New Delhi: The latest study conducted by Lancet has said that inclusion of pregnant women in Covid19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and avoid the dealy of developing treatment recommendations for pregnant women.
"Exclusions of pregnant women was not well justified as many of the treatments being evaluated have minor low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective Covid19 treatment for this population," said the Lancet study.
Evidence on the effects of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing Covid19, during pregnancy is scare," the study said.
According to a report, a study was conducted on 8,207 pregnant women with Covid19 by done by the US centres for disease control and prevention. The study shows that women infected with COVID have higher risks of being admitted to intensive care unit admission and mechanical ventilation. Factors like age, presence of underlying conditions, race and ethnicity were considered.
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The study noted that registered Covid19 treatment studies including Remdesivir, Hydroxy-chloroquine, corticosteroids, lopinavir-ritonavir among others excluded pregnant women.
Significantly, most studies that specifically mentioned pregnant women in the title were observational studies (cross-sectional, prospective cohort studies, and registries), designers to evaluate pregnant women with Covid19 by focussing on maternal outcomes as a primary endpoint.
Studies that included at least one of the six medications with known safety, or vitamins for which safety data show no or low risk of adverse birth outcomes, routinely excluded pregnant women.
"Reasons for this exclusions are not delineated on clinical trial registration sites but might be due to the perceived risks of use in pregnant women, exposure of the fetus or neonate to medication, and the historical exclusion of pregnant women from clinical trials," the study said.
The Lancet study said that considering the scale of this global pandemic and future epidemics, a public health obligation exists to include pregnant women in treatment and vaccine trials to adequately identify and implement appropriate prevention and care.
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