Effectiveness, Safety and Place Skills of COOK Cervical Dilatation Balloon for Cervical Ripening and Induced Labor

Abstract

Objective To evaluate the effectiveness, safety and place skills of COOK balloon for cervical ripening and labor induction. Methods A total of 390 pregnant women inducted by COOK balloon combined with oxytocin and inducted only by oxytocin in the Department of Obstetrics, Chengdu Women and Children's Central Hospital, from January 2011 to December 2013 were recorded and analyzed. According to whether to use COOK cervical dilatation balloon for cervical ripening or not, they were divided into experimental group(n=195, use) and control group(n=195, not use). The pregnancy complications, cervical Bishop score, perinatal outcomes, induction process, induction outcomes and the incidence of adverse events were analyzed and compared. The general clinical data of two groups were compared with no statistically significant difference (P>0.05). The study protocol was approved by the Ethical Review Board of Investigation in Human Beings of Chengdu Women and Children's Central Hospital.Informed consent was obtained from each participating patient. Results After balloon removed, the cervical Bishop score of experimental group increased significantly (q=4.564, P=0.000); and was significantly higher than that of control group(q=5.282, P=0.000). The successful induction rate in experimental group was significantly higher than that in control group but the induced failure rate and cesarean section rate by request in experimental group were significantly lower than those in control group (χ2=10.029, 9.176, 7.131; P 0.05). There were no significant differences between two groups about perinatal outcomes(P>0.05). The fetal membrane broken autonomously, balloon fell out, fever, spontaneous labor start, and placental abruption occurred in experimental group. Conclusions COOK cervical dilatation balloon can effectively promote cervical mature with no obvious adverse outcomes.The leucorrhea must be conducted routine examination before placing the balloon, the best time of balloon placed was in the night before going to sleep. After balloon removed, membranes should be artificial ruptured before induction of labor. The fetal membrane should not be ruptured by force if it is difficult to rupture. Key words: Labor stage, first; Cervical ripening; Labor, induced