Misleading Abstract: No Random Allocation in “Epidural Analgesia During Labor: Impact on Delivery Outcome,Neonatal Well-Being,and Early Breastfeeding”

Dear Editor:

We read with interest the study by Gizzo et al. ¹ entitled “Epidural Analgesia During Labor: Impact on Delivery Outcome, Neonatal Well-Being, and Early Breastfeeding.” In the Results section of their abstract, the authors claim that “We randomized [study participants] in 64 women in Group A and 64 women in Group B,” implying that each of the 128 women studied had an equal chance of being in Group A or B before the study intervention as in a randomized controlled trial.

However, in the Subjects and Methods section of the full article, they indicate that mothers were selected for each study group without randomization between groups. The only randomization that took place was in the selection of the 64 mothers in the control group who were randomly selected from a larger pool of women who had not received any labor analgesia.

Although this study is an important contribution to the literature, the authors misrepresented the study methods in its abstract, methods that have an important impact on the internal validity of the results. Without random allocation between two study groups, there is great potential for selection bias whereby variables may exist for which the authors did not account, but that nevertheless may differ between the study groups and therefore confound the results. Furthermore, we note the study lacks a power calculation, something that should always be considered in the setting of a negative study.

This article would be much stronger if the limitations were acknowledged rather than camouflaged. We're disappointed that the abstract does not accurately reflect the methods used and want to make sure your readership is not misled.