Dataset Information

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

ABSTRACT:

Introduction

Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.

Aim

We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.

Methods

We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines.

Results

During the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy-related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69-0.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05-1.38 and ROR 1.26, 95% CI 1.08-1.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64-0.84). In addition, 5.8% of ICSRs reported a fatal outcome.

Conclusions

No strong insight of unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.

SUBMITTER: Mascolo A

PROVIDER: S-EPMC9574088 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

Mascolo Annamaria A di Mauro Gabriella G Fraenza Federica F Gaio Mario M Zinzi Alessia A Pentella Ciro C Rossi Francesco F Capuano Annalisa A Sportiello Liberata L

Frontiers in immunology 20221003

<h4>Introduction</h4>Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.<h4>Aim</h4>We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.<h4>Methods</h4>We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the Eudr ...[more]

PMID: 36263025

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Project description:BackgroundThe rarity of pregnancies in women with arthrogryposis multiplex congenita (AMC) could lead to healthcare providers having limited exposure to these cases. Consequently, they may be less familiar with the possibilities and challenges associated with pregnancies in women affected by AMC. AMC is an umbrella term for a disorder with multiple contractures at birth, having a broad spectrum of causes, onset and severity of expression. A clinical classification describing the phenotype is Group 1 with primary limb involvement, Group 2 with musculoskeletal involvement plus other system anomalies, and Group 3 with musculoskeletal involvement plus central nervous system dysfunction and/or intellectual disability. A scoping review was conducted to review available literature on documented cases of pregnancies in women with AMC, with the following aims: (1) to outline the maternal, fetal and neonatal outcomes; (2) to describe AMC stability during and after pregnancy (worsening of symptoms due to contractures, increased muscle weakness, pain or lung involvement); and (3) to summarize counselling aspects during pregnancy for expecting mothers who have AMC.ResultsThis scoping review included 27 manuscripts reporting on 43 women with 82 pregnancies, of whom 18 in Group 1, 20 in Group 2, 2 in Group 3, and 3 with an unknown type. Details on pregnancy-related outcomes could be depicted from 26 of the 43 women concerning 31 pregnancies. Among these pregnancies, 74% (23/31) had a cesarean section delivery, of which 74% (17/23) were elective. Children were born preterm before week 37 in 7 of 31 pregnancies (22%). A birth weight below the 10th percentile was seen in 6 of the 24 (25%) with a reported birth weight. The course of the pregnancy was uneventful in 16 of the 26 women (62%). Pregnancy had a limited negative influence on AMC stability except for three cases with a transient worsening of lung function.ConclusionsGathering the information of the case histories revealed that the majority of the reported women had Distal Arthrogryposis with stable AMC during pregnancy and after delivery. The risk to have a cesarean section, preterm labour or a small for gestational age child is higher in this group than in the general population. Insights obtained by this review emphasized to offer (pre)pregnancy counselling and care by a multidisciplinary team tailored to the women's type of AMC, to ensure optimal preparation for both obstetric, genetic, neurologic, pulmonary and anesthetic care during pregnancy, delivery and postpartum period.

Project description:Background Pregnant women with underlying heart disease ( HD ) are at increased risk for adverse maternal, obstetric, and neonatal outcomes. Methods and Results Inpatient maternal delivery admissions and linked neonatal stays for women with cardiomyopathy, adult congenital HD, pulmonary hypertension ( PH ), and valvular HD were explored utilizing the Statewide Planning and Research Cooperative System (New York), January 1, 2000, through December 31, 2014, with the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Maternal major adverse cardiac events, neonatal adverse clinical events ( NACE ), and obstetric complications were recorded. Outcomes were compared using multiple logistic regression modeling. Among 2 284 044 delivery admissions, 3871 women had HD ; 676 (17%) had cardiomyopathy, 1528 (40%) had valvular HD, 1367 (35%) had adult congenital HD, and 300 (8%) had PH . Major adverse cardiac events occurred in 16.1% of women with HD , with most in the cardiomyopathy (45.9%) and PH (25%) groups. NACE was more common in offspring of women with HD (18.4% versus 7.1%), with most in the cardiomyopathy (30.0%) and PH (25.0%) groups. Increased risk of NACE was noted for women with HD (odds ratio [ OR ]: 2.8; 95% confidence interval [ CI ], 2.5-3.0), with the highest risk for those with cardiomyopathy ( OR : 5.9; 95% CI , 5.0-7.0) and PH ( OR : 4.5; 95% CI , 3.4-5.9). Preeclampsia ( OR : 5.1; 95% CI , 3.0-8.6), major adverse cardiac events ( OR : 2.3; 95% CI , 1.8-2.9), preexisting diabetes mellitus ( OR : 4.3; 95% CI , 1.5-12.3), and obstetric complications ( OR : 2.9; 95% CI , 1.7-5.2) were independently associated with higher NACE risk. Conclusions Neonatal complications were higher in offspring of pregnant women with HD , particularly cardiomyopathy and PH . Preeclampsia, major adverse cardiac events, obstetric complications, and preexisting diabetes mellitus were independently associated with a higher risk of NACE .

Dataset Information

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

Introduction

Aim

Methods

Results

Conclusions

Publications

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

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