Objective To evaluate the efficacy and safety of labor induction by the double balloon device in women with preeclampsia and eclampsia.Methods Labor induction was carried out in 37 women with preeclampsia and eclampsia from July 2011 to November 2012.All the labor inductions were performed using the double balloon device.Results The cervical Bishop scores of 37 cases of patients with preeclampsia and eclampsia were significantly lower before using double balloon device [(3.38 ± 0.50) scores] compared with after using double balloon device [(6.44 ± 0.63) scores] with a statistically significant difference (t =23.54,P ＜0.01).Blood pressure had no obvious change before and after using double balloon device [SBP(158.38 ± 13.89)mmHg vs (162.48 ± 12.56)mmHg,P ＞ 0.05,and SDP(112.71± 15.53) mmHg vs (108.19 ± 8.37) mmHg,P ＞ 0.05].The rate of vaginal delivery was 89.2％ (33/37),and the total hours of labor were (5.8 ± 0.63) h.Compared with selective cesarean section,vaginal delivery after double balloon to promote cervical mature had less blood loss (t =9.19,P ＜0.01),quicker postpartum recovery,shorter hospitalization time (t =11.18,P ＜ 0.01),lower birth body mass (t =2.96,P ＜0.01) and higher scores of 1 minutes Apgar score (t =2.34,P ＜0.05).Conclusions The double balloon device appeared to be a safe and effective method to induce labor in women with preeclampsia and eclampsia.Wide scale studies and further use of the device for labor induction in women with preeclampsia and eclampsia were warranted.

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
Device Approval ; China ; Equipment and Supplies