scholarly journals Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database

Author(s):  
Maria Hoeltzenbein ◽  
Marie-Louise Lehmann ◽  
Evelin Beck ◽  
Katarina Dathe ◽  
Christof Schaefer

Abstract Purpose Ivabradine has been approved for the treatment of chronic heart failure and chronic stable angina pectoris in Europe. Based on adverse outcomes of reproductive animal studies and the lack of human data, ivabradine is considered contraindicated during pregnancy. The aim of this observational study is to analyse ivabradine use before and during pregnancy. Methods We evaluated all ivabradine-related requests to the German Embryotox Institute from 2007 to 2019. Exposed pregnancies were analysed as to their outcome. Results Off-label use for supraventricular tachycardia was frequent in women of childbearing age. Of 38 prospectively ascertained pregnancies with ivabradine exposure and completed follow-up, 32 resulted in live births, 3 in spontaneous abortions, and 3 were electively terminated. One neonate presented with major birth defects (atrial septal defect and cleft palate). In 33/38 patients, ivabradine was discontinued after confirmation of pregnancy without cardiac deterioration and 5/38 women continued ivabradine throughout pregnancy. In addition, there were 3 retrospectively reported pregnancies including one major birth defect (tracheal atresia). Conclusion This case series represents the largest cohort of ivabradine-exposed pregnancies, published so far. According to our findings, ivabradine appears not to be a major teratogen. However, established drugs of choice with strong evidence of low risk for the unborn should be preferred in women planning pregnancy. After inadvertent exposure during pregnancy or lack of treatment alternatives, fetal ultrasound for structural anomalies and growth restriction is recommended. In addition, close monitoring is necessary in pregnant women with supraventricular arrhythmias or cardiac disease.

2021 ◽  
Author(s):  
Rupalakshmi Vijayan ◽  
Hanna Moon ◽  
Jasmine Joseph ◽  
Madiha Zaidi ◽  
Chhaya Kamwal ◽  
...  

In December 2019, a novel strain of severe acute respiratory syndrome (SARS-CoV-2), was declared as a cause of respiratory illness, called coronavirus 2019 (COVID-19), characterized by fever and cough. In diagnostic imaging, the afflicted population showed pathognomonic findings of pneumonia. What started out as an epidemic in China, rapidly spread across geographical locations with a significant daily increase in the number of affected cases. According to the World Health Organization (WHO) reports, the range of worldwide mortality is 3 to 4%. Maternal adaptations and immunological changes predispose pregnant women to a prolonged and severe form of pneumonia, which results in higher rates of maternal, fetal, and neonatal morbidity and mortality. There is limited data about the consequences of COVID-19 in pregnancy, thereby limiting the prevention, counseling, and management of these patients. The objective of this literature review is to explore pregnancy and perinatal outcomes of COVID-19, complications, morbidity, and mortality in this sub-population. We conducted a literature review pertaining to COVID-19 and pregnancy in databases such as: PubMed, Google Scholar, and Science Direct. The studies we chose to focus on were systematic reviews, meta-analysis, case series, and case reports. Twenty four articles were reviewed regarding COVID-19 and pregnancy, complications and their outcomes. Due to immunological changes during pregnancy as evidenced by the flaring of auto-immune diseases; pregnant women may be at an increased risk for infection. Women (19.7%) who had underlying comorbidities such as gestational DM, HTN, hypothyroidism, and autoimmune disease, COPD, or HBV infection were considered high risk. The most common maternal outcomes were premature rupture of membranes (PROM) and pre-eclampsia. Asthma was the most common comorbidity associated with maternal mortality. The most common neonatal complications were fetal distress leading to NICU admissions and preterm birth <37 weeks. The most common laboratory changes were elevated CRP and lymphocytopenia. Most patients underwent C-section due to their underlying comorbidities. Pregnant and lactating women did not shed viral particles through their vaginal mucus and milk, as evidenced by negative nucleic-acid tests of these secretions. Neonatal infections as demonstrated by positive RT-PCR were rare, but direct evidence supporting intrauterine transmission was not confirmed. Direct evidence indicating vertical transmission of COVID-19 is not available, but risk for transmission cannot be ruled out. Pregnant women should be closely monitored due to increased risk of adverse outcomes.


10.2196/19642 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e19642
Author(s):  
Lijie Wei ◽  
Xuan Gao ◽  
Suhua Chen ◽  
Wanjiang Zeng ◽  
Jianli Wu ◽  
...  

Background Since December 2019, an outbreak of the coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly in Wuhan and worldwide. However, previous studies on pregnant patients were limited. Objective The aim of this study is to evaluate the clinical characteristics and outcomes of pregnant and nonpregnant women with COVID-19. Methods This study retrospectively collected epidemiological, clinical, laboratory, imaging, management, and outcome data of 43 childbearing-age women patients (including 17 pregnant and 26 nonpregnant patients) who presented with laboratory-confirmed COVID-19 in Tongji Hospital, Wuhan, China from January 19 to March 2, 2020. Clinical outcomes were followed up to March 28, 2020. Results Of the 43 childbearing-age women in this study, none developed a severe adverse illness or died. The median ages of pregnant and nonpregnant women were 33.0 and 33.5 years, respectively. Pregnant women had a markedly higher proportion of history exposure to hospitals within 2 weeks before onset compared to nonpregnant women (9/17, 53% vs 5/26, 19%, P=.02) and a lower proportion of other family members affected (4/17, 24% vs 19/26, 73%, P=.004). Fever (8/17, 47% vs 18/26, 69%) and cough (9/17, 53% vs 12/26, 46%) were common onsets of symptoms for the two groups. Abdominal pain (n=4, 24%), vaginal bleeding (n=1, 6%), reduced fetal movement (n=1, 6%), and increased fetal movement (n=2, 13%) were observed at onset in the 17 pregnant patients. Higher neutrophil and lower lymphocyte percent were observed in the pregnant group compared to the nonpregnant group (79% vs 56%, P<.001; 15% vs 33%, P<.001, respectively). In both groups, we observed an elevated concentration of high-sensitivity C-reactive protein, erythrocyte sedimentation rate, aminotransferase, and lactate dehydrogenase. Concentrations of alkaline phosphatase and D-dimer in the pregnant group were significantly higher than those of the nonpregnant group (119.0 vs 48.0 U/L, P<.001; 2.1 vs 0.3μg/mL, P<.001, respectively). Both pregnant (4/10, 40%) and nonpregnant (8/15, 53%) women tested positive for influenza A virus. A majority of pregnant and nonpregnant groups received antiviral (13/17, 76% vs 25/26, 96%) and antibiotic (13/17, 76% vs 23/26, 88%) therapy. Additionally, both pregnant (2/11, 18%) and nonpregnant (2/19, 11%) recovered women redetected positive for SARS-CoV-2 after discharge. Conclusions The epidemiology and clinical and laboratory features of pregnant women with COVID-19 were diverse and atypical, which increased the difficulty of diagnosis. Most pregnant women with COVID-19 were mild and moderate, and rarely developed severe pneumonia or severe adverse outcomes.


2021 ◽  
Vol 10 (8) ◽  
pp. 1562
Author(s):  
Alyssa Ylescupidez ◽  
Aaron Rips ◽  
Henry T. Bahnson ◽  
Cate Speake ◽  
Punam Verma ◽  
...  

Comprehensive data on early prognostic indicators in patients with mild COVID-19 remains sparse. In this single center case series, we characterized the initial clinical presentation in 180 patients with mild COVID-19 and defined the earliest predictors of subsequent deterioration and need for hospitalization. Three broad patient phenotypes and four symptom clusters were characterized, differentiated by varying risk for adverse outcomes. Among 14 symptoms assessed, subjective shortness of breath (SOB) most strongly associated with adverse outcomes (odds ratio (OR) 21.3, 95% confidence interval (CI): 2.7–166.4; p < 0.0001). In combination, SOB and number of comorbidities were highly predictive of subsequent hospitalization (area under the curve (AUC) 92%). Additionally, initial lymphopenia (OR 21.0, 95% CI: 2.1–210.1; p = 0.002) and male sex (OR 3.5, 95% CI: 0.9–13.0; p = 0.05) were associated with increased risk of poor outcomes. Patients with known comorbidities, especially multiple, and those presenting with subjective SOB or lymphopenia should receive close monitoring and consideration for preemptive treatment, even when presenting with mild symptoms.


2017 ◽  
Vol 12 (2) ◽  
pp. 54-57
Author(s):  
Dilruba Zeba ◽  
Parvin Akter Khanam ◽  
Mansur Ahamed ◽  
Md Abul Khair

Iron deficiency is the most common nutritional deficiency state of women in childbearing age. Peri-partum iron deficiency anaemia (IDA) is associated with significant maternal, fetal and infant morbidity. An effective management is needed to prevent adverse outcomes. Current options for treatment are limited; these include oral iron supplements, which are usually ineffective and poorly tolerated, and whole blood transfusion, which carries an inherent risk, should be avoided during pregnancy. Intravenous ferric carboxymaltose is a new treatment option and it is better tolerated with a good result. The study was designed to assess the safety and efficacy of intravenous ferric carboxymaltose for correction of IDA in pregnant women in third trimester. It was a prospective study; 260 anaemic pregnant women received Injection ferric carboxymaltose, as a total dose of 500-1000 mg between 28 to 36 weeks of pregnancy. Safety was assessed by analyzing adverse drug reactions. Ferric carboxy maltose significantly increased Hb level (p<0.001) in all women in this study group. Increased Hb value was observed 3-4 weeks after infusion. None of the women felt worse. No serious adverse effects were found and minor side effects occurred in 34(13%) patients.Our study revealed that the Hb level increased significantly, was well tolerated and without significant side effects.Faridpur Med. Coll. J. Jul 2017;12(2): 54-57


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 362
Author(s):  
Jerome Bouaziz ◽  
Marc Even ◽  
Frederique Isnard-Bogillot ◽  
Eli Vesale ◽  
Mariam Nikpayam ◽  
...  

Coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to escalate worldwide and has become a pressing global health concern. This article comprehensively reviews the current knowledge on the impact of COVID-19 over pregnant women and neonates, as well as current recommendations for their management. We also analyse previous evidences from viral respiratory diseases such as SARS, Middle East respiratory syndrome, and influenza that may help to guide clinical practice during the current pandemic. We collected 23 case reports, case series, and case-control studies (18 from China) comprising 174 pregnant women with COVID-19. The majority of mothers showed a clinical presentation of the disease similar to that of non-infected adults. Preliminary evidences point towards a potentially increased risk of pregnancy adverse outcomes in women with COVID-19, with preterm delivery the most frequently observed (16.7%) followed by fetal distress (9.77%). The most commonly reported adverse neonatal outcomes included respiratory symptoms (7.95%) and low birth weight (6.81%). A few studies reported other maternal comorbidities that can influence these outcomes. Mothers with other comorbidities may be at higher risk of infection. Mother-to-child transmission of SARS-CoV-2 appears unlikely, with no study observing intrauterine transmission, and a few cases of neonatal infection reported a few hours after birth. Although the WHO and other health authorities have published interim recommendations for care and management of pregnant women and infants during COVID-19 pandemic, many questions remain open. Pregnant women should be considered in prevention and control efforts, including the development of drugs and vaccines against SARS-CoV-2. Further research is needed to confirm the exact impact of COVID-19 infection during pregnancy. To fully quantify this impact, we urgently need to integrate the current knowledge about viral characteristics, epidemiology, disease immunopathology, and potential therapeutic strategies with data from the clinical practice.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M R Kirschbaum ◽  
M S Devido ◽  
E Azeka ◽  
L M M F Demarchi ◽  
J S Santos ◽  
...  

Abstract Background Heart disease is the leading non-obstetric cause of maternal death during pregnancy. In this field, the emergence of pandemic COVID-19 has caused the worst-case scenario considering that pregnant women are more susceptible to viral infections, and preexisting cardiac disease is the most prevalent co-morbidity among COVID-19 deaths. Purpose To assess the maternal and fetal outcomes of COVID-19 during pregnancy of women with heart diseases. Methods During the year 2020, among 82 pregnant women with heart disease followed consecutively at the Instituto do Coração-InCor, seven of them with an average age of 33.2 years had COVID-19 during their pregnancies. The underlying heart diseases were rheumatic valve disease (5 pt), congenital heart disease (1 pt) and one case with acute myocarditis, without preexisting cardiopathy. The prescription (antibiotics, inotropes, corticosteroids and others) used was according to the clinical conditions required for each patient, however subcutaneous or intravenous heparin was used in all patients. Results Only one case had an uneventful maternal-fetal course, the other six women required hospitalization / ICU for an average of 25.3 days, including the need for mechanical ventilation in two of them. Serious complications were related to respiratory failure (ADRS), recurrent atrial flutter with hemodynamic instability, acute pulmonary edema, and cardiogenic shock associated with sepsis which caused two maternal deaths. There were two emergency mitral valve interventional, percutaneous balloon valvuloplasty and valve bioprosthesis replacement, respectively. There were five premature births with an average gestational age of 34.2 weeks of gestation, which resulted in one stillbirth. Pathological findings of three placental and the six-months follow-up of the babies did not confirm vertical transmission of COVID-19. Conclusions The uncertain evolution given of the overlapping complications of three conditions – COVID-19, pregnancy, and heart disease – implies an increased risk for women with heart diseases of childbearing age, for whom pregnancy should be discouraged and planned after vaccination FUNDunding Acknowledgement Type of funding sources: None.


Author(s):  
Mile Bosilkovski ◽  
Jurica Arapović ◽  
Fariba Keramat

Human brucellosis during pregnancy is characterized by significantly less pronounced adverse obstetric outcomes than in animals, but with remarkably more adverse obstetric outcomes when compared to healthy pregnant women. Seroprevalence of brucellosis in pregnancy and cumulative incidence of brucellosis cases per 1000 delivered obstetrical discharges in endemic regions were reported to be 1.5–12.2% and 0.42–3.3, respectively. Depending on the region, frequency of pregnant women in the cohorts of patients with brucellosis was from 1.5% to 16.9%. The most common and the most dramatic unfavorable outcomes during brucellosis in pregnancy are the obstetric ones, manifested as abortions (2.5–54.5%), intrauterine fetal death (0–20.6%) or preterm deliveries (1.2–28.6%), depending on the stage of pregnancy. Other unfavorable outcomes due to brucellosis are addressed to infant (congenital/neonatal brucellosis, low birth weight, development delay or even death), the clinical course of disease in mother and delivery team exposure. When diagnosed in pregnant women, brucellosis should be treated as soon as possible. Early administration of adequate therapy significantly reduces the frequency of adverse outcomes. Rifampicin in combination with trimethoprim-sulfamethoxazole for 6 weeks is the most commonly used and recommended regimen, although monotherapies with each of these two drugs are also widely used while waiting for the results from prospective randomized therapeutic trials. As no effective human vaccine exists, screening of pregnant women and education of all women of childbearing age about brucellosis should be compulsory preventive measures in endemic regions.


2020 ◽  
Author(s):  
Lijie Wei ◽  
Xuan Gao ◽  
Suhua Chen ◽  
Wanjiang Zeng ◽  
Jianli Wu ◽  
...  

BACKGROUND Since December 2019, an outbreak of the coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly in Wuhan and worldwide. However, previous studies on pregnant patients were limited. OBJECTIVE The aim of this study is to evaluate the clinical characteristics and outcomes of pregnant and nonpregnant women with COVID-19. METHODS This study retrospectively collected epidemiological, clinical, laboratory, imaging, management, and outcome data of 43 childbearing-age women patients (including 17 pregnant and 26 nonpregnant patients) who presented with laboratory-confirmed COVID-19 in Tongji Hospital, Wuhan, China from January 19 to March 2, 2020. Clinical outcomes were followed up to March 28, 2020. RESULTS Of the 43 childbearing-age women in this study, none developed a severe adverse illness or died. The median ages of pregnant and nonpregnant women were 33.0 and 33.5 years, respectively. Pregnant women had a markedly higher proportion of history exposure to hospitals within 2 weeks before onset compared to nonpregnant women (9/17, 53% vs 5/26, 19%, <i>P</i>=.02) and a lower proportion of other family members affected (4/17, 24% vs 19/26, 73%, <i>P</i>=.004). Fever (8/17, 47% vs 18/26, 69%) and cough (9/17, 53% vs 12/26, 46%) were common onsets of symptoms for the two groups. Abdominal pain (n=4, 24%), vaginal bleeding (n=1, 6%), reduced fetal movement (n=1, 6%), and increased fetal movement (n=2, 13%) were observed at onset in the 17 pregnant patients. Higher neutrophil and lower lymphocyte percent were observed in the pregnant group compared to the nonpregnant group (79% vs 56%, <i>P</i><.001; 15% vs 33%, <i>P</i><.001, respectively). In both groups, we observed an elevated concentration of high-sensitivity C-reactive protein, erythrocyte sedimentation rate, aminotransferase, and lactate dehydrogenase. Concentrations of alkaline phosphatase and D-dimer in the pregnant group were significantly higher than those of the nonpregnant group (119.0 vs 48.0 U/L, <i>P</i><.001; 2.1 vs 0.3μg/mL, <i>P</i><.001, respectively). Both pregnant (4/10, 40%) and nonpregnant (8/15, 53%) women tested positive for influenza A virus. A majority of pregnant and nonpregnant groups received antiviral (13/17, 76% vs 25/26, 96%) and antibiotic (13/17, 76% vs 23/26, 88%) therapy. Additionally, both pregnant (2/11, 18%) and nonpregnant (2/19, 11%) recovered women redetected positive for SARS-CoV-2 after discharge. CONCLUSIONS The epidemiology and clinical and laboratory features of pregnant women with COVID-19 were diverse and atypical, which increased the difficulty of diagnosis. Most pregnant women with COVID-19 were mild and moderate, and rarely developed severe pneumonia or severe adverse outcomes.


2018 ◽  
Author(s):  
Sylvia Roozen ◽  
Gjalt - Jorn Ygram Peters ◽  
Gerjo Kok ◽  
Leopold Curfs

BackgroundFetal Alcohol Spectrum Disorders (FASD) is an important global health problem in need of prevention. For FASD prevention it is important to understand why pregnant women engage or do not engage in drinking alcohol. It remains unknown which psychosocial determinants related to maternal alcohol consumption are most in need of prevention. The objective of this study was to identify these.MethodWe searched in PubMed, PsychINFO, PsychARTICLES, ERIC, CINAHL, EMBASE and MEDLINE databases up to May 2018 using an extensive query consisting of keywords related to pregnancy (e.g., maternal, prenatal), alcohol use (e.g., alcohol, drink) and determinants (e.g., attitude, norm). Studies were excluded when not published in English, were reviews, or involved non-human subjects. Substantial heterogeneity precluded aggregation or meta-analysis of the data. Instead, data were qualitatively inspected.ResultsA total of 23 studies including 150 identified items were eligible for data analysis. Studies covered over 15 psychosocial determinants (e.g., attitude, perceived social norm, risk perception). Studies differed in their operationalizations. As a majority of data was based on univariate analysis, little is known about the relationship with specific drinking behaviors. The majority of studies targeted perceived risk and motivation to comply with each social referents' approval or disapproval. A large proportion of studies focused on disadvantages and risks of maternal alcohol consumption. Results from these studies show that women do not continue to drink because the risks are unknown to them. Cautious interpretation is needed while the observed heterogeneity hindered firm conclusions. Conclusion We aimed to identify all relevant psychosocial determinants of maternal alcohol consumption behavior(s). The state of the literature precludes such conclusions. It remains unknown which determinants are most in need of intervention. It is recommended for future studies to (i) identify all possible psychosocial determinants of drinking during pregnancy using both quantitative and qualitative methods; (ii) include different target groups (e.g., women with unplanned pregnancies, pregnant women, women in childbearing age); (iii) identify key environmental agents; (iv) operationalize their measures based on theoretical models; (v) report specific variables such as the study method and association with behavior.


2019 ◽  
Vol 15 (2) ◽  
pp. 143-149 ◽  
Author(s):  
Harpriya Kaur ◽  
Delf Schmidt-Grimminger ◽  
Baojiang Chen ◽  
K.M. Monirul Islam ◽  
Steven W. Remmenga ◽  
...  

Background: Pregnancy may increase the risk of Human Papillomavirus (HPV) infection because of pregnancy induced immune suppression. The objective of this study was to use a large population-based dataset to estimate the prevalence of HPV infection and its association with adverse outcomes among pregnant women. Methods: We analyzed Pregnancy Risk Monitoring System data from 2004-2011 (N=26,085) to estimate the self-reported HPV infection. Survey logistic procedures were used to examine the relationship between HPV infection and adverse perinatal outcomes. Results: Approximately 1.4% of women were estimated to have HPV infection during their pregnancy. The prevalence of adverse outcomes in this sample was preterm birth (8.4%), preeclampsia (7.5%), low birth weight (6.3%) and premature rupture of membranes (2.8%). Compared to women without HPV infection, HPV infection positive women were much more likely to have had other infections such as chlamydia (9.23% vs. 2.12%, p-value <.0001), Group B Strep (21.7% vs. 10.04%, p-value <.0001), and herpes (7.17% vs. 1.07%, p-value <.0001). After adjusting for other risk factors including other infections, HPV infection was significantly associated with low birth weight (OR: 1.94, 95% CI: 1.14-3.30). Conclusion: The study indicated a potential association between HPV infection and low birth weight. Because pregnant women with HPV infection are at higher risk of other infections, future research may focus on the roles of co-infection in the development of adverse perinatal effects.


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