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  1. Article: Are maternal vaccines effective and safe for mothers and infants? A systematic review and meta-analysis of randomised controlled trials.

    de Bruin, Odette / Phijffer, Emily / Ahmadizar, Fariba / van der Maas, Nicoline / Wildenbeest, Joanne / Sturkenboom, Miriam / Bont, Louis / Bloemenkamp, Kitty

    BMJ global health

    2023  Volume 8, Issue 10

    Abstract: Introduction: Maternal vaccination is a promising strategy to reduce the burden of vaccine-preventable diseases for mothers and infants. We aimed to provide an up-to-date overview of the efficacy and safety of all available maternal vaccines.: Methods! ...

    Abstract Introduction: Maternal vaccination is a promising strategy to reduce the burden of vaccine-preventable diseases for mothers and infants. We aimed to provide an up-to-date overview of the efficacy and safety of all available maternal vaccines.
    Methods: We searched PubMed, Embase, CENTRAL and ClinicalTrials.gov on 1 February 2022, for phase III and IV randomised controlled trials (RCTs) that compared maternal vaccination against any pathogen with placebo or no vaccination. Primary outcomes were laboratory-confirmed or clinically confirmed disease in mothers and infants. Secondary safety outcomes included intrauterine growth restriction, stillbirth, maternal death, preterm birth, congenital malformations and infant death. Random effects meta-analysis were used to calculate pooled risk ratio's (RR). Quality appraisal was performed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE).
    Results: Six RCTs on four maternal vaccines, influenza, tetanus, diphtheria and pertussis (Tdap), pneumococcal and respiratory syncytial virus (RSV) were eligible. The overall risk of bias and certainty of evidence varied from low to high. Maternal influenza vaccination significantly reduced the number of laboratory-confirmed influenza cases (RR 0.58, 95% CI 0.42 to 0.79, event rate 57 vs 98, 2 RCTs, n=6003, I
    Conclusions: The few RCTs with low event rates suggest that, depending on the type of maternal vaccine, the vaccine might effectively prevent disease and within its size does not show safety concerns in mothers and infants.
    Prospero registration number: CRD42021235115.
    MeSH term(s) Infant, Newborn ; Female ; Humans ; Infant ; Influenza, Human/prevention & control ; Influenza Vaccines/therapeutic use ; Mothers ; Vaccination ; Respiratory Tract Infections ; Randomized Controlled Trials as Topic
    Chemical Substances Influenza Vaccines
    Language English
    Publishing date 2023-10-28
    Publishing country England
    Document type Meta-Analysis ; Systematic Review ; Journal Article
    ISSN 2059-7908
    ISSN 2059-7908
    DOI 10.1136/bmjgh-2023-012376
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Respiratory syncytial virus vaccination during pregnancy for improving infant outcomes.

    Phijffer, Emily Wem / de Bruin, Odette / Ahmadizar, Fariba / Bont, Louis J / Van der Maas, Nicoline At / Sturkenboom, Miriam Cjm / Wildenbeest, Joanne G / Bloemenkamp, Kitty Wm

    The Cochrane database of systematic reviews

    2024  Volume 5, Page(s) CD015134

    Abstract: Background: Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections (LRTIs) in infants. Maternal RSV vaccination is a preventive strategy of great interest, as it could have a substantial impact on infant RSV disease ... ...

    Abstract Background: Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections (LRTIs) in infants. Maternal RSV vaccination is a preventive strategy of great interest, as it could have a substantial impact on infant RSV disease burden. In recent years, the clinical development of maternal RSV vaccines has advanced rapidly.
    Objectives: To assess the efficacy and safety of maternal respiratory syncytial virus (RSV) vaccination for preventing RSV disease in infants.
    Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register and two other trials registries on 21 October 2022. We updated the search on 27 July 2023, when we searched MEDLINE, Embase, CENTRAL, CINAHL, and two trials registries. Additionally, we searched the reference lists of retrieved studies and conference proceedings. There were no language restrictions on our searches.
    Selection criteria: We included randomised controlled trials (RCTs) comparing maternal RSV vaccination with placebo or no intervention in pregnant women of any age. The primary outcomes were hospitalisation with clinically confirmed or laboratory-confirmed RSV disease in infants. The secondary outcomes covered adverse pregnancy outcomes (intrauterine growth restriction, stillbirth, and maternal death) and adverse infant outcomes (preterm birth, congenital abnormalities, and infant death).
    Data collection and analysis: We used standard Cochrane methods and assessed the certainty of evidence using the GRADE approach.
    Main results: We included six RCTs (25 study reports) involving 17,991 pregnant women. The intervention was an RSV pre-F protein vaccine in four studies, and an RSV F protein nanoparticle vaccine in two studies. In all studies, the comparator was a placebo (saline, formulation buffer, or sterile water). We judged four studies at overall low risk of bias and two studies at overall high risk (mainly due to selection bias). All studies were funded by pharmaceutical companies. Maternal RSV vaccination compared with placebo reduces infant hospitalisation with laboratory-confirmed RSV disease (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.31 to 0.82; 4 RCTs, 12,216 infants; high-certainty evidence). Based on an absolute risk with placebo of 22 hospitalisations per 1000 infants, our results represent 11 fewer hospitalisations per 1000 infants from vaccinated pregnant women (15 fewer to 4 fewer). No studies reported infant hospitalisation with clinically confirmed RSV disease. Maternal RSV vaccination compared with placebo has little or no effect on the risk of congenital abnormalities (RR 0.96, 95% CI 0.88 to 1.04; 140 per 1000 with placebo, 5 fewer per 1000 with RSV vaccination (17 fewer to 6 more); 4 RCTs, 12,304 infants; high-certainty evidence). Maternal RSV vaccination likely has little or no effect on the risk of intrauterine growth restriction (RR 1.32, 95% CI 0.75 to 2.33; 3 per 1000 with placebo, 1 more per 1000 with RSV vaccination (1 fewer to 4 more); 4 RCTs, 12,545 pregnant women; moderate-certainty evidence). Maternal RSV vaccination may have little or no effect on the risk of stillbirth (RR 0.81, 95% CI 0.38 to 1.72; 3 per 1000 with placebo, no difference with RSV vaccination (2 fewer to 3 more); 5 RCTs, 12,652 pregnant women). There may be a safety signal warranting further investigation related to preterm birth. This outcome may be more likely with maternal RSV vaccination, although the 95% CI includes no effect, and the evidence is very uncertain (RR 1.16, 95% CI 0.99 to 1.36; 6 RCTs, 17,560 infants; very low-certainty evidence). Based on an absolute risk of 51 preterm births per 1000 infants from pregnant women who received placebo, there may be 8 more per 1000 infants from pregnant women with RSV vaccination (1 fewer to 18 more). There was one maternal death in the RSV vaccination group and none in the placebo group. Our meta-analysis suggests that RSV vaccination compared with placebo may have little or no effect on the risk of maternal death (RR 3.00, 95% CI 0.12 to 73.50; 3 RCTs, 7977 pregnant women; low-certainty evidence). The effect of maternal RSV vaccination on the risk of infant death is very uncertain (RR 0.81, 95% CI 0.36 to 1.81; 6 RCTs, 17,589 infants; very low-certainty evidence).
    Authors' conclusions: The findings of this review suggest that maternal RSV vaccination reduces laboratory-confirmed RSV hospitalisations in infants. There are no safety concerns about intrauterine growth restriction and congenital abnormalities. We must be careful in drawing conclusions about other safety outcomes owing to the low and very low certainty of the evidence. The evidence available to date suggests RSV vaccination may have little or no effect on stillbirth, maternal death, and infant death (although the evidence for infant death is very uncertain). However, there may be a safety signal warranting further investigation related to preterm birth. This is driven by data from one trial, which is not fully published yet. The evidence base would be much improved by more RCTs with substantial sample sizes and well-designed observational studies with long-term follow-up for assessment of safety outcomes. Future studies should aim to use standard outcome measures, collect data on concomitant vaccines, and stratify data by timing of vaccination, gestational age at birth, race, and geographical setting.
    MeSH term(s) Humans ; Pregnancy ; Female ; Respiratory Syncytial Virus Infections/prevention & control ; Randomized Controlled Trials as Topic ; Respiratory Syncytial Virus Vaccines/administration & dosage ; Respiratory Syncytial Virus Vaccines/therapeutic use ; Respiratory Syncytial Virus Vaccines/adverse effects ; Infant ; Infant, Newborn ; Stillbirth/epidemiology ; Premature Birth/prevention & control ; Premature Birth/epidemiology ; Pregnancy Complications, Infectious/prevention & control ; Hospitalization/statistics & numerical data ; Fetal Growth Retardation/prevention & control ; Pregnancy Outcome ; Vaccination ; Congenital Abnormalities/prevention & control ; Bias ; Infant Death/prevention & control
    Chemical Substances Respiratory Syncytial Virus Vaccines
    Language English
    Publishing date 2024-05-02
    Publishing country England
    Document type Journal Article ; Systematic Review ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD015134.pub2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Evolution of National Guidelines on Medicines Used to Treat COVID-19 in Pregnancy in 2020-2022: A Scoping Review.

    Maisonneuve, Emeline / de Bruin, Odette / Favre, Guillaume / Goncé, Anna / Donati, Serena / Engjom, Hilde / Hurley, Eimir / Al-Fadel, Nouf / Siiskonen, Satu / Bloemenkamp, Kitty / Nordeng, Hedvig / Sturkenboom, Miriam / Baud, David / Panchaud, Alice

    Journal of clinical medicine

    2023  Volume 12, Issue 13

    Abstract: The lack of inclusion of pregnant women in clinical trials evaluating the effectiveness of medicines to treat COVID-19 has made it difficult to establish evidence-based treatment guidelines for pregnant women. Our aim was to provide a review of the ... ...

    Abstract The lack of inclusion of pregnant women in clinical trials evaluating the effectiveness of medicines to treat COVID-19 has made it difficult to establish evidence-based treatment guidelines for pregnant women. Our aim was to provide a review of the evolution and updates of the national guidelines on medicines used in pregnant women with COVID-19 published by the obstetrician and gynecologists' societies in thirteen countries in 2020-2022. Based on the results of the RECOVERY (Randomized Evaluation of COVID-19 Therapy) trial, the national societies successively recommended against prescribing hydroxychloroquine, lopinavir-ritonavir and azithromycin. Guidelines for remdesivir differed completely between countries, from compassionate or conditional use to recommendation against. Nirmatrelvir-ritonavir was authorized in Australia and the UK only in research settings and was no longer recommended in the UK at the end of 2022. After initial reluctance to use corticosteroids, the results of the RECOVERY trial have enabled the recommendation of dexamethasone in case of severe COVID-19 since mid-2020. Some societies recommended prescribing tocilizumab to pregnant patients with hypoxia and systemic inflammation from June 2021. Anti-SARS-CoV-2 monoclonal antibodies were authorized at the end of 2021 with conditional use in some countries, and then no longer recommended in Belgium and the USA at the end of 2022. The gradual convergence of the recommendations, although delayed compared to the general population, highlights the importance of the inclusion of pregnant women in clinical trials and of international collaboration to improve the pharmacological treatment of pregnant women with COVID-19.
    Language English
    Publishing date 2023-07-06
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12134519
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Variations across Europe in hospitalization and management of pregnant women with SARS-CoV-2 during the initial phase of the pandemic: Multi-national population-based cohort study using the International Network of Obstetric Survey Systems (INOSS).

    de Bruin, Odette / Engjom, Hilde / Vousden, Nicola / Ramakrishnan, Rema / Aabakke, Anna J M / Äyräs, Outi / Donati, Serena / Jónasdóttir, Eva / Knight, Marian / Overtoom, Evelien M / Salvatore, Michele A / Sturkenboom, Miriam C J M / Svanvik, Teresia / Varpula, Reetta / Vercoutere, An / Bloemenkamp, Kitty W M

    Acta obstetricia et gynecologica Scandinavica

    2023  Volume 102, Issue 11, Page(s) 1521–1530

    Abstract: Introduction: The majority of data on COVID-19 in pregnancy are not from sound population-based active surveillance systems.: Material and methods: We conducted a multi-national study of population-based national or regional prospective cohorts using ...

    Abstract Introduction: The majority of data on COVID-19 in pregnancy are not from sound population-based active surveillance systems.
    Material and methods: We conducted a multi-national study of population-based national or regional prospective cohorts using standardized definitions within the International Network of Obstetric Survey systems (INOSS). From a source population of women giving birth between March 1 and August 31, 2020, we included pregnant women admitted to hospital with a positive SARS-CoV-2 PCR test ≤7 days prior to or during admission and up to 2 days after birth. The admissions were further categorized as COVID-19-related or non-COVID-19-related. The primary outcome of interest was incidence of COVID-19-related hospital admission. Secondary outcomes included severe maternal disease (ICU admission and mechanical ventilation) and COVID-19-directed medical treatment.
    Results: In a source population of 816 628 maternities, a total of 2338 pregnant women were admitted with SARS-CoV-2; among them 940 (40%) were COVID-19-related admissions. The pooled incidence estimate for COVID-19-related admission was 0.59 (95% confidence interval 0.27-1.02) per 1000 maternities, with notable heterogeneity across countries (I
    Conclusions: During the initial months of the pandemic, we found substantial variations in incidence of COVID-19-related admissions in nine European countries. Few pregnant women received COVID-19-directed medical treatment. Several barriers to rapid surveillance were identified. Investment in robust surveillance should be prioritized to prepare for future pandemics.
    MeSH term(s) Infant ; Pregnancy ; Female ; Humans ; SARS-CoV-2 ; COVID-19/epidemiology ; COVID-19/therapy ; Pandemics ; Pregnant Women ; Prospective Studies ; Anticoagulants ; Cohort Studies ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/therapy ; Venous Thromboembolism/epidemiology ; Hospitalization ; Europe/epidemiology
    Chemical Substances Anticoagulants
    Language English
    Publishing date 2023-08-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80019-3
    ISSN 1600-0412 ; 0001-6349
    ISSN (online) 1600-0412
    ISSN 0001-6349
    DOI 10.1111/aogs.14643
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: COVID-19-related medicine utilization study in pregnancy: The COVI-PREG cohort.

    Favre, Guillaume / Gerbier, Eva / Maisonneuve, Emeline / Pomar, Léo / Winterfeld, Ursula / Lepigeon, Karine / Bloemenkamp, Kitty W M / de Bruin, Odette / Hurley, Eimir / Nordeng, Hedvig / Siiskonen, Satu J / Sturkenboom, Miriam C J M / Baud, David / Panchaud, Alice

    British journal of clinical pharmacology

    2022  Volume 89, Issue 5, Page(s) 1560–1574

    Abstract: Aim: The objective of this study was to describe the use of COVID-19-related medicines during pregnancy and their evolution between the early/late periods of the pandemic.: Methods: Pregnant women who tested positive for SARS-CoV-2 from March 2020 to ...

    Abstract Aim: The objective of this study was to describe the use of COVID-19-related medicines during pregnancy and their evolution between the early/late periods of the pandemic.
    Methods: Pregnant women who tested positive for SARS-CoV-2 from March 2020 to July 2021 were included using the COVI-PREG registry. Exposure to the following COVID-19-related medicines was recorded: antibiotics, antivirals, hydroxychloroquine, corticosteroids, anti-interleukin-6 and immunoglobulins. We described the prevalence of medicines used, by trimester of pregnancy, maternal COVID-19 severity level and early/late period of the pandemic (before and after 1 July 2020).
    Findings: We included 1964 pregnant patients who tested positive for SARS-CoV-2. Overall, 10.4% (205/1964) received at least one COVID-19-related medicine including antibiotics (8.6%; 169/1694), corticosteroids (3.2%; 62/1964), antivirals (2.0%; 39/1964), hydroxychloroquine (1.4%; 27/1964) and anti-interleukin-6 (0.3%; 5/1964). The use of at least one COVID-19-related medicine was 3.1% (12/381) in asymptomatic individuals, 4.2% (52/1233) in outpatients, 19.7% (46/233) in inpatients without oxygen, 72.1% (44/61) in those requiring standard oxygen, 95.7% (22/23) in those requiring high flow oxygen, 96.2% (25/26) in patients who required intubation and 57.1% (4/7) among patients who died. The proportion who received medicines to treat COVID-19 was higher before than after July 2020 (16.7% vs. 7.7%). Antibiotics, antivirals and hydroxychloroquine had lower rates of use during the late period.
    Conclusion: Medicine use in pregnancy increased with disease severity. The trend towards increased use of corticosteroids seems to be aligned with changing guidelines. Evidence is still needed regarding the effectiveness and safety of COVID-19-related medicines in pregnancy.
    MeSH term(s) Humans ; Female ; Pregnancy ; COVID-19/epidemiology ; SARS-CoV-2 ; Hydroxychloroquine/therapeutic use ; Antiviral Agents/therapeutic use ; Inpatients ; Pregnancy Complications, Infectious/drug therapy ; Pregnancy Complications, Infectious/epidemiology
    Chemical Substances Hydroxychloroquine (4QWG6N8QKH) ; Antiviral Agents
    Language English
    Publishing date 2022-12-16
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.15611
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