scholarly journals Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21

Author(s):  
Lauren Head Zauche ◽  
Bailey Wallace ◽  
Ashley N. Smoots ◽  
Christine K. Olson ◽  
Titilope Oduyebo ◽  
...  

Abstract Background There is continuing public concern about the safety of COVID-19 vaccination during pregnancy. While there is no compelling biological reason to expect that mRNA COVID-19 vaccination (either preconception or during pregnancy) presents a risk to pregnancy, data are limited. It is, however, well documented that SARS-CoV-2 infection during pregnancy is associated with severe illness and increased risk of adverse pregnancy outcomes. Among recognized pregnancies in high-income countries, 11–16% end in spontaneous abortion (SAB). Methods People enrolled in v-safe, a voluntary smartphone-based surveillance system, who received a COVID-19 vaccine preconception or during pregnancy were contacted by telephone to enroll in the v-safe pregnancy registry. V-safe pregnancy registry participants who received at least one dose of an mRNA COVID-19 vaccine preconception or prior to 20 weeks’ gestation and who did not report a pregnancy loss before 6 completed weeks’ gestation were included in this analysis to assess the cumulative risk of SAB using Life Table methods. Results Among 2,456 pregnant persons who received an mRNA COVID-19 vaccine preconception or prior to 20 weeks’ gestation, the cumulative risk of SAB from 6–19 weeks’ gestation was 14.1% (95% CI: 12.1, 16.1%). Using direct age standardization to the selected reference population, the age-standardized cumulative risk of SAB was 12.8% (95% CI: 10.8–14.8%). Conclusions When compared to the expected range of SABs in recognized pregnancies, these data suggest receipt of an mRNA COVID-19 vaccine preconception or during pregnancy is not associated with an increased risk of SAB. These findings add to accumulating evidence that mRNA COVID-19 vaccines during pregnancy are safe.

Biomedicines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 671
Author(s):  
Cecilia Nalli ◽  
Daniele Lini ◽  
Laura Andreoli ◽  
Francesca Crisafulli ◽  
Micaela Fredi ◽  
...  

Antiphospholipid antibodies (aPL) can induce fetal loss in experimental animal models. Human studies did find hypocomplementemia associated with pregnancy complications in patients with antiphospholipid syndrome (APS), but these results are not unanimously confirmed. To investigate if the detection of low C3/C4 could be considered a risk factor for adverse pregnancy outcomes (APO) in APS and aPL carriers’ pregnancies we performed a multicenter study including 503 pregnancies from 11 Italian and 1 Russian centers. Data in women with APS and asymptomatic carriers with persistently positive aPL and preconception complement levels were available for 260 pregnancies. In pregnancies with low preconception C3/C4, a significantly higher prevalence of pregnancy losses was observed (p = 0.008). A subgroup analysis focusing on triple aPL-positive patients found that preconception low C3 and/or C4 levels were associated with an increased rate of pregnancy loss (p = 0.05). Our findings confirm that decreased complement levels before pregnancy are associated with increased risk of APO. This has been seen only in women with triple aPL positivity, indeed single or double positivity does not show this trend. Complement levels are cheap and easy to be measured therefore they could represent a useful aid to identify patients at increased risk of pregnancy loss.


2008 ◽  
Vol 54 (2) ◽  
pp. 326-334 ◽  
Author(s):  
Linda Dodds ◽  
Deshayne B Fell ◽  
Kent C Dooley ◽  
B Anthony Armson ◽  
Alexander C Allen ◽  
...  

Abstract Background: Increased total homocysteine (tHcy) may be associated with placental-mediated adverse pregnancy outcomes, but few prospective studies have measured tHcy before pregnancy outcome. This study was undertaken to determine whether increased tHcy measured in early pregnancy is associated with pregnancy loss, gestational hypertension (GH), preeclampsia, or small for gestational age (SGA) infants. Methods: We conducted a prospective cohort study between 2002 and 2005. We measured tHcy and serum folate in blood samples from pregnant women (<20 weeks’ gestation) and collected detailed pregnancy information through a questionnaire and medical record review. Results: Of the 2119 women included in the study, 103 had a pregnancy loss, 115 had gestational hypertension, 65 had preeclampsia, and 129 had an SGA infant. Subjects with increased tHcy concentrations were at increased risk of pregnancy loss [relative risk (RR) 2.1, 95% CI 1.2–3.6] or preeclampsia (RR 2.7, 95% CI 1.4–5.0) than subjects with lower tHcy concentrations, but increased tHcy concentration was not associated with increased risk of developing GH or having an SGA infant. Conclusion: The finding of high tHcy in early pregnancy as a risk factor for pregnancy loss and preeclampsia is consistent with a hypothesis that increased tHcy results in abnormalities of the placental vasculature.


Author(s):  
Shamil D. Cooray ◽  
Jacqueline A. Boyle ◽  
Georgia Soldatos ◽  
Shakila Thangaratinam ◽  
Helena J. Teede

AbstractGestational diabetes mellitus (GDM) is common and is associated with an increased risk of adverse pregnancy outcomes. However, the prevailing one-size-fits-all approach that treats all women with GDM as having equivalent risk needs revision, given the clinical heterogeneity of GDM, the limitations of a population-based approach to risk, and the need to move beyond a glucocentric focus to address other intersecting risk factors. To address these challenges, we propose using a clinical prediction model for adverse pregnancy outcomes to guide risk-stratified approaches to treatment tailored to the individual needs of women with GDM. This will allow preventative and therapeutic interventions to be delivered to those who will maximally benefit, sparing expense, and harm for those at a lower risk.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Magnus Bein ◽  
Oriana Hoi Yun Yu ◽  
Sonia Marzia Grandi ◽  
Francesca Y. E. Frati ◽  
Ihab Kandil ◽  
...  

Abstract Background Levothyroxine replacement therapy may decrease the risk of adverse pregnancy outcomes among women with subclinical hypothyroidism (SCH). The aim of this study is to conduct a systematic review and meta-analysis to examine the risk of adverse pregnancy, perinatal, and early childhood outcomes among women with SCH treated with levothyroxine. Methods A systematic literature search was conducted using Ovid-Medline, Ovid-EMBASE, Pubmed (non-Medline), Ebsco-CINAHL Plus with full text and Cochrane Library databases. Randomized controlled studies (RCTs) and observational studies examining the association between treatment of SCH during pregnancy and our outcomes of interest were included. Studies that compared levothyroxine treatment versus no treatment were eligible for inclusion. Data from included studies were extracted and quality assessment was performed by two independent reviewers. Results Seven RCTs and six observational studies met our inclusion criteria. A total of 7342 individuals were included in these studies. RCTs demonstrated several sources of bias, with lack of blinding of the participants or research personnel; only one study was fully blinded. In the observational studies, there was moderate to serious risk of bias due to lack of adjustment for certain confounding variables, participant selection, and selective reporting of results. Pooled analyses showed decreased risk of pregnancy loss (RR: 0.79; 95% CI: 0.67 to 0.93) and neonatal death (RR: 0.35; 95% CI: 0.17 to 0.72) associated with levothyroxine treatment during pregnancy among women with SCH. There were no associations between levothyroxine treatment and outcomes during labour and delivery, or cognitive status in children at 3 or 5 years of age. Conclusion Treatment of SCH with levothyroxine during pregnancy is associated with decreased risks of pregnancy loss and neonatal death. Given the paucity of available data and heterogeneity of included studies, additional studies are needed to address the benefits of levothyroxine use among pregnant women with SCH.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 619.2-620
Author(s):  
D. Lini ◽  
C. Nalli ◽  
L. Andreoli ◽  
F. Crisafulli ◽  
M. Fredi ◽  
...  

Background:The role of complement in the antiphospholipid (aPL) related pathology has been widely studied in animal models. Antiphospholipid antibodies can induce fetal loss in experimental animals but mice deficient in specific complement components (C4, C3, C5) appear somehow protected. In addition, in pregnant mice injected with aPL, antibody deposition has been found at decidual level causing focal necrosis, apoptosis and neutrophil infiltrates and supporting aPL pathogenetic potential. On the other hand, human studies did find hypocomplementemia associated to pregnancy complications in patients with obstetric antiphospholipid syndrome (APS). These results, however, are not unanimously confirmed and, in addition, some studies only show increased levels of complement activation products (i.e. Bb) and not decreased levels of C3 and/or C4. A recently study focusing on complement level in early pregnancy and before pregnancy showed a significant correlation with pregnancy complications and loss in a large cohort of primary APS.Objectives:To investigate if the simple detection of low C3 and/or C4 could be considered a risk factor for adverse pregnancy outcome in APS and aPL carriers pregnancies.Methods:We performed a multicentric study including patients from 10 Italian and 1 Russian Centers. Data on pregnancies in women with primary APS (n=434) and asymptomatic carriers with persistently positive aPL but not fulfilling clinical criteria for APS (n=218) were retrospectively collected. Serum C3 and C4 levels were evaluated by nephelometry; hypocomplementemia was defined by local laboratory reference values. Statistical analysis was performed using GraphPad.Results:Preconceptional complement levels and gestational outcome were available for 107 (25%) pregnancies in APS out of 434 and for 196 (90%) pregnancies in aPL carriers women out of 218. In pregnancies with low preconceptional C3 and/or C4, a significantly higher prevalence of pregnancy losses was observed (p=0.019). A subgroup analysis focusing on triple aPL positive patients was also performed. Preconceptional low C3 and/or C4 levels were found to be associated with an increased rate of pregnancy loss (p = 0.027) in this subgroup also. Otherwise, adverse pregnancy outcomes in single or double aPL positive women were not related to preconception complement levels (p = 0.44) (Table 1). Of note, all the pregnancy losses in the triple positive group occurred in patients treated with low dose aspirin and low molecular weight heparin from the time of positive pregnancy test.Conclusion:Our findings confirm that decreased complement levels before pregnancy are associated with increased risk of adverse outcome. This has been seen only in in women with triple aPL positivity, indeed single or double positivity does not show this trend. Complement levels are cheap and easy to be measured therefore they could represent a useful aid to identify patients at increased risk of pregnancy loss. test positivity.References:[1]De Carolis S, et al. Complementemia and obstetric outcome in pregnancy with antiphospholipid syndrome. Lupus (2012) 21:776–8.[2]Kim MY, et al. Complement activation predicts adverse pregnancy outcome in patients with systemic lupus erythematosus and/or antiphospholipid antibodies. Ann Rheum Dis (2018) 77:549–55.[3]Fredi M, et al. Risk Factors for Adverse Maternal and Fetal Outcomes in Women With Confirmed aPL Positivity: Results From a Multicenter Study of 283 Pregnancies. Front Immunol. 2018 May 7;9:864.Triple aPL positivitySingle or double aPL positivityGestational outcomeLow C3/C4 (n=49)Normal C3/C4(n=17)pLow C3/C4 (n=57)Normal C3/C4(n=165)pTerm live birth (>37w)15 (31%)6 (35%)ns34 (60%)110 (67%)nsPreterm live birth (≤37w)22 (45%)11 (65%)ns15 (26%)38 (23%)nsPregnancy losses (abortion and miscarriages)12 (24%)0 (0%)0.0278 (14%) 17 (10%)nsDisclosure of Interests:None declared


2012 ◽  
Vol 42 (12) ◽  
pp. 2651-2660 ◽  
Author(s):  
J. M. Eagles ◽  
A. J. Lee ◽  
E. Amalraj Raja ◽  
H. R. Millar ◽  
S. Bhattacharya

BackgroundWhen women have a history of anorexia nervosa (AN), the advice given about becoming pregnant, and about the management of pregnancies, has usually been cautious. This study compared the pregnancy outcomes of women with and without a history of AN.MethodWomen with a confirmed diagnosis of AN who had presented to psychiatric services in North East Scotland from 1965 to 2007 were identified. Those women with a pregnancy recorded in the Aberdeen Maternal and Neonatal Databank (AMND) were each matched by age, parity and year of delivery of their first baby with five women with no history of AN. Maternal and foetal outcomes were compared between these two groups of women. Comparisons were also made between the mothers with a history of AN and all other women in the AMND.ResultsA total of 134 women with a history of AN delivered 230 babies and the 670 matched women delivered 1144 babies. Mothers with AN delivered lighter babies but this difference did not persist after adjusting for maternal body mass index (BMI) in early pregnancy. Standardized birthweight (SBW) scores suggested that the AN mothers were more likely to produce babies with intrauterine growth restriction (IUGR) [relative risk (RR) 1.54, 95% confidence interval (CI) 1.11–2.13]. AN mothers were more likely to experience antepartum haemorrhage (RR 1.70, 95% CI 1.09–2.65).ConclusionsMothers with a history of AN are at increased risk of adverse pregnancy outcomes. The magnitude of these risks is relatively small and should be appraised holistically by psychiatric and obstetric services.


2022 ◽  
pp. jech-2021-217754
Author(s):  
Lixin Li ◽  
Yanpeng Wu ◽  
Yao Yang ◽  
Ying Wu ◽  
Yan Zhuang ◽  
...  

BackgroundThe relationship between maternal education and adverse pregnancy outcomes is well documented. However, limited research has investigated maternal educational disparities in adverse pregnancy outcomes in China. This study examined maternal educational inequalities associated with adverse pregnancy outcomes in rural China.MethodsWe conducted a population-based cohort study using participants enrolled in the National Free Preconception Health Examination Project in Yunnan province from 2010 to 2018. The primary outcome was stillbirth, and the secondary outcome was adverse pregnancy outcomes, defined as a composite event of stillbirth, preterm birth or low birth weight. The study was restricted to singleton births at 20–42 weeks’ gestation. Univariate and multivariate log-binomial regression models were performed to estimate crude risk ratios (RRs) and confounding-adjusted RRs (ARRs) for stillbirth and adverse pregnancy outcomes according to maternal education level.ResultsA total of 197 722 singleton births were included in the study. Compared with mid-educated women, low-educated women were at a significantly increased risk of stillbirth (ARR, 1.20; 95% CI, 1.05 to 1.38) and adverse pregnancy outcomes (ARR, 1.11; 95% CI, 1.07 to 1.16). However, the risk of stillbirth (ARR, 1.16; 95% CI, 1.01 to 1.35) was significantly higher for high-educated women compared with mid-educated women.ConclusionCompared with women with medium education level, women with lower education level were more likely to experience adverse pregnancy outcomes, including stillbirth, and women with higher education level were more likely to experience stillbirth.


2018 ◽  
Vol 36 (05) ◽  
pp. 517-521 ◽  
Author(s):  
Whitney Bender ◽  
Adi Hirshberg ◽  
Lisa Levine

Objective To examine the change in body mass index (BMI) categories between pregnancies and its effect on adverse pregnancy outcomes. Study Design We performed a retrospective cohort study of women with two consecutive deliveries from 2005 to 2010. Analysis was limited to women with BMI recorded at <24 weeks for both pregnancies. Standard BMI categories were used. Adverse pregnancy outcomes included preterm birth at <37 weeks, intrauterine growth restriction (IUGR), pregnancy-related hypertension, and gestational diabetes mellitus (GDM). Women with increased BMI category between pregnancies were compared with those who remained in the same BMI category. Results In total, 537 women were included, of whom 125 (23%) increased BMI category. There was no association between increase in BMI category and risk of preterm birth, IUGR, or pregnancy-related hypertension. Women who increased BMI category had an increased odds of GDM compared with women who remained in the same BMI category (6.4 vs. 2.2%; p = 0.018). The increased risk remained after controlling for age, history of GDM, and starting BMI (adjusted odds ratio: 8.2; 95% confidence interval: 2.1–32.7; p = 0.003). Conclusion Almost one-quarter of women increased BMI categories between pregnancies. This modifiable risk factor has a significant impact on the risk of GDM.


2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hayfaa Wahabi ◽  
Samia Esmaeil ◽  
Amel Fayed

The objectives of this study were to estimate the prevalence of prepregnancy overweight/obesity and underweight among Saudi mothers and to determine the adverse pregnancy outcomes associated with them. Methods. This is a subgroup analysis from a Riyadh mother and baby cohort study. Participants were divided into four groups according to prepregnancy BMI. Participants with normal BMI were the reference group. Groups were compared in relation to pregnancy-related obstetric, as well as fetal and neonatal complications. A regression model was used to control for covariates, and adjusted odds ratios (AOR) with 95% Confidence Intervals (95% CI) were calculated. Results. A total of 7,029 women were included, 29.7% had normal BMI, 33.3% were overweight, 34.8% were obese, and 2.2% were underweight. Obesity was associated with increased odds of gestational diabetes (AOR 2.07, 95% CI 1.73-2.47), hypertensive events in pregnancy (AOR 2.33, 95% CI 1.19-3.91), induction of labour (IOL) (AOR 1.40, 95% CI, 1.19-1.65), failed IOL (AOR 2.13, 95% CI 1.40-3.25), and delivery by emergency caesarean section (CS) (AOR 1.67, 95% CI 1.39-2.01). Infants of obese women had increased odds of macrosomia (AOR 3.73, 95% CI 2.33-5.98). Overweight women had increased odds of CS delivery (AOR 1.25, 95% CI 1.03-1.5) and failed IOL (AOR 1.69, 95% CI 1.09-2.60). Underweight women had increased odds of delivering a low birth weight (LBW) infant (AOR 2.49, 95% CI, 1.58-3.92). Conclusion. The prevalence of prepregnancy overweight and obesity is very high in Saudi Arabia. Prepregnancy obesity is associated with GDM and hypertensive events inpregnancy, IOL, failed IOL, and CS delivery. Infants of obese mothers were at higher risk of macrosomia, while underweight women were at increased risk of delivering LBW infants.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
N Balachandren ◽  
M Davies ◽  
J Hall ◽  
D Mavrelos ◽  
E Yasmin

Abstract Study question Are pregnant women in the community with confirmed diagnosis of SARS-CoV–2 infection, at increased risk of an early miscarriage? Summary answer Women diagnosed with COVID–19 in their first trimester were not at increased risk of an early miscarriage. What is known already: In the earliest stages of the pandemic, the Human Fertilisation and Embryology Authority and the European Society of Human Reproduction and Embryology, independently advised against starting assisted reproductive treatments. At the time of this recommendation, among other reasons, there were concerns about the complications of SARS-CoV–2 during pregnancy and the potential for vertical transmission. We now having growing evidence that pregnant women are at an increased risk of severe illness along with higher rates of preterm births in those with severe acute respiratory syndrome. However, data on the impact of community infections of SARS-CoV–2 in early pregnancy has been sparse. Study design, size, duration This is an online survey study undertaken in the UK between May and November 2020. Pregnant women at any stage in their pregnancy were invited to participate in the study. Study participants were asked to complete online surveys at the end of each trimester. 10, 430 women were recruited to take part in the study. Participants/materials, setting, methods: We analysed pregnancy outcomes from women who were under 13 weeks gestation at the time of registration. We compared miscarriage rates among women with a confirmed diagnosis of SARS-CoV–2 infection to healthy controls. Those in the control group had not been diagnosed with or had symptoms of SARS-CoV–2 infection nor did they have any household contacts that were diagnosed with or had symptoms of SARS-CoV–2 infection. Main results and the role of chance 10, 430 pregnant women were recruited to participate in the study. 2934 were under 13 weeks gestation at the time of registration. The median age was 32.6 [IQR 29.8–35.6]. The median gestational age at registration was 8 weeks [IQR [6–10]. 246 women reported a miscarriage before 13 weeks of gestation. The overall miscarriage rate before 13 weeks of gestation was 8.4% (95% CI 7.3%–9.4%). 68 women reported a confirmed diagnosis of SARS-CoV–2 infection in their first trimester. The overall rate of confirmed SARS-CoV–2 infections in the first trimester was 2.3% (95% CI 1.8–2.9%). 3/68 (4.4%) were asymptomatic. Among those reporting symptoms, the commonest symptoms were fatigue (82%), headache (69%) and loss of smell/taste (69%). Only 38% of those with a confirmed diagnosis reported a fever. None of the 68 women with confirmed diagnosis of SARS-CoV–2 infection were hospitalised. The rate of miscarriage before 13 weeks of gestation in women who were diagnosed with SARS-CoV–2 infections was not significantly higher compared to healthy controls (11.8% versus 9.3%, p = 0.35). A further 35 women had household contacts with confirmed SARS-CoV–2 infection although they themselves had not been diagnosed. No miscarriages were reported in this group. Limitations, reasons for caution None of the 68 patients diagnosed with SARS-CoV–2 were hospitalised. We do not know whether the rate of miscarriage among hospitalised women with SARS-CoV–2 infection is the same as those with community infections. Wider implications of the findings: The overall rate of miscarriage during the pandemic was not higher than rates occurring outside of the pandemic. The rate of miscarriage among women diagnosed with SARS-CoV–2 infection was not significantly higher compared to healthy controls. This data can be used to counsel women planning a pregnancy during this pandemic Trial registration number Not applicable


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