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

2021 ◽  
Vol 11 ◽  
Author(s):  
Carla Carnovale ◽  
Enrico Tombetti ◽  
Vera Battini ◽  
Faizan Mazhar ◽  
Sonia Radice ◽  
...  
Keyword(s):  
Systematic Review ◽  
Targeted Therapy ◽  
Pregnant Women ◽  
Case Reports ◽  
Adverse Event Reporting System ◽  
Reporting Odds Ratio ◽  
Limited Data ◽  
Childbearing Age ◽  
Real World Data ◽  
In Pregnancy

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.

scholarly journals Immune checkpoint inhibitors-related myocarditis in patients with cancer: an analysis of international spontaneous reporting systems

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rulan Ma ◽  
Quanziang Wang ◽  
Deyu Meng ◽  
Kang Li ◽  
Yong Zhang
Keyword(s):  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Adverse Drug Events ◽  
Cytotoxic T Lymphocyte ◽  
Checkpoint Inhibitors ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Real World Data ◽  
Safety Issues

Abstract Background Immune checkpoint inhibitors-induced myocarditis presents unique clinical challenges. Here, we assessed post-marketing safety of cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors by mining the real-world data reported in two international pharmacovigilance databases. Methods We analyzed immune checkpoint inhibitors (ICIs)-associated fatal adverse drug events (ADEs) reports from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) collected from July 1, 2014 to December 31, 2019 and data from EudraVigilance (EV) database accessed on February 29, 2020. Three different data mining approaches were used to detect the signal of fatal myocarditis caused by ICIs. Results Based on 7613 ICIs-related ADEs reported to the EV database and 5786 ICIs-associated ADEs submitted to the FAERS database, the most frequently reported ADE was ipilimumab-related colitis. For myocarditis, nivolumab-associated myocarditis was the most common. Among the five fatal toxic effects associated with ICIs, the lethality rate of myocarditis was the highest. Therefore, we further analyzed ICI-associated myocarditis and found that elderly patients and male patients were more likely to develop ICIs-related myocarditis. The results of signal detection showed that the risk signal of avelumab-related myocarditis detected by reporting odds ratio (ROR) method and proportional reporting ratios (PRR) method was the highest, whereas the signal strength of ipilimumab-related myocarditis detected by Bayesian confidence propagation neural networks (BCPNN) method was the strongest. Conclusion The findings of this study indicated the potential safety issues of developing myocarditis when using ICIs, which were consistent with the results of previous clinical trials and could provide a reference for clinical workers when using ICIs.

scholarly journals Prevalence, incidence and bothersomeness of urinary incontinence in pregnancy: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Heidi F. A. Moossdorff-Steinhauser ◽  
Bary C. M. Berghmans ◽  
Marc E. A. Spaanderman ◽  
Esther M. J. Bols
Keyword(s):  
Systematic Review ◽  
Urinary Incontinence ◽  
Pregnant Women ◽  
Health Care Providers ◽  
Meta Analysis ◽  
Care Providers ◽  
Case Definitions ◽  
Monthly Basis ◽  
Policy Makers ◽  
In Pregnancy

Abstract Introduction and hypothesis Urinary incontinence (UI) is a common and embarrassing complaint for pregnant women. Reported prevalence and incidence figures show a large range, due to varying case definitions, recruited population and study methodology. Precise prevalence and incidence figures on (bothersome) UI are of relevance for health care providers, policy makers and researchers. Therefore, we conducted a systematic review and meta-analysis to investigate the prevalence and incidence of UI in pregnancy in the general population for relevant subgroups and assessed experienced bother. Methods All observational studies published between January 1998 and October 2018 reporting on prevalence and/or incidence of UI during pregnancy were included. All women, regardless of weeks of gestation and type of UI presented in all settings, were of interest. A random-effects model was used. Subgroup analyses were conducted by parity, trimester and subtype of UI. Results The mean (weighted) prevalence based on 44 included studies, containing a total of 88.305 women, was 41.0% (range of 9–75%). Stress urinary incontinence (63%) is the most prevalent type of UI; 26% of the women reported daily loss, whereas 40% reported loss on a monthly basis. Bother was experienced as mild to moderate. Conclusions UI is very prevalent and rising with the weeks of gestation in pregnancy. SUI is the most common type and in most cases it was a small amount. Bother for UI is heterogeneously assessed and experienced as mild to moderate by pregnant women.

scholarly journals Systematic review to investigate the safety of induction and augmentation of labour among pregnant women with iron-deficiency anaemia

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e021793 ◽  
Author(s):  
Kathryn Bunch ◽  
Nia Roberts ◽  
Marian Knight ◽  
Manisha Nair
Keyword(s):  
Systematic Review ◽  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anaemia ◽  
Case Reports ◽  
Case Series ◽  
Severe Anaemia ◽  
Risk Of Bias ◽  
Deficiency Anaemia ◽  
Increased Risk

ObjectiveTo conduct a systematic review to investigate the safety of induction and/or augmentation of labour compared with spontaneous-onset normal labour among pregnant women with iron-deficiency anaemia.DesignSystematic review.SettingStudies from all countries, worldwide.PopulationPregnant women with iron-deficiency anaemia at labour and delivery.InterventionAny intervention related to induction and/or augmentation of labour.Outcome measuresPrimary: Postpartum haemorrhage (PPH), heart failure and maternal death. Secondary: Emergency caesarean section, hysterectomy, admission to intensive care unit.MethodWe searched 10 databases, including Medline and Embase, from database inception to 1 October 2018. We included all study designs except cross-sectional studies without a comparator group, case reports, case series, ecological studies, and expert opinion. The searches were conducted by a healthcare librarian and two authors independently screened and reviewed the studies. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approachto ascertain risk of bias and conducted a narrative synthesis.ResultsWe identified 3217 journal articles, 223 conference papers, 45 dissertations and 218 registered trials. Ten articles were included for full-text review and only one was found to fulfil the eligibility criteria. This was a retrospective cohort study from India, which showed that pregnant women with moderate and severe anaemia could have an increased risk of PPH if they underwent induction and/or augmentation of labour, but the evidence was weak (graded as ‘high risk of bias’).ConclusionThe best approach is to prevent anaemia, but a large number of women in low-to-middle-income countries present with severe anaemia during labour. In such women, appropriate peripartum management could prevent complications and death. Our review showed that at present we do not know if induction and augmentation of labour is safe in pregnant women with iron-deficiency anaemia and further research is required.PROSPERO registration numberCRD42015032421.

scholarly journals Antiviral Treatment on Pregnancy with COVID-19 Infection : A Systematic Review

2021 ◽  
Vol 4 (2s) ◽  
pp. 78-85
Author(s):  
Tigor Peniel Simanjuntak ◽  
◽  
Angela Putri Kakerissa ◽  
Grady Ivan Kurniawan
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Pregnant Women ◽  
Gestational Age ◽  
Treatment Duration ◽  
Case Reports ◽  
Antiviral Treatment ◽  
Inclusion Criteria ◽  
Duration Of Treatment ◽  
Retrospective Case

Abstract Objective to evaluate antiviral treatment, duration, and side effects on pregnant women based on gestational age and severity of COVID-19 infection. Method: a systematic review of antiviral treatment, duration, and side effects on pregnant women based on gestational age and severity of COVID-19 infection. Systematic review was conducted following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) Statement. Result 948 papers accessed through Pubmed, Scopus, Science Direct, Cohcrane, and other with keywords “Antiviral”, “Pregnancy” “Pregnant” “Coronavirus” “COVID-19” “SARS-CoV-2”. Duplicate papers were excluded (n=302), topics and abstracts that do not meet the criteria (n=612), and 25 papers that did not meet the inclusion criteria. 9 papers that meet the inclusion criteria (case reports and cohort retrospective case study) discussed 20 pregnant women with COVID-19 infection (16 moderate and severe cases received Remdesivir, 3 moderate and mild cases received Lopinavir-ritonavir combination, and 1 moderate case received Arbidol). Conclusion, remdesivir is an antiviral frequently used in pregnancy on trimester II and III with severe COVID-19 infection with a duration of treatment of 5-10 days. Remdesivir should be monitored because some show side effects of increasing liver function. Key word: Antiviral, Pregnant, COVID-19

scholarly journals Immune checkpoint inhibitors-related myocarditis in patients with cancer: an analysis of international spontaneous reporting systems

2020 ◽  
Author(s):  
Rulan Ma ◽  
Quanziang Wang ◽  
Deyu Meng ◽  
Kang Li ◽  
yong zhang
Keyword(s):  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Adverse Drug Events ◽  
Cytotoxic T Lymphocyte ◽  
Checkpoint Inhibitors ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Real World Data ◽  
Safety Issues

Abstract Background: Immune checkpoint inhibitors induced myocarditis presents unique clinical challenges. Here, we assessed post-marketing safety of cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors by mining the real-world data reported in two international pharmacovigilance databases. Methods: We analyzed immune checkpoint inhibitors (ICIs)-associated fatal adverse drug events (ADRs) reports from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) collected from July 1, 2014 to December 31, 2019 and data from EudraVigilance (EV) database accessed on February 29, 2020. Three different data mining approaches were used to detect the signal of fatal myocarditis caused by ICIs. Results: Based on 7613 ICIs-related ADEs reported to the EV database and 5786 ICIs-associated ADEs submitted to the FAERS database, the most frequently reported ADE was ipilimumab-related colitis. For myocarditis, nivolumab-associated myocarditis was the most common. Among the five fatal toxic effects associated with ICIs, the lethality rate of myocarditis was the highest. Therefore, we further analyzed ICI-associated myocarditis and found that elderly patients and male patients were more likely to develop ICIs-related myocarditis. The results of signal detection showed that the risk signal of avelumab-related myocarditis detected by reporting odds ratio (ROR) method and proportional reporting ratios (PRR) method was the highest, whereas the signal strength of ipilimumab-related myocarditis detected by Bayesian confidence propagation neural networks (BCNPP) method was the strongest. Conclusion: The findings of this study indicated the potential safety issues of developing myocarditis when using ICIs, which are consistent with the results of previous clinical trials and can provide a reference for clinical workers when using ICIs.

scholarly journals Remotely delivered interventions to support women with symptoms of anxiety in pregnancy: a mixed methods systematic review of quantitative and qualitative evidence (Preprint)

2021 ◽  
Author(s):  
Kerry Evans ◽  
Stefan Rennick-Egglestone ◽  
Serena Cox ◽  
Yvonne Kuipers ◽  
Helen Spiby
Keyword(s):  
Systematic Review ◽  
Pregnant Women ◽  
Quantitative Data ◽  
Meta Analysis ◽  
Treatment Options ◽  
Social Science Citation Index ◽  
Cochrane Library ◽  
Access To Treatment ◽  
On Line ◽  
In Pregnancy

BACKGROUND Symptoms of anxiety are common in pregnancy, with severe symptoms associated with negative outcomes for women and babies. Low level psychological therapy is recommended as first line treatment options for women with mild to moderate anxiety, with the aim to prevent an escalation of symptoms and provide women with coping strategies. Remotely delivered interventions have been suggested to improve access to treatment and support for women in pregnancy and provide a cost-effective, flexible and timely solution. OBJECTIVE To identify and evaluate remotely delivered, digital or on-line interventions to support women with symptoms of anxiety in pregnancy. METHODS A mixed method systematic review following a convergent segregated approach to synthesise the qualitative and quantitative data. The ACM Digital Library, AMED, ASSIA, CRD, CENTRAL, the Cochrane Library, CINAHL, EMBASE, HTA, IEEE Xplore, JBI, Maternity and Infant Care, Medline, PsycINFO and the Social Science Citation Index were searched in October 2020. Quantitative or qualitative primary research including pregnant women which evaluated remotely delivered interventions reporting measures of anxiety, fear, stress, distress, women’s views, feedback and opinions were included in the review. RESULTS Three qualitative and 14 were quantitative studies included. Populations included a general antenatal population, and pregnant women with anxiety and depression, fear of childbirth, insomnia and pre-term labour. Interventions included CBT, Problem Solving, Mindfulness and Educational designs. Most interventions were delivered via on-line platforms and 8 included direct contact from trained therapists or coaches. A meta-analysis of the quantitative data found for I-CBT and facilitated interventions there was observed beneficial effect in relation to the reduction of anxiety scores (SMD=-0.49; 95% CI=-0.75 to -0.22; SMD=-0.48; 95% CI=-0.75 to -0.22). However, due to limitations in the amount of available data and study quality, the findings should be interpreted with caution. Synthesised findings from quantitative and qualitative data found some evidence to suggest that interventions are more effective when women are motivated to maintain regular participation in interventions. Participation may be enhanced by providing regular contact with therapists, targeting interventions for women with anxiety symptoms; providing peer support forums; including components of relaxation and cognitive based skills; and providing sufficient sessions to develop new skills without being too time consuming. CONCLUSIONS There is limited evidence to suggest that pregnant women may benefit from remotely delivered interventions. The synthesised findings highlighted components of interventions which may improve the effectiveness and acceptability of remotely delivered interventions. These include providing women with contact with a therapist, healthcare professional or peer community. Women may be more motivated to complete interventions which are perceived as relevant or tailored to their needs and situations. Remote interventions may also provide women with greater anonymity to help them feel more confident in disclosing their symptoms.

scholarly journals Differences in pregnancy and perinatal outcomes among symptomatic versus asymptomatic COVID-19-infected pregnant women: a systematic review and meta-analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Durray Shahwar A. Khan ◽  
La-Raib Hamid ◽  
Anna Ali ◽  
Rehana A. Salam ◽  
Nadeem Zuberi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Pregnant Women ◽  
Low Birthweight ◽  
Meta Analysis ◽  
Perinatal Outcomes ◽  
Respiratory Disorder ◽  
Significant Difference ◽  
The Mean ◽  
In Pregnancy

Abstract Background There is dearth of information on COVID-19’s impact on pregnant women. However, literature reported trends of COVID-19 differ, depending on the presence of clinical features upon presentation. Objective This systematic review aimed to assess differences in risk factors, management, complications, and pregnancy and perinatal outcomes in symptomatic vs. asymptomatic pregnant women with confirmed SARS-CoV-2 infection. Methods A search was run on electronic databases to identify studies reporting COVID-19 in pregnancy. Meta-analysis was performed and odds ratios and mean difference with 95% confidence intervals were calculated using Review Manager 5.4. Review Prospero registration number CRD42020204662. Results We included ten articles reporting data from 3158 pregnancies; with 1900 symptomatic and 1258 asymptomatic pregnant women. There was no significant difference in the mean age, gestational age, and body mass index between the two groups. The meta-analysis suggested that pregnant women who were obese (OR:1.37;95%CI:1.15 to 1.62), hypertensive (OR:2.07;95%CI:1.38 to 3.10) or had a respiratory disorder (OR:1.64;95%CI:1.25 to 2.16), were more likely to be symptomatic when infected with SARS-CoV-2. Pregnant women with Black (OR:1.48;95%CI:1.19 to 1.85) or Asian (OR:1.64;95%CI:1.23 to 2.18) ethnicity were more likely to be symptomatic while those with White ethnicity (OR:0.63;95%CI:0.52 to 0.76) were more likely to be asymptomatic. Cesarean-section delivery (OR:1.40;95%CI:1.17 to 1.67) was more likely amongst symptomatic pregnant women. The mean birthweight(g) (MD:240.51;95%CI:188.42 to 293.51), was significantly lower, while the odds of low birthweight (OR:1.85;95%CI:1.06 to 3.24) and preterm birth (< 37 weeks) (OR:2.10;95%CI:1.04 to 4.23) was higher amongst symptomatic pregnant women. Symptomatic pregnant women had a greater requirement for maternal ICU admission (OR:13.25;95%CI:5.60 to 31.34) and mechanical ventilation (OR:15.56;95%CI:2.96 to 81.70) while their neonates had a higher likelihood for Neonatal Intensive Care Unit admission (OR:1.96;95%CI:1.59 to 2.43). The management strategies in the included studies were poorly discussed, hence could not be analyzed. Conclusion The evidence suggests that the presence of risk factors (co-morbidities and ethnicity) increased the likelihood of pregnant women being symptomatic. Higher odds of complications were also observed amongst symptomatic pregnant women. However, more adequately conducted studies with adjusted analysis and parallel comparison groups are required to reach conclusive findings.

Hazards of vaccination in pregnancy

1973 ◽  
Vol 11 (4) ◽  
pp. 13-15
Keyword(s):  
Pregnant Women ◽  
Yellow Fever ◽  
Early Pregnancy ◽  
First Trimester ◽  
Childbearing Age ◽  
Department Of Health ◽  
Chemical Agents ◽  
Women And Girls ◽  
Yellow Fever Vaccination ◽  
In Pregnancy

With the effects of certain chemical agents and rubella in mind, most authorities advise caution in the use of all vaccines during pregnancy and especially during the first trimester. The booklet issued by the Department of Health and Social Security1 lists pregnancy as a contra-indication to rubella, smallpox and polio vaccinations, with certain provisions, and the manufacturers’ literature adds yellow fever vaccination. Pregnant women wishing to travel obviously pose a problem. Neither the doctor nor the patient may be aware of an early pregnancy and this is always a hazard when vaccinating women and girls of childbearing age. However, apart from rubella and smallpox vaccinations, the risks are hypothetical.

scholarly journals Maternal Coronavirus Infections and Neonates Born to Mothers with SARS-CoV-2: A Systematic Review

Healthcare ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 511
Author(s):  
Waldemar Naves do Amaral ◽  
Carolina Leão de Moraes ◽  
Ana Paula dos Santos Rodrigues ◽  
Matias Noll ◽  
Jalsi Tacon Arruda ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pregnant Women ◽  
Case Reports ◽  
Signs And Symptoms ◽  
Fetal Distress ◽  
Intrauterine Fetal Death ◽  
Fetal Outcomes ◽  
Fetal Movements ◽  
Pregnancy And Delivery ◽  
The Impact

The coronavirus disease 2019 (COVID-19) pandemic is continuously affecting the lives of all people. Understanding the impact of COVID-19 on pregnancy in terms of morbidity, mortality, and perinatal maternal and fetal outcomes is essential to propose strategies for prevention and infection control. Here, we conducted a systematic review to investigate pregnant women infected with COVID-19 in terms of signs and symptoms, type of delivery, comorbidities, maternal and neonatal outcomes, and the possibility of vertical transmission. A search on Embase and PubMed databases was performed on 31 October 2020. Observational studies and case reports on pregnant women infected with COVID-19 were included without language restrictions. The 70 selected studies included a total of 1457 pregnant women diagnosed with COVID-19 in the first, second, and third trimesters of pregnancy. The most common signs and symptoms were fever, cough, and nausea. The most frequent comorbidities were obesity, hypertensive disorders, and gestational diabetes. Among maternal and fetal outcomes, premature birth (n = 64), maternal death (n = 15), intrauterine fetal death or neonatal death (n = 16), cases of intrauterine fetal distress (n = 28), miscarriage (n = 7), decreased fetal movements (n = 19), and severe neonatal asphyxia (n = 5) were the most frequent. Thirty-nine newborns tested positive for SARS-CoV-2. Additionally, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA was detected in the placenta (n = 13) and breast milk (n = 6). This review indicates that COVID-19 during pregnancy can result in maternal, fetal, and neonatal complications. In addition, SARS-CoV-2 viral exposure of neonates during pregnancy and delivery cannot be ruled out. Thus, we highlight the need for long-term follow-up of newborns from mothers diagnosed with COVID-19 to establish the full implications of SARS-CoV-2 infection in these children.

Sign in / Sign up

Export Citation Format

Share Document