scholarly journals #49: Management and Outcomes of Infants Born to Mothers with SARS-CoV-2 Infection in Pregnancy

2021 ◽  
Vol 10 (Supplement_2) ◽  
pp. S15-S15
Author(s):  
Sebastian Otero ◽  
Allaa Fadl-Alla ◽  
Malika D Shah ◽  
Allison Sakowicz ◽  
Chiedza Mupanomunda ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Acute Infection ◽  
Safety Data ◽  
Clinical History ◽  
Policy Changes ◽  
Infant Outcomes ◽  
Previous Infection ◽  
Asymptomatic Infant ◽  
In Pregnancy

Abstract Background SARS-CoV-2 infections during pregnancy continue in this ongoing pandemic. Care of mother-infant dyads affected by SARS-CoV-2 infection in pregnancy has evolved. Perinatal viral transmission is rare. However, there remain few detailed reports on characteristics and management of these infants during neonatal hospitalization. Our objective was to investigate management and outcomes of infants born to women with laboratory-confirmed SARS-CoV-2 infection in pregnancy including resuscitation, NICU care, separation, and breastfeeding. Methods This is a study of mother-infant dyads with SARS-CoV-2 in pregnancy at Prentice Women’s Hospital in Chicago, IL (3/2020-11/2020). Dyads were tracked prospectively with data obtained by review of electronic medical records including demographics, maternal clinical history, COVID symptoms, and neonatal course. Women were universally screened with SARS-CoV-2 PCR at admission. Mothers were categorized as 1) acute infection (-14–0 days from delivery) vs. previous infection (>14 days), and 2) symptomatic vs. asymptomatic (defined by CDC criteria). Infants of mothers with acute infection were tested for SARS-CoV-2. Results We report a diverse cohort of 210 women with SARS-CoV-2 in pregnancy, 114 acute and 96 previous infection (range 0–229 days between positive PCR and delivery) [Table 1]. Over half (56%) of women were symptomatic, 29/114 (25%) with acute infection, 89/96 (93%) with previous infection. Of 211 infants, one asymptomatic infant tested positive for SARS-CoV-2. The overall rate of preterm birth was 10.9% in this cohort. The rate of preterm birth was 26.6% (8/30) in the symptomatic acute infection group (p=0.055) and birthweight was significantly lower (p=0.03). There was no apparent increased need for resuscitation at delivery. APGARs were 8 (8–9) and 9 (8–9) at 1 and 5 minutes, respectively. Six percent of infants >35 weeks had respiratory distress. About 7% had failed hearing screen (historic Prentice rate ~4%). Separation of infants from mothers with acute infection decreased over time due to policy changes based on available safety data for rooming in (Cuzick’s test for trend p<0.001). Most infants (75%) received breastmilk in the hospital over this timeframe; this was low initially and increased over this timeframe (p<0.001). For example, 45% of mothers with acute infection provided breastmilk in May compared to nearly 100% in November. Twelve women were diagnosed with chorioamnionitis due to fever in labor and also had acute SARS-CoV-2 infection. Conclusion Infants of mothers with SARS-CoV-2 in pregnancy had favorable short-term outcomes, with decrease in separation and increase in breastfeeding over this timeframe. Complex factors likely contribute to differences in birthweight and prematurity in the acute symptomatic group. Isolated fever in the setting of acute SARS-CoV-2 presents a dilemma regarding maternal chorioamnionitis, resulting in antibiotic exposure. Longitudinal follow-up is needed to determine infant outcomes (true hearing loss, development) following maternal SARS-CoV-2 infection.

scholarly journals Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials

2019 ◽  
Author(s):  
Noel Patson ◽  
Mavuto Mukaka ◽  
Kennedy N Otwombe ◽  
Lawrence Kazembe ◽  
Don P Mathanga ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Missing Data ◽  
Drug Safety ◽  
Safety Data ◽  
Malaria Prevention ◽  
Antimalarial Drugs ◽  
Controlled Trials ◽  
Safety Outcomes ◽  
In Pregnancy

Abstract Background Drug safety assessments in clinical trials present unique analytical challenges. Some of these include adjusting for individual follow-up time, repeated measurements of multiple outcomes and missing data among others. Furthermore, pre-specifying appropriate analysis becomes difficult as some safety endpoints are unexpected. Although existing guidelines such as CONSORT encourage thorough reporting of adverse events (AEs) in clinical trials, they provide limited details for safety data analysis. The limited guidelines may influence suboptimal analysis by failing to account for some analysis challenges above. A typical example where such challenges exist are trials of antimalarial drugs for malaria prevention during pregnancy. Lack of proper standardized evaluation of the safety of antimalarial drugs has limited the ability to draw conclusions about safety. We have therefore conducted a systematic review to establish the current practice in statistical analysis for antimalarial drug safety in pregnancy.Methods We searched PubMed, Embase, Scopus, Malaria in Pregnancy Library and Cochrane Central Register of Controlled Trials for original English articles reporting Phase III (randomized controlled trials) RCTs on antimalarial drugs for malaria prevention in pregnancy published from January 2010 to July 2019.Results Eighteen trials were included in this review that collected multiple longitudinal safety outcomes including AEs. Statistical analysis and reporting of the safety outcomes in all the trials used descriptive statistics; proportions/counts (n=18, 100%) and mean/median (n=2, 11.1%). Results presentation included tabular (n=16, 88.9%) and text description (n=2, 11.1%). Univariate inferential methods were reported in most trials (n=16, 88.9%); including Chi-square/Fisher`s exact test (n=12, 66.7%), t-test (n=2, 11.1%) and Mann-Whitney/Wilcoxon test (n=1, 5.6%). Multivariable methods, including Poisson and negative binomial were reported in few trials (n=4, 22.2%). Assessment of a potential link between missing efficacy data and safety outcomes was not reported in any of the trials that reported efficacy missing data (n=7, 38.9%).Conclusion The review demonstrated that statistical analysis of safety data in antimalarial drugs for malarial chemoprevention in pregnancy RCTs are inadequate. The analysis insufficiently account for multiple safety outcomes potential dependence, follow-up time and informative missing data which can compromise antimalarial drug safety evidence development, based on the available data.

Abstract P188: Preterm Birth is a Predictor of Future Maternal Intima Medial Thickness: The CARDIA Study

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Janet M Catov ◽  
Cora E Lewis ◽  
Minjae Lee ◽  
Patrick R Ramsey ◽  
Melissa F Wellons ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Preterm Birth ◽  
Coronary Artery ◽  
Inflammatory Markers ◽  
Excess Risk ◽  
Hypertension In Pregnancy ◽  
Term Births ◽  
Intima Medial Thickness ◽  
In Pregnancy

Introduction: Preterm birth (PTB, delivery <37 weeks) may be a marker of a chronic pro- inflammatory response associated with excess risk of coronary artery disease. Hypothesis: We hypothesized that women with PTB would have elevated blood pressure, markers of inflammation (C-reactive protein [CRP], Interleukin-6 [IL-6]) as well as higher intima medial thickness (IMT) in the years following pregnancy. Further, we considered that these differences would persist after removing PTB cases due to self-reported hypertensive disorders of pregnancy (primary reason for indicated PTB). Methods: We studied 916 women (46% Black) who delivered 1,181 live births between enrollment in the Coronary Artery Risk Development in Young Adults (CARDIA) study (age 18-30 years) and 20 years later (age 38-50 years). CRP was measured at years 7, 15 and 20; IL-6 and common carotid IMT (average of the maximum wall thickness of the respective carotid artery segment based on 4 ultrasonic measurements for the common carotid arteries) were measured at year 20. Blood pressure, lipids, and anthropometrics were measured at baseline and 6 follow-up visits. Median concentrations of inflammatory markers and mean IMT were compared in women with and without a history of PTB. Change in blood pressure, lipids, body size and CRP concentrations according to PTB status was also evaluated using generalized estimating equations (GEE). Results: A total of 226 women (24.7%) reported at least one PTB. Women with PTBs had modestly higher pre-pregnancy systolic blood pressure (SBP) compared to women who delivered term births (106.3 vs. 104.9 mmHg, p=0.02); SBP was higher across follow-up (p=0.03 for group differences) and increased more rapidly over 20 years compared to women with term births (p<0.01 for group*time interaction). These differences remained significant after removal of women with hypertension in pregnancy. Women with PTB had modestly higher mean body mass index (BMI) at baseline, and differences were more robust beginning in year 7 of follow up. Compared to women with term births, women with PTB had borderline higher mean IMT at year 20, adjusted for age and BMI (difference=0.016 mm, p=0.06). Adjustment for blood pressure change from baseline to year 20 did not affect the estimate. Adjustment for race attenuated this difference (p=0.33), and after excluding women with self-reported hypertension in pregnancy IMT no longer differed by PTB status. CRP, IL-6 and lipids did not differ according to PTB status. Conclusion: Women with PTBs, regardless of hypertension during pregnancy, had higher blood pressure before pregnancy and in the two decades after pregnancy compared to women with term births. They also higher mean IMTs, explained in part by race. Differences in IMT may be limited to women who reported hypertension in pregnancy, and were not related to inflammatory markers. PTB may mark women at excess risk of atherosclerosis.

scholarly journals Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials

2020 ◽  
Author(s):  
Noel Patson ◽  
Mavuto Mukaka ◽  
Kennedy N Otwombe ◽  
Lawrence Kazembe ◽  
Don P Mathanga ◽  
...  
Keyword(s):  
Systematic Review ◽  
Statistical Analysis ◽  
Missing Data ◽  
Drug Safety ◽  
Safety Data ◽  
Malaria Prevention ◽  
Controlled Trials ◽  
Safety Outcomes ◽  
In Pregnancy

Abstract Background Drug safety assessments in clinical trials present unique analytical challenges. Some of these include adjusting for individual follow-up time, repeated measurements of multiple outcomes and missing data among others. Furthermore, pre-specifying appropriate analysis becomes difficult as some safety endpoints are unexpected. Although existing guidelines such as CONSORT encourage thorough reporting of adverse events (AEs) in clinical trials, they provide limited details for safety data analysis. The limited guidelines may influence suboptimal analysis by failing to account for some analysis challenges above. A typical example where such challenges exist are trials of anti-malarial drugs for malaria prevention during pregnancy. Lack of proper standardized evaluation of the safety of antimalarial drugs has limited the ability to draw conclusions about safety. Therefore, a systematic review was conducted to establish the current practice in statistical analysis for preventive antimalarial drug safety in pregnancy. Methods The search included five databased (PubMed, Embase, Scopus, Malaria in Pregnancy Library and Cochrane Central Register of Controlled Trials) to identify original English articles reporting Phase III randomized controlled trials (RCTs) on anti-malarial drugs for malaria prevention in pregnancy published from January 2010 to July 2019. Results Eighteen trials were included in this review that collected multiple longitudinal safety outcomes including AEs. Statistical analysis and reporting of the safety outcomes in all the trials used descriptive statistics; proportions/counts (n=18, 100%) and mean/median (n=2, 11.1%). Results presentation included tabular (n=16, 88.9%) and text description (n=2, 11.1%). Univariate inferential methods were reported in most trials (n=16, 88.9%); including Chi-square/Fisher`s exact test (n=12, 66.7%), t-test (n=2, 11.1%) and Mann-Whitney/Wilcoxon test (n=1, 5.6%). Multivariable methods, including Poisson and negative binomial were reported in few trials (n=4, 22.2%). Assessment of a potential link between missing efficacy data and safety outcomes was not reported in any of the trials that reported efficacy missing data (n=7, 38.9%). Conclusion The review demonstrated that statistical analysis of safety data in anti-malarial drugs for malarial chemoprevention in pregnancy RCTs is inadequate. The analyses insufficiently account for multiple safety outcomes potential dependence, follow-up time and informative missing data which can compromise anti-malarial drug safety evidence development, based on the available data.

scholarly journals Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials

2020 ◽  
Author(s):  
Noel Patson ◽  
Mavuto Mukaka ◽  
Kennedy N Otwombe ◽  
Lawrence Kazembe ◽  
Don P Mathanga ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Missing Data ◽  
Drug Safety ◽  
Safety Data ◽  
Malaria Prevention ◽  
Antimalarial Drugs ◽  
Controlled Trials ◽  
Safety Outcomes ◽  
In Pregnancy

Abstract Background Drug safety assessments in clinical trials present unique analytical challenges. Some of these include adjusting for individual follow-up time, repeated measurements of multiple outcomes and missing data among others. Furthermore, pre-specifying appropriate analysis becomes difficult as some safety endpoints are unexpected. Although existing guidelines such as CONSORT encourage thorough reporting of adverse events (AEs) in clinical trials, they provide limited details for safety data analysis. The limited guidelines may influence suboptimal analysis by failing to account for some analysis challenges above. A typical example where such challenges exist are trials of antimalarial drugs for malaria prevention during pregnancy. Lack of proper standardized evaluation of the safety of antimalarial drugs has limited the ability to draw conclusions about safety. We have therefore conducted a systematic review to establish the current practice in statistical analysis for antimalarial drug safety in pregnancy. Methods We searched PubMed, Embase, Scopus, Malaria in Pregnancy Library and Cochrane Central Register of Controlled Trials for original English articles reporting Phase III (randomized controlled trials) RCTs on antimalarial drugs for malaria prevention in pregnancy published from January 2010 to July 2019. Results Eighteen trials were included in this review that collected multiple longitudinal safety outcomes including AEs. Statistical analysis and reporting of the safety outcomes in all the trials used descriptive statistics; proportions/counts (n=18, 100%) and mean/median (n=2, 11.1%). Results presentation included tabular (n=16, 88.9%) and text description (n=2, 11.1%). Univariate inferential methods were reported in most trials (n=16, 88.9%); including Chi-square/Fisher`s exact test (n=12, 66.7%), t-test (n=2, 11.1%) and Mann-Whitney/Wilcoxon test (n=1, 5.6%). Multivariable methods, including Poisson and negative binomial were reported in few trials (n=4, 22.2%). Assessment of a potential link between missing efficacy data and safety outcomes was not reported in any of the trials that reported efficacy missing data (n=7, 38.9%). Conclusion The review demonstrated that statistical analysis of safety data in antimalarial drugs for malarial chemoprevention in pregnancy RCTs are inadequate. The analysis insufficiently account for multiple safety outcomes potential dependence, follow-up time and informative missing data which can compromise antimalarial drug safety evidence development, based on the available data.

Ischemic Complications of Pregnancy: Who is at Risk?

2016 ◽  
Vol 10 (1) ◽  
pp. 14
Author(s):  
Sara C Martinez ◽  
◽  
Sharonne N Hayes ◽  
Keyword(s):  
Artery Dissection ◽  
Cardiac Events ◽  
Coronary Artery Dissection ◽  
Reduction Strategies ◽  
Ischemic Complications ◽  
Substantial Risk ◽  
History Of ◽  
Invasive Management ◽  
In Pregnancy

The physiologic demands of pregnancy may either trigger or uncover ischemic heart disease (IHD) via largely unknown mechanisms, leading to an increased mortality compared with nonpregnant individuals. Risk factors for IHD in pregnancy are age, smoking, multiparity, and prior cardiac events. A multidisciplinary team at a referral center is key to coordinating medical or invasive management and inpatient observation. Etiologies may be revealed by experienced angiographers, and are predominantly spontaneous coronary artery dissection, followed by atherosclerotic disease and thrombus, while a significant percentage of women are found to have normal coronary arteries by angiogram. The management of these conditions is varied and, in general, conservative management is preferred with adequate coronary flow and stable hemodynamics. A woman with a history of IHD in pregnancy is at a substantial risk for further complications in future pregnancies and beyond; therefore, aggressive risk factor-reduction strategies and regular cardiology follow-up are imperative to decrease adverse events.

Neurological manifestation in severe hypothyroidism in pregnancy

2020 ◽  
Vol 13 (12) ◽  
pp. e238069
Author(s):  
Aparna Sharma ◽  
Nilofar Noor ◽  
Vatsla Dadhwal
Keyword(s):  
Peripheral Neuropathy ◽  
Facial Palsy ◽  
Caesarean Delivery ◽  
Thyroid Stimulating Hormone ◽  
Neurological Manifestations ◽  
Second Trimester ◽  
Pituitary Hyperplasia ◽  
Very High ◽  
In Pregnancy

Neurological manifestations of hypothyroidism include peripheral neuropathy and pituitary hyperplasia. However, these associations are rarely encountered during pregnancy. We report a case of a known hypothyroid with very high thyroid stimulating hormone (TSH) values (512 μIU/mL) in the second trimester. At 24 weeks she developed facial palsy and pituitary hyperplasia which responded to a combination of steroids and thyroxine. She had caesarean delivery at 35 weeks and 3 days gestation in view of pre-eclampsia with severe features and was discharged on oral antihypertensives and thyroxine. On follow-up at 5 months, TSH normalised and pituitary hyperplasia showed a greater than 50% reduction in size. To our knowledge, this is the first reported case of facial palsy and pituitary hyperplasia associated with hypothyroidism during pregnancy.

scholarly journals Impacts of Faith-Based Lifestyle Interventions on Congregational-Level Nutrition and Physical Activity Environment and Policies

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 300-300
Author(s):  
Summer Wilmoth ◽  
Leah Carrillo ◽  
Elana Martinez ◽  
Raymundo Mendoza Mendoza ◽  
Lauren Correa ◽  
...  
Keyword(s):  
Physical Activity ◽  
Program Effectiveness ◽  
San Antonio ◽  
Macro Level ◽  
Policy Changes ◽  
Environment Policy ◽  
Post Hoc Analysis ◽  
Faith Based ◽  
Post Hoc

Abstract Objectives Hispanics are disproportionally affected by obesity, cancer, and other obesity-related chronic diseases. Building a Healthy Temple (BHT) was a multi-component, faith-based lifestyle intervention implemented in 27 low-income, predominately-Hispanic congregations in San Antonio, TX between 2012 and 2017. One aim of BHT was to assess program effectiveness at improving health-conducive church environment/policy and sustainability of these improvements at follow-up. Methods A key macro-level program component of BHT was the formation of a Health Ministry Committee to initiate church-wide health-conducive environment/policy changes. The Congregational Health Index (CHI) was used to assess church nutrition (17 items) and physical activity (PA, 5 items) environment/policy at baseline, end of program, and follow-up (6 months or more post-intervention). Data were expressed as % of the maximum scores. Friedman test and post hoc analysis were performed with Wilcoxon signed-rank tests and significance of pairwise comparisons, adjusted with Bonferroni correction. Results Eighteen churches completed all 3 CHI assessments. Percentage of total nutrition and PA environment/policy scores for baseline, end of program, and follow-up were 38% (35–45), 64% (53–75), and 69% (64–77), respectively. Post hoc analysis shows significant improvements in nutrition and PA environment/policy scores at end of program (Z = –3.73, P &lt; 0.001) and follow-up (Z = –3.73, P &lt; 0.001) as compared to baseline, as well as significantly higher scores at follow-up compared to end of program (Z = –3.18, P = 0.001). Conclusions Study findings reveal the importance of utilizing congregation-wide macro-level interventions to create health-conducive enviroment/policy changes to facilitate and sustain healthy lifestyle changes in predominately-Hispanic faith community settings. Funding Sources Baptist Health Foundation San Antonio & Cancer Prevention Research Institute of Texas.

scholarly journals Factors associated with preterm birth at Wachemo University Nigist Eleni Mohammed memorial hospital, southern Ethiopia: case-control study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Negeso Gebeyehu Gejo ◽  
Melaku Tesfaye W/mariam ◽  
Biruk Assefa Kebede ◽  
Ritbano Ahmed Abdo ◽  
Abebe Alemu Anshebo ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Antenatal Care ◽  
Medical Records ◽  
Case Control Study ◽  
Southern Ethiopia ◽  
Preterm Neonates ◽  
Factors Associated ◽  
Induced Hypertension ◽  
Control Study

Abstract Background Preterm birth is defined as the birth of a baby before 37 completed weeks of gestation. Worldwide, prematurity is the second foremost cause of death in children under the age of 5 years. Preterm birth also gives rise to short and long term complications. Therefore, the primary aim of this study was to identify the factors associated with preterm birth in Wachemo University Nigist Eleni Mohammed Memorial referral hospital, Hadiya Zone, Southern Ethiopia. Methods An institution-based unmatched case-control study was conducted from July 01, 2018 to June 30, 2019 among mothers who gave birth in Wachemo University Nigest Eleni Mohammed Memorial referral hospital. A retrospective one-year data was retrieved from medical records of mothers with their index neonates. Simple random sampling technique was employed to recruit study participants. SPSS version 20 software was used for data entry and computing statistical analysis. Both bivariable and multivariable logistic regression analyses were used to determine the association of each independent variable with the dependent variable. Odds ratio with their 95% confidence intervals was computed to identify the presence and strength of association, and statistical significance was affirmed if p < 0.05. Result The current study evaluated 213 medical records of mothers with index neonates (71 cases and 142 controls). Urban residency [AOR = 0.48; 95% Cl; 0.239, 0.962], antenatal care follow up [AOR = 0.08; 95 Cl; 0.008, 0.694], premature rupture of membranes [AOR = 3.78; 95% Cl; 1.467, 9.749], pregnancy induced hypertension [AOR = 3.77; 95% Cl; 1.408, 10.147] and multiple pregnancies [AOR = 5.53; 95% Cl; 2.467, 12.412] were the factors associated with preterm birth. More than one-third (36.6%) preterm neonates died in the present study. Conclusions The present study found that urban residency, antenatal care follow up, premature rupture of membranes, pregnancy induced hypertension and multiple pregnancies were factors associated with preterm birth. The mortality among preterm neonates is high. Enhancing antenatal care follow up and early detection and treatment of disorders among pregnant women during antenatal care and undertaking every effort to improve outcomes of preterm birth and reduce neonatal mortality associated with prematurity is decisive.

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