction is a risk factor for abnormal infant neurobehavior.


Assuntos
Retardo do Crescimento Fetal , Placenta , Recém-Nascido , Lactente , Humanos , Gravidez , Feminino , Placenta/diagnóstico por imagem , Placentação , Letargia , Encéfalo/diagnóstico por imagem
20.
Am J Obstet Gynecol ; 228(2): 161-177, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36027953

RESUMO

OBJECTIVE: This sequential, prospective meta-analysis sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to disease severity, maternal morbidities, neonatal mortality and morbidity, and adverse birth outcomes. DATA SOURCES: We prospectively invited study investigators to join the sequential, prospective meta-analysis via professional research networks beginning in March 2020. STUDY ELIGIBILITY CRITERIA: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area. METHODS: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a 2-stage meta-analysis. RESULTS: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (preexisting diabetes mellitus, hypertension, cardiovascular disease) vs those without were at higher risk for COVID-19 severity and adverse pregnancy outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% confidence interval, 1.12-2.71) more likely to be admitted to the intensive care unit. Pregnant women who were underweight before pregnancy were at higher risk of intensive care unit admission (relative risk, 5.53; 95% confidence interval, 2.27-13.44), ventilation (relative risk, 9.36; 95% confidence interval, 3.87-22.63), and pregnancy-related death (relative risk, 14.10; 95% confidence interval, 2.83-70.36). Prepregnancy obesity was also a risk factor for severe COVID-19 outcomes including intensive care unit admission (relative risk, 1.81; 95% confidence interval, 1.26-2.60), ventilation (relative risk, 2.05; 95% confidence interval, 1.20-3.51), any critical care (relative risk, 1.89; 95% confidence interval, 1.28-2.77), and pneumonia (relative risk, 1.66; 95% confidence interval, 1.18-2.33). Anemic pregnant women with COVID-19 also had increased risk of intensive care unit admission (relative risk, 1.63; 95% confidence interval, 1.25-2.11) and death (relative risk, 2.36; 95% confidence interval, 1.15-4.81). CONCLUSION: We found that pregnant women with comorbidities including diabetes mellitus, hypertension, and cardiovascular disease were at increased risk for severe COVID-19-related outcomes, maternal morbidities, and adverse birth outcomes. We also identified several less commonly known risk factors, including HIV infection, prepregnancy underweight, and anemia. Although pregnant women are already considered a high-risk population, special priority for prevention and treatment should be given to pregnant women with these additional risk factors.


Assuntos
COVID-19 , Doenças Cardiovasculares , Infecções por HIV , Hipertensão , Complicações na Gravidez , Nascimento Prematuro , Gravidez , Recém-Nascido , Feminino , Humanos , COVID-19/epidemiologia , Nascimento Prematuro/epidemiologia , Estudos Prospectivos , Magreza , SARS-CoV-2 , Resultado da Gravidez/epidemiologia , Fatores de Risco , Complicações na Gravidez/epidemiologia , Período Pós-Parto
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