Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial.

PURPOSE: To analyze the effect of combined application of intravaginal PGE2 insert and intracervical Foley balloon catheter for induction of labor.

METHODS: Patients with unfavorable cervices who required induction of labor from August 2017 to December 2017 were evaluated for the study. Three hundred and ten participants were randomly assigned to study (n:155) and control group (n:155). Nine patients in study group and seven patients in control group were excluded, because they declined to participate in the study. Totally, 294 women analyzed in this prospective randomized study: Group 1 (control group): labor induction with intravaginal PgE2 vaginal insert alone (n = 148) and Group 2 (study group): intracervical Foley balloon catheter insertion adjunct to the intravaginal PgE2 insert (n = 146). The primary outcome of our study was the period from induction to delivery. The secondary outcome was the period from induction to active phase of labor.

RESULTS: In the analysis of primiparous pregnants, combination of intracervical Foley balloon catheter and intravaginal PgE2 insertion was shown to be associated with shorter duration from induction to active stage of labor (1000 vs. 585 min, P < 0.001) and also to delivery (1386 vs. 1001 min, P < 0.001). Groups were found to be similar in terms of duration from induction to active stage of labor (670.5 vs. 535.2, P > 0.05) and also to delivery (933.1 vs. 777.9, P > 0.05, Table 2) in subgroup of women with the previous vaginal delivery.

CONCLUSIONS: Combined application of intracervical Foley balloon catheter and intravaginal PgE2 insert may result in a shorter time from labor induction to delivery without rising the risk of cesarean section in primiparous women with an unfavorable cervix.