Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action

Abstract

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of nonbiological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavirritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated highdose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.

Wellbeing of Breastfeeding Women in Australia and New Zealand during the COVID-19 Pandemic: A Cross-Sectional Study

“…Despite the recommendation to continue breastfeeding, during the COVID-19 pandemic, the mental health and wellbeing of pregnant and breastfeeding women remain a concern [9][10][11]. New mothers' access to support has diminished, and breastfeeding support has not adapted to the new pandemic environment [12].…”

Neonatal SARS-CoV-2 Infection: Practical Tips

“…From the pharmacological point of view, most clinical trials did not include pregnant women with ongoing infection, although the safety of various drugs (i.e., lopinavir-ritonavir and remdesivir) during pregnancy has already been evaluated previously [ 32 ]. In neonatal age, no therapy is usually required in asymptomatic cases, while supportive therapy and paracetamol are recommended in mild–moderate cases.…”

“…The clinical conditions of the mother and neonate seem the best indicator for hospital discharge of the mother–infant dyad. From the studies carried out to date, it seems that the concentration of SARS-CoV-2 RNA measured in the samples from the upper respiratory tract is reduced after the onset of symptoms in patients with mild-to-moderate forms [ 32 ]. The replicating virus was not found 10 days after the onset of the disease, although the absence of viral replication between 10 and 20 days after the onset of symptoms has been documented in immunocompromised individuals with serious clinical forms [ 54 ].…”

Pre-Exposure Prophylaxis for COVID-19 in Pregnant Women

“…44 Nevertheless, HCQ PrEP RCTs could be attempted in this population in conjunction with appropriate patient education about safety and efficacy of this FDAapproved medication. 45 In the face of a public health crisis, it is important to consider life-saving approaches based on scientific logic, safety considerations, and clinical availability even if definitive evidence is lacking. 1…”