Fetal safety of magnetic resonance imaging (MRI) during the first trimester of pregnancy or with gadolinium enhancement at any time of pregnancy is unknown.
To evaluate the long-term safety after ...exposure to MRI in the first trimester of pregnancy or to gadolinium at any time during pregnancy.
Universal health care databases in the province of Ontario, Canada, were used to identify all births of more than 20 weeks, from 2003-2015.
Magnetic resonance imaging exposure in the first trimester of pregnancy, or gadolinium MRI exposure at any time in pregnancy.
For first-trimester MRI exposure, the risk of stillbirth or neonatal death within 28 days of birth and any congenital anomaly, neoplasm, and hearing or vision loss was evaluated from birth to age 4 years. For gadolinium-enhanced MRI in pregnancy, connective tissue or skin disease resembling nephrogenic systemic fibrosis (NSF-like) and a broader set of rheumatological, inflammatory, or infiltrative skin conditions from birth were identified.
Of 1 424 105 deliveries (48% girls; mean gestational age, 39 weeks), the overall rate of MRI was 3.97 per 1000 pregnancies. Comparing first-trimester MRI (n = 1737) to no MRI (n = 1 418 451), there were 19 stillbirths or deaths vs 9844 in the unexposed cohort (adjusted relative risk RR, 1.68; 95% CI, 0.97 to 2.90) for an adjusted risk difference of 4.7 per 1000 person-years (95% CI, -1.6 to 11.0). The risk was also not significantly higher for congenital anomalies, neoplasm, or vision or hearing loss. Comparing gadolinium MRI (n = 397) with no MRI (n = 1 418 451), the hazard ratio for NSF-like outcomes was not statistically significant. The broader outcome of any rheumatological, inflammatory, or infiltrative skin condition occurred in 123 vs 384 180 births (adjusted HR, 1.36; 95% CI, 1.09 to 1.69) for an adjusted risk difference of 45.3 per 1000 person-years (95% CI, 11.3 to 86.8). Stillbirths and neonatal deaths occurred among 7 MRI-exposed vs 9844 unexposed pregnancies (adjusted RR, 3.70; 95% CI, 1.55 to 8.85) for an adjusted risk difference of 47.5 per 1000 pregnancies (95% CI, 9.7 to 138.2).
Exposure to MRI during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood. Gadolinium MRI at any time during pregnancy was associated with an increased risk of a broad set of rheumatological, inflammatory, or infiltrative skin conditions and for stillbirth or neonatal death. The study may not have been able to detect rare adverse outcomes.
Objective To develop a practical evidence based list of clinical risk factors that can be assessed by a clinician at ≤16 weeks’ gestation to estimate a woman’s risk of pre-eclampsia.Design Systematic ...review and meta-analysis of cohort studies.Data sources PubMed and Embase databases, 2000-15.Eligibility criteria for selecting studies Cohort studies with ≥1000 participants that evaluated the risk of pre-eclampsia in relation to a common and generally accepted clinical risk factor assessed at ≤16 weeks’ gestation.Data extraction Two independent reviewers extracted data from included studies. A pooled event rate and pooled relative risk for pre-eclampsia were calculated for each of 14 risk factors.Results There were 25 356 688 pregnancies among 92 studies. The pooled relative risk for each risk factor significantly exceeded 1.0, except for prior intrauterine growth restriction. Women with antiphospholipid antibody syndrome had the highest pooled rate of pre-eclampsia (17.3%, 95% confidence interval 6.8% to 31.4%). Those with prior pre-eclampsia had the greatest pooled relative risk (8.4, 7.1 to 9.9). Chronic hypertension ranked second, both in terms of its pooled rate (16.0%, 12.6% to 19.7%) and pooled relative risk (5.1, 4.0 to 6.5) of pre-eclampsia. Pregestational diabetes (pooled rate 11.0%, 8.4% to 13.8%; pooled relative risk 3.7, 3.1 to 4.3), prepregnancy body mass index (BMI) >30 (7.1%, 6.1% to 8.2%; 2.8, 2.6 to 3.1), and use of assisted reproductive technology (6.2%, 4.7% to 7.9%; 1.8, 1.6 to 2.1) were other prominent risk factors.Conclusions There are several practical clinical risk factors that, either alone or in combination, might identify women in early pregnancy who are at “high risk” of pre-eclampsia. These data can inform the generation of a clinical prediction model for pre-eclampsia and the use of aspirin prophylaxis in pregnancy.
To determine the impact of pre-pregnancy diabetes mellitus (D), obesity (O) and chronic hypertension (H) on preterm birth (PTB).
Retrospective population-based cohort study in Ontario, Canada between ...2012-2016. Women who had a singleton livebirth or stillbirth at > 20 weeks gestation were included in the cohort. Exposures of interest were D, O and H, individually, and in various combinations. The primary outcome was PTB at 241/7 to 366/7 weeks. PTB was further analyzed by spontaneous or provider-initiated, early (< 34 weeks) or late (34-37 weeks), and the co-presence of preeclampsia, large for gestational age (LGA), and small for gestational age (SGA). Multivariable Poisson regression models with robust error variance were used to generate relative risks (RR), further adjusted for maternal age and parity (aRR). Population attributable fractions (PAF) were calculated for each of the outcomes by exposure state.
506,483 women were eligible for analysis. 30,139 pregnancies (6.0%) were complicated by PTB < 37 weeks, of which 7375 (24.5%) had D or O or H. Relative to women without D or O or H, the aRR for PTB < 37 weeks was higher for D (3.51; 95% CI 3.26-3.78) and H (3.81; 95% CI 3.55-4.10) than O (1.14; 95% CI 1.10-1.17). The combined state of DH was associated with a significantly higher aRR of PTB < 37 weeks (6.34; 95% CI 5.14-7.80) and < 34 weeks (aRR 10.33, 95% CI 6.96-15.33) than D alone. The risk of provider initiated PTB was generally higher than that for spontaneous PTB. Pre-pregnancy hypertension was associated with the highest risk for PTB with preeclampsia (aRR 45.42, 95% CI 39.69-51.99) and PTB with SGA (aRR 9.78, 95% CI 7.81-12.26) while pre-pregnancy diabetes was associated with increased risk for PTB with LGA (aRR 28.85, 95% CI 24.65-33.76).
Combinations of DOH significantly magnify the risk of PTB, especially provider initiated PTB, and PTB with altered fetal growth or preeclampsia.
Latent class analysis (LCA) offers a powerful analytical approach for categorizing groups (or “classes”) within a heterogenous population. LCA identifies these hidden classes by a set of predefined ...features, known as “indicators”. Unlike many other grouping analytical approaches, LCA derives classes using a probabilistic approach. In this first paper, we describe the common applications of LCA, and outline its advantages over other analytical subgrouping methods.
Few researchers have evaluated neonatal mortality in the combined presence of preterm birth (PTB) and small-for-gestational age (SGA) birth weight. None differentiated between infants with and ...without anomalies, considered births starting at 23 weeks' gestation, or defined SGA at a more pathologic cutpoint less than the fifth percentile.
We completed a population-based cohort study within the province of Ontario, Canada, from 2002 to 2015. Included were 1 676 110 singleton hospital live births of 23 to 42 weeks' gestation. Modified Poisson regression compared rates and relative risks of neonatal mortality among those with (1) preterm birth at 23 to 36 weeks' gestation and concomitant severe small for gestational age (PTB-SGA), (2) PTB at 23 to 36 weeks' gestation without severe SGA, (3) term birth with severe SGA, and each relative to (4) neither. Relative risks were adjusted for maternal age and stratified by several demographic variables.
Relative to a neonatal mortality rate of 0.6 per 1000 term infants without severe SGA, the rate was 2.8 per 1000 among term births with severe SGA (adjusted relative risk aRR 4.6; 95% confidence interval CI 4.0-5.4), 22.9 per 1000 for PTB without severe SGA (aRR 38.3; 95% CI 35.4-41.4) and 60.0 per 1000 for PTB-SGA (aRR 96.7; 95% CI 85.4-109.5). Stratification by demographic factors showed a persistence of this pattern of neonatal death. Restricting the sample to births at ≥24 weeks' gestation, or newborns without a congenital or chromosomal anomaly, also demonstrated the same pattern.
Methods to detect or prevent PTB or SGA should focus on PTB-SGA, which serves as a useful perinatal surveillance indicator.
Latent class analysis (LCA) is an analytical approach for the identification of more homogeneous subgroups within an otherwise dissimilar patient population. In the current paper, Part II, we present ...a practical step-by-step guide for LCA of clinical data, including when LCA might be applied, selecting indicator variables, and choosing a final class solution. We also identify common pitfalls of LCA, and related solutions.
Latent Class Analysis (LCA) is an analytical approach for the identification of more homogeneous subgroups within an otherwise dissimilar patient population. In the current paper, Part II, we present ...a practical step-by-step guide for LCA of clinical data, including when LCA might be applied, selecting indicator variables, and choosing a final class model. We also identify some common pitfalls of LCA, and some related solutions.
Prior studies comparing first-trimester pharmaceutical induced abortion (IA) with procedural IA were prone to selection bias, were underpowered to assess serious adverse events (SAEs), and did not ...account for confounding by indication. Starting in 2017, mifepristone-misoprostol was dispensed at no cost in outpatient pharmacies across Ontario, Canada.
To compare short-term risk for adverse outcomes after early IA by mifepristone-misoprostol versus by procedural IA.
Population-based cohort study.
Ontario, Canada.
All women who had first-trimester IA.
A total of 39 856 women dispensed mifepristone-misoprostol as outpatients were compared with 65 176 women undergoing procedural IA at 14 weeks' gestation or earlier within nonhospital outpatient clinics (comparison 1). A total of 39 856 women prescribed mifepristone-misoprostol were compared with 8861 women undergoing ambulatory hospital-based procedural IA at an estimated 9 weeks' gestation or less (comparison 2). The primary composite outcome was any SAE within 42 days after IA, including severe maternal morbidity, end-organ damage, intensive care unit admission, or death. A coprimary broader outcome comprised any SAE, hemorrhage, retained products of conception, infection, or transfusion. Stabilized inverse probability of treatment weighting accounted for confounding between exposure groups.
Mean age at IA was about 29 years (SD, 7); 33% were primigravidae. Six percent resided in rural areas, and 25% resided in low-income neighborhoods. In comparison 1, SAEs occurred among 133 women after mifepristone-misoprostol IA (3.3 per 1000) versus 114 after procedural IA (1.8 per 1000) (relative risk RR, 1.87 95% CI, 1.44 to 2.43; absolute risk difference ARD, 1.5 per 1000 CI, 0.9 to 2.2). The respective rates of any adverse event were 28.9 versus 12.4 per 1000 (RR, 2.33 CI, 2.11 to 2.57; ARD, 16.5 per 1000 CI, 14.5 to 18.4). In comparison 2, SAEs occurred among 133 (3.4 per 1000) and 27 (3.3 per 1000) women, respectively (RR, 1.04 CI, 0.61 to 1.78). The respective rates of any adverse event were 31.2 versus 24.9 per 1000 (RR, 1.25 CI, 1.04 to 1.51).
A woman prescribed mifepristone-misoprostol may not have taken the medication, and the exact gestational age at IA was not always known.
Although rare, short-term adverse events are more likely after mifepristone-misoprostol IA than procedural IA, especially for less serious adverse outcomes.
Canadian Institutes of Health Research.
The ABO and rhesus (Rh) blood groups may influence risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
To determine whether ABO and Rh blood groups are associated with ...risk for SARS-CoV-2 infection and severe coronavirus disease 2019 (COVID-19) illness.
Population-based cohort study.
Ontario, Canada.
All adults and children who had ABO blood group assessed between January 2007 and December 2019 and who subsequently had SARS-CoV-2 testing between 15 January and 30 June 2020.
The main study outcome was SARS-CoV-2 infection, determined by viral RNA polymerase chain reaction testing. A second outcome was severe COVID-19 illness or death. Adjusted relative risks (aRRs) and absolute risk differences (ARDs) were adjusted for demographic characteristics and comorbidities.
A total of 225 556 persons were included, with a mean age of 54 years. The aRR of SARS-CoV-2 infection for O blood group versus A, AB, and B blood groups together was 0.88 (95% CI, 0.84 to 0.92; ARD, -3.9 per 1000 CI, -5.4 to -2.5). Rhesus-negative (Rh-) blood type was protective against SARS-CoV-2 infection (aRR, 0.79 CI, 0.73 to 0.85; ARD, -6.8 per 1000 CI, -8.9 to -4.7), especially for those who were O-negative (O-) (aRR, 0.74 CI, 0.66 to 0.83; ARD, -8.2 per 1000 CI, -10.8 to -5.3). There was also a lower risk for severe COVID-19 illness or death associated with type O blood group versus all others (aRR, 0.87 CI, 0.78 to 0.97; ARD, -0.8 per 1000 CI, -1.4 to -0.2) and with Rh- versus Rh-positive (aRR, 0.82 CI, 0.68 to 0.96; ARD, -1.1 per 1000 CI, -2.0 to -0.2).
Persons who rapidly died of severe COVID-19 illness may not have had SARS-CoV-2 testing.
The O and Rh- blood groups may be associated with a slightly lower risk for SARS-CoV-2 infection and severe COVID-19 illness.
Ontario Academic Health Sciences Centre AFP Innovation Fund and the Ontario Ministry of Health and Long-Term Care.
This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/policies/article-withdrawal).This article has been retracted at the request of the ...Editors-in-Chief, and with the full cooperation of the authors of the article.The article used notable portions of text from papers previously published by Pratik Sinha, Carolyn S. Calfee and Kevin L. Delucchi in Crit Care Med 49(2021) e63-e79 (https://doi.org/10.1097/CCM.0000000000004710) and by Bridget E. Weller, Natasha K. Bowen and Sarah J. Faubert in J Black Psychol 46(2020) 287-311 (https://doi.org/10.1177/0095798420930932). While these two papers were cited in the original article, a reader brought to the Editors’ attention areas of verbatim text overlap without clear attribution through the use of quotation marks.One of the conditions of submission of a paper for publication is that authors declare explicitly that their work is original and has not appeared in a publication elsewhere. Re-use of any text must be appropriately cited and made visible/transparent to the reader. The scientific community takes a very strong view on this matter. We apologize to readers of the journal that this was not detected ahead of publication.The article has been republished with an updated version with clear attribution of all text where appropriate.
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