Extended Data Table 4 Number and percentage of women with adverse maternal/fetal outcomes of interest by group and trimester of randomization

From: Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial

  1. This table presents a summary of adverse maternal/fetal outcomes of interest by group and by trimester of randomization. There appear to be some differences in terms of trimester at randomization. For example, the percentage of participants with any adverse outcome of interest in group A (8/51 (15.7%) in their first trimester, 36/723 (5.0%) in their second trimester and 7/203 (3.4%) in their third trimester) appears slightly different from group B (2/51 (3.9%) in their first trimester, 56/767 (7.3%) in their second trimester and 15/182 (8.2%) in their third trimester). As another example, the data suggest an inverse relationship between stillbirth and group by trimester (the highest percentages were observed in women in their third trimester in group A and women in their first trimester in group B) as well as an inverse (although now in the opposite direction) relationship between premature labor and group by trimester (the highest percentages were observed in women in their first trimester in group A and women in their third trimester in group B). The confidence intervals are wide around estimates from the relatively small number of women who were randomized during their first trimester. Differences are attributed to random variations due to the small number of women in their first trimester, and no biological explanation for these patterns can be drawn.
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