Medications in Pregnancy & Lactation (MiPaL)
Emeline Maisonneuve, MD (she/her/hers)
PhD student
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
Bern, Bern, Switzerland
Odette de Bruin
PhD student
UMCU, Netherlands
Guillaume Favre, MD
PhD student
Materno-fetal and Obstetrics Research Unit, Woman-Mother-Child Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
Lausanne, Vaud, Switzerland
Anna Goncé, MD PhD
Professora Associada
BCNatal - Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Universitat de Barcelona, Spain
Serena Donati, MD PhD
Researcher/Director
Women, Child and Adolescent Health Unit (National Centre for Disease Prevention and Health Promotion)
Rome, Italy
Hilde Engjom, MD PhD
Researcher
Division for Mental and Physical Health, Norwegian Institute of Public Health
Bergen, Norway
Eimir Hurley, PhD
Post-Doc researcher
Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo
Oslo, Oslo, Norway
Nouf Al-Fadel, PhD
SFDA
Saudi Food and Drug Authority, Ar Riyad, Saudi Arabia
Satu Siiskonen, PhD
Project manager
University of Utrecht
Utrecht, Netherlands
Kitty Bloemenkamp, MD
Professor
Department of Obstetrics, Wilhelmina Children’s Hospital, Division Woman and Baby, University Medical Center Utrecht, Utrecht, the Netherlands
Utrecht, Utrecht, Netherlands
Hedvig Nordeng, PhD
Professor
Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway
Oslo, Oslo, Norway
Miriam C. Sturkenboom, PhD
Professor
Department of Biostatistics and Research support, Julius Center for Health sciences and Primary care, University Medical Center Utrecht, the Netherlands
Utrecht, Utrecht, Netherlands
David Baud, MD PhD
Head of department
Materno-fetal and Obstetrics Research Unit, Woman-Mother-Child department, CHUV Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
Lausanne, Switzerland
Alice Panchaud, PhD
Head of BIHAM Pharmacy
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
Bern, Bern, Switzerland
Background: The lack of inclusion of pregnant people in clinical trials evaluating the effectiveness of medicines to treat COVID-19 has made it more difficult to establish specific guidelines for pregnant people.
Objectives: We aimed to provide a historical review of the evolution of the national guidelines on medicines used in pregnant people with COVID-19.
Methods: We searched for the national guidelines and their updates published by the obstetrician and gynecologists’ societies in the countries participating in the CONSIGN group: Canada, France, Italy, Norway, Saudi Arabia, Spain, Switzerland, The Netherlands, United Kingdom (UK) and United States [US]), and World Health Organization guidelines from March 2020 to December 2021. To harmonize all the terms used in the national recommendations, we used the same terminology as the one published in the WHO guidelines.
Results: During the two first years of the pandemic, the national online guidelines were updated up to 14 times for pregnant people, and 42 times for the NIH recommendations, including a specific section for pregnant people.
Antibiotics were used as a first-line treatment against COVID-19 from the very beginning, due to past successful performance in other viral epidemics as well as to treat pulmonary co-infections. Since mid-2020, most national guidelines did not recommend to prescribe antibiotics such as amoxycillin, unless an additional bacterial pulmonary infection is suspected. After February 2021, the National guidelines have successively recommended not to prescribe azithromycin, unless an additional bacterial pulmonary infection is suspected.
Hydroxychloroquine was initially prescribed in pregnant people in some countries. After the RECOVERY trial in June 2020, the national societies recommended against prescribing it.
Remdesivir has been considered for compassionate use in the US since 2020 and in Belgium and the UK since 2021.
After initial reluctance to use steroids, the results of the RECOVERY trial 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 evidence of systemic inflammation since June 2021.
In May 2021, the US-FDA expanded the emergency use authorization to include pregnancy as a qualifying condition for anti-SARS-CoV-2 monoclonal antibodies.
In December 2021, the FDA restricted the authorization of convalescent plasma to the treatment of COVID-19 in immunocompromised patients.
Since July 2020, the NIH recommends against the use of polyvalent IVIg to treat COVID-19 in adults, except in a clinical trial setting.
In December 2021, the US guidelines supported the use of nirmatrelvir-ritonavir in pregnant people with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19. In response, the Society for Maternal Fetal Medicine supports its use for treatment of pregnant patients with COVID-19 who meet clinical qualifications.
Since the early pandemic, prophylactic coagulation is recommended conditionally on hospitalization and/or personal thromboembolic risk factors in pregnancy in most national guidelines, unless delivery is imminent within 12 hours.
Conclusion: The gradual convergence of the recommendations highlights the importance of inclusion of pregnant people in clinical trials and of international collaboration to improve the pharmacological management of pregnant people with COVID-19.