Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials.

ABSTRACT:

Background

For 30 years, women have sought equal opportunity to be included in trials so that drugs are equitably studied in women as well as men; regulatory guidelines have changed accordingly. Pregnant women, however, continue to be excluded from trials for non-obstetric conditions, though they have been included for trials of life-threatening diseases because prospects for maternal survival outweighed potential fetal risks. Ebola virus disease is a life-threatening infection without approved treatments or vaccines. Previous Ebola virus (EBOV) outbreak data showed 89-93% maternal and 100% fetal/neonatal mortality. Early in the 2013-2016 EBOV epidemic, an expert panel pointed to these high mortality rates and the need to prioritize and preferentially allocate unregistered interven

SUBMITTER: Gomes MF 

PROVIDER: S-EPMC5751665 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature