Foley bulb insertion by blind placement compared with direct visualization: A randomized controlled trial
Obstetrics and Gynecology Dec 23, 2020
Kuhlmann MJ, Spencer N, Garcia-Jasso C, et al. - Via performing an open-label noninferiority randomized trial, researchers sought to test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection. They randomized 372 pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced) to a balloon catheter that was placed either digitally or using a sterile speculum. Outcomes support noninferiority of digital placement of a balloon catheter for preinduction cervical ripening to the sterile speculum method, in terms of maternal infection. A second round of the mechanical dilator was more frequently required in women in the sterile speculum group. They support the reasonability of the blind digital approach for balloon placement for cervical ripening.
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