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DOI: 10.1055/a-2576-6293
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Original Article

Vaccine Effectiveness in SARS-CoV-2-Infected Pregnant Women with Gestational Diabetes Mellitus: Results from a Multicenter Registry-Based Prospective Cohort Study in Germany

Impfstoffwirksamkeit bei mit SARS-CoV-2 infizierten schwangeren Frauen mit Gestationsdiabetes: Ergebnisse einer multizentrischen registerbasierten prospektiven Kohortenstudie in Deutschland
Eike A. Strathmann
1   Institute of Epidemiology, Kiel University, Kiel, Germany
,
Katharina S. Weber
1   Institute of Epidemiology, Kiel University, Kiel, Germany
,
Babett Ramsauer
2   Department for Obstetric Medicine, Clinicum Neukoelln, Vivantes Network of Health GmbH, Berlin, Germany
,
Dietmar Schlembach
2   Department for Obstetric Medicine, Clinicum Neukoelln, Vivantes Network of Health GmbH, Berlin, Germany
,
Janine Zöllkau
3   Department of Obstetrics, Competence Center for Diabetic Women, Jena University Hospital, Jena, Germany
,
Ute M. Schaefer-Graf
4   Department of Obstetrics, Berlin Center for Diabetes and Pregnancy, St. Joseph Hospital, Berlin, Germany
,
Sophia Ajouby
5   Department of Obstetrics and Gynecology, Frauenklinik Dr. Geisenhofer, München, Germany
,
Kristin Andresen
6   Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Campus Kiel, Kiel, Germany
,
Michael K. Bohlmann
7   Department of Obstetrics and Gynecology, St. Elisabeth Hospital, Loerrach, Germany
,
Iris Dressler-Steinbach
8   Department of Obstetrics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
,
Antonella Iannaccone
9   Department of Obstetrics and Gynecology, University Hospital of Essen, Essen, Germany
,
Peter Jakubowski
10   Department of Womenʼs Health, University Hospital Tuebingen, Tuebingen, Germany
,
Mirjam Kunze
11   Department of Obstetrics and Gynecology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany
,
Bettina Kuschel
12   Sektion Geburtshilfe und Perinatologie, Klinikum rechts der Isar, Technical University Munich, Munich, Germany
,
Nadine Mand
13   Department of Pediatrics, University Hospital Marburg, Marburg, Germany
,
Mandy Mangler
14   Department of Obstetrics and Gynecology, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany
,
Valerie Meister
15   Department of Obstetrics and Gynecology, Starnberg Clinic, Starnberg, Germany
,
Kathleen M. Oberste
16   Department of Obstetrics and Gynecology, University Hospital of Münster, Münster, Germany
,
Katharina Rathberger
17   Department of Obstetrics and Gynecology, Barmherzige Brüder Hospital, Regensburg, Germany
,
Kristin Reinhardt
18   Department of Obstetrics, Martin Luther University Hospital, Halle, Germany
,
Lydia Remtisch
19   Department of Obstetrics, University Hospital Leipzig, Leipzig, Germany
,
Linda Wegner
20   Department of Obstetrics and Gynecology, St. Franziskus Hospital, Muenster, Germany
,
Katharina Weizsäcker
8   Department of Obstetrics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
,
Feline Wowretzko
21   Department of Obstetrics and Gynecology, Asklepios Hospital Wandsbek, Hamburg, Germany
,
Mario Rüdiger
22   Saxony Center for Feto/Neonatal Health, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Ulrich Pecks
23   Department of Obstetrics, University Hospital Würzburg, Würzburg, Germany
24   Department of Midwifery Science, Julius Maximilians University Würzburg, Würzburg, Germany
,
Helmut J. Kleinwechter
25   diabetologikum kiel, Diabetes Excellence Center Diabetes and Pregnancy (German Diabetes Association), Kiel, Germany
,
on behalf of the COVID-19-Related Obstetric and Neonatal Outcome Study (CRONOS) Network › InstitutsangabenGerman Diabetes Association and German Diabetes Foundation (FP-0443-2022); State government of Schleswig-Holstein (K128002). The German Society of Perinatal Medicine (DGPM) provided logistic support. The funding organizations have neither involvement in the design and conduct of the study, collection, management, analysis, interpretation of data, preparation, review, approval of the manuscript, nor the decision to submit the manuscript for publication.
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Erratum zu diesem Artikel:

Correction: Vaccine Effectiveness in SARS-CoV-2-Infected Pregnant Women with Gestational Diabetes Mellitus: Results from a Multicenter Registry-Based Prospective Cohort Study in GermanyGeburtshilfe Frauenheilkd eFirst
DOI: 10.1055/a-2597-8003

Abstract

Introduction COVID-19 in pregnancy is associated with increased maternal and neonatal morbidity and mortality. The aim of our study was to investigate the effectiveness of COVID-19 vaccination in SARS-CoV-2-infected pregnant women with focus on women with gestational diabetes mellitus on pregnancy outcomes.

Patients and Methods COVID-19 Obstetric and Neonatal Outcome study is a multicenter prospective observational study which registered SARS-CoV-2-infected pregnant women from April 2020 to December 2022. In March 2021, the study was complemented by the SATELLITES study which recruited vaccinated women until September 2023. Primary composite maternal and neonatal endpoints were defined. Multivariate adjusted logistic regression analysis was performed to evaluate the impact of vaccination on pregnancy outcomes. Vaccine effectiveness was defined as (1-adjusted odds ratio)*100.

Results We registered 10 386 pregnant women, 6112 of whom were analyzed. 30% of women were vaccinated against COVID-19. Vaccination in women with gestational diabetes mellitus was associated with a vaccine effectiveness of 75% (95% CI: 16 – 93), depending on the predominant virus variant, and of 67% in the total cohort (95% CI: 36 – 83). No statistically significant difference was found in vaccine effectiveness with regards to perinatal outcomes of women with gestational diabetes mellitus (16%; 95% CI −58 – 55) but there was an impact in the total cohort (26%; 95% CI 8 – 94).

Conclusion For pregnant women with gestational diabetes mellitus who were infected with SARS-CoV-2, at least one vaccination against COVID-19 before or during pregnancy was independently associated with a milder course of COVID-19 in mothers compared to no vaccination. We found no evidence of improved perinatal outcomes. The data emphasize the benefits of vaccination before or during pregnancy.

Zusammenfassung

Einleitung Eine COVID-19-Erkrankung in der Schwangerschaft ist mit höherer mütterlicher und fetaler Morbidität und Mortalität verbunden. Ziel dieser Studie war es, die Wirksamkeit einer COVID-19-Impfung bei mit SARS-CoV-2 infizierten schwangeren Frauen zu untersuchen mit besonderem Augenmerk auf die Schwangerschaft-Outcomes von Frauen mit Gestationsdiabetes.

Patientinnen und Methoden Die COVID-19 Obstetric and Neonatal Outcome Studie ist eine multizentrische prospektive Beobachtungsstudie, die von April 2020 bis Dezember 2022 mit COVID-19 infizierte schwangere Frauen registrierte. Im März 2021 wurde die Studie durch die SATELLITES-Studie ergänzt, die geimpfte Frauen bis September 2023 rekrutierte. Die primären zusammengefassten mütterlichen und neonatalen Endpunkten wurden definiert. Es wurde eine multivariate logistische Regressionsanalyse durchgeführt, um die Auswirkungen von Impfungen auf das Schwangerschafts-Outcome zu evaluieren. Die Imfpstoffwirksamkeit wurde als (1-adjusted Odds Ratio)*100 definiert.

Ergebnisse Insgesamt wurden 10 386 schwangere Frauen registriert, davon wurden 6112 in die Analyse eingeschlossen; 30% der Frauen waren gegen COVID-19 geimpft. Je nach vorherrschender Virusvariante betrug die Impfstoffwirksamkeit hinsichtlich des zusammengefassten mütterlichen Endpunkts 75% (95%-KI 16 – 93) bei Frauen mit Gestationsdiabetes und 67% (95%-KI 36 – 83) für die Gesamtkohorte. Hinsichtlich des perinatalen Outcomes gab es keinen statistisch signifikanten Unterschied zwischen geimpften und ungeimpften Frauen mit Gestationsdiabetes (16%; 95%-KI −58 – 55), wohl aber in der Gesamtkohorte (26%; 95%-KI 8 – 94).

Schlussfolgerung Bei schwangeren Frauen mit Gestationsdiabetes, die mit SARS-CoV-2 infiziert wurden, zeigte sich, dass mindestens eine Impfung gegen COVID-19 vor oder während der Schwangerschaft mit einem milderen Verlauf der COVID-19 Erkrankung assoziiert war, verglichen mit Frauen, die keine Impfung erhalten hatten. Es gab keine Hinweise auf ein besseres perinatales Outcome. Diese Daten unterstreichen die Vorteile einer Impfung vor oder während der Schwangerschaft.

Keywords

diabetes - SARS-CoV-2 - pregnancy - vaccination - impaired glucose tolerance

Schlüsselwörter

Diabetes - SARS-CoV-2 - Schwangerschaft - Impfung - Glukosetoleranzstörung


Publikationsverlauf

Eingereicht: 19. Januar 2025

Angenommen nach Revision: 03. April 2025

Artikel online veröffentlicht:
29. April 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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