Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.
The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.
“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.
Dr. Marrs reported no conflicts of interest.
SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.