Application of COOK ok Cervical Ripening Balloon Combined With Artificial Rupture of Membranes and Oxytocin in Labor Induction for Full-term Pregnancy

Abstract Background The use of COOK balloon in the process of induction of labor is gradually promoted. This study was conducted to investigate the safety and efficacy of COOK double balloon dilation for pre-induction cervical maturation and induction of labor. Methods A total of 343 pregnant women with full-term pregnancy in Shanghai Putuo Maternity & Infant Health Hospital from January 1st to September 30th of 2016 were enrolled. Of all the pregnant women, 166 had labor induction, which included the use of a COOK balloon, the implementation of artificial rupture of membranes (AROM) and oxytocin intravenous (IV) drip (COOK group). The other 177 pregnant women with spontaneous rupture of membranes (SROM) and mature cervix only administrated with oxytocin IV drip to promote regular uterus contraction (oxytocin group). Maternal adverse reactions, mode of delivery and delivery outcomes of two groups were subsequently compared between the two groups. Results There were significant differences of maternal age (28.29 ± 3.34 vs. 29.25 ± 3.62 years, P = 0.02), gestational age (283.49 ± 4.53 vs. 274.71 ± 7.04 years, P < 0.001) and birth weight (3435.27 ± 340.29 vs. 3354.63 ± 387.96 g, P = 0.02) between the COOK group and the oxytocin group. There were no significant differences in terms of gravidity, parity, mode of delivery, analgesia, 1 min and 5 min Apgar score, labor time, postpartum hemorrhage, and adverse events. Conclusion Use of a COOK balloon may help full-term pregnancy women with immature cervix obtain the same pregnancy results as those with mature cervix, without extra occurrence of adverse events.Trial registration This is an observational study and no registration is required.