Pregnant women have been excluded from three-quarters of Covid-19 treatment trials, which risks puts potential effectiveness of treatment at risk, as well as the safety of pregnant women who may be at increased risk of severe illness, a new study published by the Lancet Global Health journal says.
Pregnant women are among those most in need of safe and effective therapies against Covid-19, but they are routinely excluded from the majority of clinical treatment trials, according to the study based on a review of international trial registry data.
The study found that three-quarters of Covid-19 trials reviewed specifically excluded expectant mothers, even though they were investigating medications and vitamins that already have a relatively favourable safety profile during pregnancy, or that are already used in pregnant women
The study’s authors say that given the scale of the pandemic and those that will inevitably follow, there is a public health obligation to include pregnant women in treatment trials to identify and provide appropriate management and care.
“Without explicit and proactive efforts to recruit and retain pregnant women
in therapeutic trials for Covid-19, expectant mothers will suffer from having fewer medical options available to them, because we are not including them in clinical trials”, said author Melanie Taylor from WHO in Switzerland and the US Centers for Disease Control and Prevention.
“There is a very real possibility that treatment could become approved for treatment of Covid-19 without evidence-based guidance for use in pregnant women,” she said.
Co-author Loulou Kobeissi from WHO and HRP in Switzerland adds: “The systematic exclusion of pregnant women
cannot be justified on the basis of safety as many of the medications being evaluated are either not harmful in pregnancy, or their risks are minimal”.
“We are concerned that the resulting evidence gaps and delays will limit our understanding of the effects of treatment, dosing, and side effects in this important population, which can be vastly different from other groups due to the physiological changes that come with pregnancy.”
The review found that that 80% (124) of 155 clinical treatment trials of Covid-19 registered in April 2020, and 75% (538) of 722 trials in July 2020, specifically excluded pregnant women
The authors note that expectant mothers were excluded in three-quarters (130/176) of trials investigating six key drug treatments (lopinavir/ritonavir, chloroquine and hydroxychloroquine, remdesivir, interferon beta, ivermectin, and corticosteroids) previously used as treatments in pregnant women
, as well as most (77%; 27/35) trials evaluating high-dose vitamins (ie, A B-complex, C, D, E, and zinc) for which safety data show no, or minimal risk, of adverse pregnancy or birth outcomes.
The authors also investigated the inclusion eligibility criteria for these trials and found that the principal researchers of these trials did not include an explanation for why pregnant women were excluded. They believe that their exclusion from Covid-19 trials is likely happening due to perceived risks around use in expectant mothers and medication exposure to foetuses or neonates.