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

Eike A. Strathmann; Katharina S. Weber; Babett Ramsauer; Dietmar Schlembach; Janine Zöllkau; Ute M. Schaefer-Graf; Sophia Ajouby; Kristin Andresen; Michael K. Bohlmann; Iris Dressler-Steinbach; Antonella Iannaccone; Peter Jakubowski; Mirjam Kunze; Bettina Kuschel; Nadine Mand; Mandy Mangler; Valerie Meister; Kathleen M. Oberste; Katharina Rathberger; Kristin Reinhardt; Lydia Remtisch; Linda Wegner; Katharina Weizsäcker; Feline Wowretzko; Mario Rüdiger; Ulrich Pecks; Helmut J. Kleinwechter; on behalf of the COVID-19-Related Obstetric and Neonatal Outcome Study (CRONOS) Network

doi:10.1055/a-2576-6293

Geburtshilfe und Frauenheilkunde, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd
DOI: 10.1055/a-2576-6293

GebFra Science

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

¹Institute of Epidemiology, Kiel University, Kiel, Germany

,

Katharina S. Weber

¹Institute of Epidemiology, Kiel University, Kiel, Germany

,

Babett Ramsauer

²Department for Obstetric Medicine, Clinicum Neukoelln, Vivantes Network of Health GmbH, Berlin, Germany

,

Dietmar Schlembach

²Department for Obstetric Medicine, Clinicum Neukoelln, Vivantes Network of Health GmbH, Berlin, Germany

,

Janine Zöllkau

³Department of Obstetrics, Competence Center for Diabetic Women, Jena University Hospital, Jena, Germany

,

Ute M. Schaefer-Graf

⁴Department of Obstetrics, Berlin Center for Diabetes and Pregnancy, St. Joseph Hospital, Berlin, Germany

,

Sophia Ajouby

⁵Department of Obstetrics and Gynecology, Frauenklinik Dr. Geisenhofer, München, Germany

,

Kristin Andresen

⁶Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Campus Kiel, Kiel, Germany

,

Michael K. Bohlmann

⁷Department of Obstetrics and Gynecology, St. Elisabeth Hospital, Loerrach, Germany

,

Iris Dressler-Steinbach

⁸Department of Obstetrics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany

,

Antonella Iannaccone

⁹Department of Obstetrics and Gynecology, University Hospital of Essen, Essen, Germany

,

Peter Jakubowski

¹⁰Department of Womenʼs Health, University Hospital Tuebingen, Tuebingen, Germany

,

Mirjam Kunze

¹¹Department of Obstetrics and Gynecology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany

,

Bettina Kuschel

¹²Sektion Geburtshilfe und Perinatologie, Klinikum rechts der Isar, Technical University Munich, Munich, Germany

,

Nadine Mand

¹³Department of Pediatrics, University Hospital Marburg, Marburg, Germany

,

Mandy Mangler

¹⁴Department of Obstetrics and Gynecology, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany

,

Valerie Meister

¹⁵Department of Obstetrics and Gynecology, Starnberg Clinic, Starnberg, Germany

,

Kathleen M. Oberste

¹⁶Department of Obstetrics and Gynecology, University Hospital of Münster, Münster, Germany

,

Katharina Rathberger

¹⁷Department of Obstetrics and Gynecology, Barmherzige Brüder Hospital, Regensburg, Germany

,

Kristin Reinhardt

¹⁸Department of Obstetrics, Martin Luther University Hospital, Halle, Germany

,

Lydia Remtisch

¹⁹Department of Obstetrics, University Hospital Leipzig, Leipzig, Germany

,

Linda Wegner

²⁰Department of Obstetrics and Gynecology, St. Franziskus Hospital, Muenster, Germany

,

Katharina Weizsäcker

⁸Department of Obstetrics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany

,

Feline Wowretzko

²¹Department of Obstetrics and Gynecology, Asklepios Hospital Wandsbek, Hamburg, Germany

,

Mario Rüdiger

²²Saxony Center for Feto/Neonatal Health, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

,

Ulrich Pecks

²³Department of Obstetrics, University Hospital Würzburg, Würzburg, Germany

²⁴Department of Midwifery Science, Julius Maximilians University Würzburg, Würzburg, Germany

,

Helmut J. Kleinwechter

²⁵diabetologikum 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

› Institutsangaben

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

Volltext

Referenzen

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