Pregnancy Events Research Articles

Diagnostic value of sFlt-1/PlGF-1 ratio and plasma PROK1 for adverse pregnancy outcomes in women with hypertensive disease of pregnancy.

Hypertensive disease of pregnancy (HDP) is one of the most important causes of increased maternal mortality and perinatal complications during pregnancy. We investigated the pregnancy outcomes of 156 HDP patients (65 gestational hypertension [GH], 13 chronic hypertension [CH], 74 preeclampsia-eclampsia [PE-EC], and 4 superimposed on PE [CH with PE]). In patients with different types of HDP, levels of soluble fms like tyrosine kinase-1 (sFlt-1), placental growth factor (PlGF)-1, and prokinin-1 (PROK1) were measured and compared. The predictive efficacy of these indicators was evaluated using receiving operating characteristics curves and area under the curve. Results showed that the PE cohort had a higher sFlt-1/PlGF ratio (46.12 [39.24, 68.85]) and PROK1 (498.84 [213.67, 678.30] pg/mL) level than the GH (sFlt-1/PlGF, 32.3 [21.98, 58.00], PROK1 300.77[250.0, 345.29]pg/mL) and CH cohort (sFlt-1/PlGF, 37.49 [32.68, 39.68], PROK1, 281.48 [229.25, 453.94]pg/mL). In the HDP cohort, 54 patients experienced adverse pregnancy events, and the sFlt-1/PlGF ratio, PROK1, and the combined indicators (sFlt-1/PlGF ratio and PROK1) were excellent predictors of adverse pregnancy events, especially for PE patients.

A retrospective study of WeChat app-based health management for patients with gestational diabetes mellitus

Background This study aimed to explore and evaluate the effectiveness of WeChat app-based health management in patients with gestational diabetes mellitus (GDM). Methods This study retrospectively analysed a cohort of 100 patients with GDM. Since the application we used went live in April 2023, we enrolled patients from April 2022 to June 2022 into the control group (n = 50) and patients from April 2023 to June 2023 into the observation group (n = 50) for contemporaneous comparisons. The control group received routine health management procedures, whereas the observation group received app-based health management. Fasting plasma glucose, 2-hour postprandial blood glucose, and haemoglobin A1c levels were compared between the two groups before and four and eight weeks after app management; the incidence of adverse pregnancy outcomes and weight gain before and after pregnancy was also compared between the two groups. Results Fasting plasma glucose and 2-hour postprandial blood glucose levels were lower in the observation group than in the control group four and eight weeks after intervention (p < 0.05). In addition, the incidence of adverse pregnancy outcomes and weight gain was lower in the observation group than in the control group (p < 0.05). Conclusions Implementing WeChat app-based health management can effectively improve blood glucose levels, reduce adverse pregnancy events in patients with GDM, and decrease weight gain during pregnancy.

Recurrent Events in Subsequent Pregnancies: A Case of Severe Maternal Morbidity.

Recurrent Events in Subsequent Pregnancies: A Case of Severe Maternal Morbidity.

Pregnancy, aortic events, and neonatal and maternal outcomes.

This study aimed to evaluate the association between pregnancy and aortic complications and determine related maternal and neonatal outcomes. Records of pregnancies and neonatal deliveries from the Taiwan National Health Insurance Research Database from 2000 to 2020 were retrieved. The incidence rate ratio (IRR) was calculated to evaluate the risk factors for aortic events. Survival analysis was conducted to compare maternal and neonatal mortality with and without aortic events. A total of 4 785 266 pregnancies were identified among 2 833 271 childbearing women, and 2 852 449 delivered neonates. In the vulnerable and control periods, 57 and 20 aortic events occurred, resulting in incidence rates of 1.19 and 0.42 aortic events per 100 000 pregnancies, respectively. Pregnancy was established as a risk factor for aortic events (IRR: 2.86, P < .001). The 1-year maternal mortality rate was significantly higher in pregnancies with aortic events than in those without such events (19.3% vs. 0.05%, P < .001). Neonates whose mothers experienced aortic events had a higher late mortality (6.3% vs. 0.6%, P < .001). The association between pregnancy and aortic events was established in this study. The results revealed that women are at risk of aortic events from the gestational period to 1-year postpartum. Maternal mortality was significantly higher in pregnancies with aortic events than in those without. A higher late mortality and more complications were noted for neonatal deliveries with maternal aortic events. Early awareness of pregnant women at risk of aortic events-especially those with concomitant hypertensive disorders of pregnancy, contributive family histories, or aortopathy-is crucial.

Prognostic Value of Serum D-dimer in Predicting Outcomes in COVID-19 Positive Pregnant Women

Background: Combined effects of pregnancy induced hypercoagulability and SARS-CoV-2 infection place pregnant women with COVID-19 disease at high risk of severe outcome. COVID-19 severity has also been associated with serum D-dimer, a biomarker reflecting coagulation and fibrin degradation, in general populations. Despite its prognostic value in pregnant women, the prognostic value of this finding particularly in maternal outcomes remains less understood. The aim of this study was to determine whether elevated serum D-dimer levels in pregnant COVID-19 positive women are of prognostic significance for severe maternal outcomes. Methods: This retrospective observational study included 62 third trimester COVID 19 positive pregnant women admitted to the Department of Obstetrics and Gynecology, BSMMU, Dhaka from March 2019 to February 2020. Serum D-dimer were measured at admission and day 7, 14. D-dimer levels were related to clinical outcomes and statistically evaluated using chi square tests and logistic regression at p &lt; 0.05. Results: Significantly associated with higher risk of severe outcomes, all of which included ICU admission, respiratory complications and adverse pregnancy events is elevated D-dimer levels (≥1.5 mg/L). In logistic regression analysis, patients with D-dimer levels of ≥1.5 mg/L had 3.5-fold greater odds of severe outcomes (OR 3.486; 95% CI, 1.184 to 10.263; p = 0.023). D-dimer had a sensitivity of 64.29%, 67.55% specificity in predicting severe outcomes. Conclusion: Serum D-dimer is valuable prognostic marker of disease severity in pregnant COVID-19 positive women and may be used for early risk assessment and clinical decision making. Routine measurement may help identify early high risk cases in order to improve maternal outcomes.

Omalizumab safety concerns.

IgE and mast cells play key roles in the pathophysiology of allergic diseases. In 2003, omalizumab was the first anti-IgE mAb licensed in the United States when initially US Food and Drug Administration-approved for the treatment of allergic asthma. Since that time, the number of US Food and Drug Administration-approved indications for treatment with omalizumab has grown to include chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and food allergy. Although omalizumab is generally considered relatively safe and well tolerated, a number of safety concerns have been raised since its initial approval. These concerns focus on specific adverse events of interest, including anaphylaxis, pregnancy, malignancy, cardiovascular events, and infections. For each of these issues, data from clinical trials and postmarketing surveillance have been evaluated extensively. In this review, we examine these safety data, provide context for safety and risk assessments, and summarize a safety profile for each of the adverse events of interest. In doing so, we aim to provide a resource for shared decision making when treatment with omalizumab is being considered.

Role of In Vitro Fertilization (IVF) in Unexplained Infertility Management: A Systematic Review.

Unexplained infertility presents a significant reproductive challenge globally, affecting couples who are unable to conceive despite comprehensive fertility evaluations. This condition carries emotional, physical, and economic burdens, with a moderate to high prevalence, underscoring the need for effective interventions. In vitro fertilization (IVF) has emerged as a crucial treatment option for unexplained infertility, offering a unique approach to conception when traditional diagnostic tests fail to identify specific causes. However, the efficacy, safety, and comparative benefits of IVF in this context warrant comprehensive evaluation through systematic reviews. A systematic review was conducted to assess the effectiveness and outcomes of IVF in cases of unexplained infertility. Inclusion criteria encompassed peer-reviewed studies focusing on human subjects diagnosed with unexplained infertility and evaluating IVF outcomes. Comprehensive searches were performed across electronic databases, and eligible studies were selected based on predetermined criteria. Data extraction was conducted independently by two researchers, and quality assessment was performed using standardized tools. The search yielded 10 studies comprising 73,884 patients, published between 2000 and 2021. Variability in methodological quality was observed across randomized controlled trials, while cohort studies demonstrated consistently high quality. Studies assessed outcomes like pregnancy success rate (46.2-47.9%), live birth rates (29.4-49%), time to pregnancy (9-14 months), cost-effectiveness, and adverse events such as ovarian hyperstimulation syndrome. Elective single embryo transfer (eSET) was found effective, and donor oocytes had higher live birth rates than autologous cycles. Multiple gestations and canceled IVF cycles were common. The systematic review underscores the complexity of IVF treatment for unexplained infertility, with variability in outcomes influenced by multiple factors. Strategies such as eSET and donor oocyte cycles show promise in optimizing treatment efficacy and safety. However, challenges such as heterogeneity, moderate to high risk of bias across studies, and cost considerations warrant careful interpretation and further research.

Patient-reported pregnancy loss and maternal complications: Insights from the sickle cell disease implementation consortium.

Sickle cell disease (SCD) is associated with complications during pregnancy and can negatively influence maternal outcomes. Our study aimed to determine the prevalence and predictors of maternal morbidity among participants enrolled in an eight-site SCD Implementation Consortium (SCDIC) registry. We conducted a cross-sectional analysis of female registry participants, aged 15-45 years, with a confirmed diagnosis of SCD. Participants completed a survey of self-reported pregnancies and outcomes. Seven hundred and thirty-eight individuals had at least one pregnancy event, with 1076 live births. Twenty percent reported a pregnancy loss or fetal demise. Of the 1076 live births, 75% involved at least one complication. The most prevalent complications were pain crises (61.1%) and pregnancy requiring blood transfusion(s) (33.0%). Multiparous individuals with a prior occurrence of a complication in a previous pregnancy had higher odds of recurrence of the same complication in subsequent pregnancies (i.e., previous acute crisis was associated with subsequent acute pain events odds ratio [OR]: 3.13; 95% confidence interval [CI]: 2.06-4.76) and prior transfusion requiring another transfusion (OR: 3.22; 95% CI: 2.01-5.16). Individuals reported a high prevalence of pregnancy loss and maternal complications. Our findings underscore the importance of preconception counseling and early initiation of perinatal care in SCD.

Acquired Partial Lipodystrophy: Clinical Management in a Pregnant Patient.

Pregnancy represents an additional challenge to the complex clinical picture of lipodystrophy disorders, and the management of such conditions with related comorbidities has been underreported. This work aims to outline the risk associated with a pregnancy event for women dealing with acquired partial lipodystrophy and the need for diverse but specialized care. We report on the successful pregnancy outcome of a 28-year-old woman with an acquired partial form of lipodystrophy related to an allogenic bone marrow transplant that occurred at pediatric age. Although metabolic control was challenging, glucose levels progressively improved during the pregnancy, and triglycerides increased less than expected. The periodic monitoring of leptin levels showed a progressive increase with a peak in the third trimester (41.53 ng/mL), followed by a fast decline the day after giving birth, with a lower basal level than the prepregnancy period. However, preterm delivery occurred associated with cardiac complications in the mother. A total of 12 studies were retrieved concerning women aged 14 to 38 years with various lipodystrophy phenotypes. Diabetes and hypertriglyceridemia were the most common comorbidities. Most women had successful pregnancies despite gestational complications (including miscarriages), preterm and emergency deliveries, and newborns undergoing partum or postpartum transient or chronic complications. Lipodystrophy disorders expose both mothers and children to very high risk. Intensive monitoring and care of all potential clinical complications should be planned and carried out by a multidisciplinary team before, during, and after the pregnancy. Leptin secretion during pregnancy should be investigated more deeply in these patients.

Relationship between Natural Coagulation Inhibitor and Obstetrics History in Predicting Thromboembolic Events during Pregnancy

Background: There is a low level of information on natural coagulation inhibitors in this environment and whether the early detection of its deficiencies could serve as a risk assessment tool for thromboembolic events in pregnancy. This study aims to determine the relationship between natural coagulation inhibitors and obstetrics history in predicting thromboembolic events during pregnancy. Methods: The study was a comparative cross-sectional hospital-based study conducted among one hundred and fifty pregnant women and age-matched healthy non-pregnant control. Obstetrics history was obtained via questionnaire and other information was extracted from case notes. Blood specimens were obtained for laboratory assessment of natural coagulation inhibitors (Protein C, S, and antithrombin III) at various trimesters of pregnancy. Data were analyzed using SPSS version 23. Results: All NCIs decreased across the three trimesters of pregnancy but only the mean protein S and antithrombin III decreased with statistical significance (p = 0.001). Protein C, S, and antithrombin III did not show a statistically significant association when correlated with obstetrics histories. Conclusion: Although this study demonstrated a progressive decrease in the levels of NCIs across various trimesters of pregnancy, the use of NCIs as predictive tools for thromboembolic events in women with past bad obstetrics histories was not established but rather for risk assessment during pregnancy regardless of past obstetrics history.

Describing Adverse Pregnancy Events and Pregnancy-Associated Death Among Veterans

Describing Adverse Pregnancy Events and Pregnancy-Associated Death Among Veterans

Trends in Adverse Pregnancy Events Among Veterans: Racial Disparities and Care Coordination

Trends in Adverse Pregnancy Events Among Veterans: Racial Disparities and Care Coordination

The safety of a dolutegravir (DTG)-based antiretroviral treatment (ART) regimen for pregnancy and birth outcomes in Ethiopia: evidence from multicenter cohort study

BackgroundA dolutegravir (DTG)-based antiretroviral regimen has been rolled out for pregnant women in low- and middle-income countries since 2020. However, available safety data are limited to a few clinical trials and observational studies. Hence, we present real-world pregnancy and birth outcome safety data from a large sample multicenter cohort study in Ethiopia.MethodsA retrospective cohort study was conducted in fourteen hospitals across Ethiopia from 2017 to 2022. HIV-infected pregnant women were followed from the date of prevention of mother-to-child transmission (PMTCT) care enrolment until the infant was 6–8 weeks old. The primary safety outcome was a composite of adverse pregnancy events comprising spontaneous abortion, intrauterine fetal death (IUFD) before onset of labor, preterm birth, and maternal death. Additionally, a composite adverse birth outcome was assessed, comprising intrapartum fetal demise, low birth weight, and neonatal death. Finally, a composite of adverse pregnancy or birth outcome was also investigated. The exposure of interest was the antiretroviral treatment (ART) regimen used during pregnancy for PMTCT of HIV.ResultsDuring the study period, 2643 women were enrolled in routine PMTCT care. However, 2490 (92.2%) participants were eligible for the study. A total of 136/1724 (7.9%, 95% CI: 6.7–9.3%) women experienced adverse pregnancy outcomes. Fewer women in the DTG-based group (5.4%, 95% CI: 3.7–7.5%) had adverse pregnancy outcomes than in the Efavirenz (EFV)-based group (8.3%, 95% CI: 6.6–10.3%), P = 0.004. After controlling for baseline differences, the DTG group had a 43% lower risk of adverse pregnancy outcomes (adjusted odd ratio (AOR), 0.57; 95% CI, 0.32–0.96%) and a 53% lower risk of preterm birth (AOR, 0.47; 95% CI, 0.22–0.98%) compared to the EFV group. A total of 103/1616 (6.4%, 95% CI: 5.2–7.7%) women had adverse birth outcomes. Although the difference was not statistically significant, fewer women in the DTG group (30/548; 5.5%, 95% CI: 3.7–7.7%) than in the EFV group (57/830; 6.9%, 95% CI: 5.2–8.8%) had adverse birth outcomes.ConclusionsIn this study, we observed that DTG-based regimens were associated with better pregnancy and birth outcome safety profiles, reaffirming the WHO recommendation. However, a prospective study is recommended to assess uncaptured maternal and perinatal adverse outcomes, such as congenital abnormalities, and infant growth and neurocognitive development.

Novel insights into causal effects of maternal nonalcoholic fatty liver disease on adverse pregnancy outcomes: evidence from Human Genetics and Mendelian Randomization Study.

Observational studies have associated nonalcoholic fatty liver disease (NAFLD) with adverse pregnancy events, but findings show heterogeneity, leaving the causal direction and mediating pathways unclear. We aimed to investigate the causal relation between NAFLD and various pregnancy events, and to elucidate the underlying mediating pathways while determining the proportion of this correlation that is mediated through these pathways. A genome-wide association study involving over 6 million participants employing Mendelian randomization (MR) and mediation analysis was performed. The study used genetically predicted NAFLD as exposures and cardiometabolic traits as mediators, with various adverse pregnancy events as outcomes. The main analysis was performed using the inverse variance weighted (IVW) approach, while sensitivity analyses included the weighted median, weighted mode, MR-Egger, and MR-PRESSO methods. Mediation analyses were performed using a two-step MR framework. In this MR cohort study, NAFLD was found to be strongly associated with elevated risks of GDM (P = 0.019 for the discovery dataset, P < 0.001 for the discovery dataset) and HDPs, including any HDP (P < 0.001 for the both datasets), gestational hypertension (P = 0.007 for the discovery dataset, P < 0.001 for the discovery dataset), and pre-eclampsia or eclampsia (P = 0.040 for the discovery dataset, P < 0.001 for the discovery dataset). However, no significant associations were found with hemorrhage in early pregnancy, postpartum hemorrhage, preterm birth, or offspring birthweight for both datasets. Cardiometabolic traits played a significant mediating role in these associations, rather than solely acting as confounding factors. This study provided evidence supporting a correlation between NAFLD and a higher risk of adverse pregnancy events and introduces some new insights. These findings may inform preventions and interventions for remediating adverse pregnancy outcomes attributable to NAFLD.

Fetal growth restriction and placental defects in obese mice are associated with impaired decidualisation: the role of increased leptin signalling modulators SOCS3 and PTPN2

Decidualisation of the endometrium is a key event in early pregnancy, which enables embryo implantation. Importantly, the molecular processes impairing decidualisation in obese mothers are yet to be characterised. We hypothesise that impaired decidualisation in obese mice is mediated by the upregulation of leptin modulators, the suppressor of cytokine signalling 3 (SOCS3) and the protein tyrosine phosphatase non-receptor type 2 (PTPN2), together with the disruption of progesterone (P4)-signal transducer and activator of transcription (STAT3) signalling. After feeding mice with chow diet (CD) or high-fat diet (HFD) for 16 weeks, we confirmed the downregulation of P4 and oestradiol (E2) steroid receptors in decidua from embryonic day (E) 6.5 and decreased proliferation of stromal cells from HFD. In vitro decidualised mouse endometrial stromal cells (MESCs) and E6.5 deciduas from the HFD showed decreased expression of decidualisation markers, followed by the upregulation of SOCS3 and PTPN2 and decreased phosphorylation of STAT3. In vivo and in vitro leptin treatment of mice and MESCs mimicked the results observed in the obese model. The downregulation of Socs3 and Ptpn2 after siRNA transfection of MESCs from HFD mice restored the expression level of decidualisation markers. Finally, DIO mice placentas from E18.5 showed decreased labyrinth development and vascularisation and fetal growth restricted embryos. The present study revealed major defects in decidualisation in obese mice, characterised by altered uterine response to E2 and P4 steroid signalling. Importantly, altered hormonal response was associated with increased expression of leptin signalling modulators SOCS3 and PTPN2. Elevated levels of SOCS3 and PTPN2 were shown to molecularly affect decidualisation in obese mice, potentially disrupting the STAT3-PR regulatory molecular hub.

Adverse fetal/neonatal and obstetric outcomes in pregnancies with both maternal and fetal heart disease

ObjectiveTo investigate fetal/neonatal and obstetric events in pregnancies with both maternal and fetal heart disease.Study designFrom the CARPREG database, singleton pregnancies (>24 weeks) in patients with structural heart disease that underwent fetal/neonatal echocardiograms were selected and separated in two groups: maternal heart disease only (M-HD) and maternal and fetal heart disease (MF-HD). Differences in adverse fetal/neonatal (death, preterm birth, and small for gestational age) and obstetric (preeclampsia/eclampsia) outcomes between groups were analyzed.ResultsFrom 1011 pregnancies, 93 had MF-HD. Fetal/neonatal events (38.7% vs 25.3%, p = 0.006) and spontaneous preterm birth (10.8% vs 4.9%, p = 0.021) were more frequent in MF-HD compared to M-HD, with no difference in obstetric events. MF-HD remained as a significant predictor of fetal/neonatal events after adjustment (OR:1.883; 95% CI:1.182–3.000; p = 0.008).ConclusionsPregnancies with MF-HD are at risk of adverse fetal/neonatal events and spontaneous preterm birth. Larger studies are needed to determine their association with preeclampsia.

Association between pregnancy loss and depressive symptoms in women: a population-based study

BackgroundDepression is a common mental disorder with a much higher prevalence in women than in men. Although there has been a gradual increase in research on the association between reproductive health and depression, there is still some inconsistency in the evidence of the relationship between pregnancy loss and depression. This study aimed to investigate the relationship between pregnancy loss and depressive symptoms.MethodsWe analyzed data from the 2007–2020 National Health and Nutrition Examination Survey (NHANES), which included female participants aged 20 to 80 years. Pregnancy loss was determined based on participants’ self-reported number of pregnancies and pregnancy outcomes. Depressive symptoms were measured using the Patient Health Questionnaire (PHQ-9, score ≥ 10). Multivariate logistic regression, smoothed curve fitting, and generalized additive modeling were used to examine the association between pregnancy loss and depression. We also performed sensitivity analyses and subgroup analyses to verify the robustness and specificity of the findings.ResultsA total of 12,873 female participants were included in our study, of which 1,595 (12.39%) were categorized as depressed. Multivariate logistic regression results indicated that experiencing a pregnancy loss increased the risk of prevalence of depression in women (for 1 loss: OR = 1.31, 95% CI 1.15,1.50; for 2 or more losses: OR = 1.58, 95% CI 1.38, 1.81). When sensitivity analyses were performed, an association between pregnancy loss and depression was found in both multivariate linear regressions with PHQ-9 scores as a continuous variable and multivariate logistic regressions with a threshold of 5 PHQ-9 scores. The association between pregnancy loss and depression remained stable across subgroups.ConclusionPregnancy loss correlated with elevated PHQ-9 scores and a heightened risk of depression in adult women across the United States. Focusing on the incidence of adverse pregnancy events in the female population may help prevent or early recognize the onset of depression.

Approach to Glomerular Disease in Pregnancy

The presence of glomerular diseases in pregnancy presents challenges to both patients and nephrologists. The preconception planning in patients with kidney disease involves comprehensive stratification, treatment optimization, and comorbidity assessment, requiring nephrologists to engage in well-informed decision-making processes alongside their patients. There is a necessity for a multidisciplinary approach to meet their complex healthcare needs. Effective control of blood pressure, proteinuria, and disease activity are pivotal in mitigating adverse pregnancy events. This comprehensive review intends to equip nephrologists with the requisite knowledge and understanding to navigate the intricate landscape of glomerular diseases in pregnancy. It delves into the challenges associated with the diagnosis of glomerular diseases, the significance of preconception counseling, and the nuances of antenatal and postnatal care. Additionally, the article provides insights into the management and prognosis of glomerular diseases, shedding light on the judicious use of immunosuppression as a therapeutic tool.

Venous Thromboembolism Prophylaxis Should Be Recommended for Antepartum Admissions and Cesarean Delivery if Age and Body Mass Index are Greater Than 35.

Venous thromboembolism (VTE) is a major cause of maternal morbidity and mortality. Current expanded treatment recommendations result in the inclusion of a large percentage of the obstetric population, which has limited their adoption. The purpose of this study was to identify a population at high risk for VTE, with minimal impact on the number of patients that would qualify for expanded treatment. We performed a retrospective analysis of a large obstetric population. International Classification of Diseases, 10th Revsion (ICD-10) codes for VTE were used to identify patients presenting for obstetric or postpartum (PP) care from January 2016 to March 2018. The review focused on high-risk factors (history of VTE or high-risk thrombophilia), antepartum hospital admissions that were >72 hours in the previous 30 days, use of sequential compression devices, body mass index (BMI; kg/m2), age, and mode of delivery. Pharmacologic treatment efficacy was set at 90, 75, or 50%. During the 27-month review period, there were 120,235 deliveries and 93 had a VTE event in the index pregnancy or within 4 weeks PP (7.7/10,000 births). A history of VTE or high-risk thrombophilia was seen in 25.8% of cases. Antepartum admission was noted in 40.9%, and the combination of cesarean delivery (CD) with age and BMI ≥35 (Age + BMI + CD) was noted in 17.3% of PP cases. Targeting these latter two groups for VTE prophylaxis with a 75% efficacy suggests that 34% of the VTE events would likely have been prevented while increasing the total population treated by approximately 2%. Expanding pharmacologic prophylactical coverage to include an antepartum admission of >72 hours and those with Age + BMI + CD would result in about a one-third reduction in total VTE events with about 2% requiring treatment. These data support some of the suggested recommendations for expanded pharmacological deep venous thrombosis prophylaxis. · CD, and BMI and age >35 are high-risk factors for VTE.. · Antepartum admission >72 hours is a high-risk factor for VTE.. · Targeting antepartum admissions, CD, and BMI and age >35 would reduce VTE events by about 33%..

Exposure to golimumab during pregnancy: Results from the Company's global safety database.

Data on the use of golimumab (GLM) during pregnancy are limited. This study evaluated pregnancy outcomes in women treated with GLM during pregnancy. Cumulative data on GLM-exposed pregnancies from the Company's global safety database (GSD) are summarized. Cases were medically confirmed maternal exposures to GLM during pregnancy or within 3 months prior to conception with a reported pregnancy outcome. Pregnancy outcomes (e.g., live births) and congenital anomalies in prospectively reported cases (i.e., pregnancy outcome not known when first reported to the company) are presented in a descriptive manner. As of May 31, 2022, 261 prospectively reported pregnancies exposed to GLM were reported in the GSD: 214 (82.0%) live births (including six sets of twins), 31 (11.9%) spontaneous abortions (including one set of twins), 13 (5.0%) induced/elective abortions, 2 (0.8%) reported intrauterine death/still birth, and 1 (0.4%) fetal adverse event in an ongoing pregnancy. The majority of pregnancies had exposure to GLM at least in the first trimester of pregnancy. In total, seven congenital anomalies (7/261; 2.7%) were reported. Of these seven congenital anomalies, five were considered major according to EUROCAT classification version 1.4. Among the five prospectively reported congenital anomalies noted in live births (5/214; 2.3%), four were classified as major (4/214; 1.8%). The rates of adverse pregnancy outcomes and major congenital anomalies in prospectively reported pregnancy cases with exposure to GLM in the Company's GSD were consistent with published background rates for the general population.