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Clinical study of double-balloon catheter in full-term pregnancy to promote cevical maturity

REN Hong1, FAN Jian-hong1, ZHANG Lin2, YANG Zu-jing2   

  1. 1. Department of Gynaecology and Obstetrics, Baoshan Branch of Huashan Hospital, Fudan University, Shanghai 200431, China; 2. Department of Gynaecology and Obstetrics, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
  • Online:2017-01-28 Published:2017-01-19
  • Supported by:

    Special Fund for Scientific and Technological Innovation of Baoshan District in Shanghai,13-E-27

Abstract:

Objective · To evaluate the efficacy and safety of double-balloon catheters in cervical ripening and labor induction among full-term pregnant women. Methods · This prospective randomized study was conducted between May 2014 and January 2015. A total of 152 full-term primiparas in need of labor induction were recruited. These women were pregnant with single fetuses with vertex presentation and intact membranes, whose Bishop scores were below 6. They were randomly assigned to catheter group (51 cases), control group A (51 cases) and control group B (50 cases), who received cervical ripening with double-balloon catheters, dinoprostone suppositories, and continuous intravenous infusion of oxytocin, respectively. The efficiency of cervical ripening and labor induction, labor modes, perinatal outcomes, delivery courses of 3 groups were recorded and compared. Results · Forty-eight cases (94.1%) in catheter group succeeded in cervical ripening, while 47 cases (92.2%) in control group A and 16 cases (32.7%) in control group B. Double-balloon catheters exhibited to be more effective than intravenous infusion of oxytocin in control group B (P=0.000), but there was no significant difference between catheter group and control group A. Thirty-seven women (72.6%) in catheter group, compared with 39 women (76.5%) in control group A and 19 women (38.0%) in control group B achieved vaginal delivery. Higher vaginal delivery rate were found in catheter group than in control group B (P=0.006). No significant difference was found between catheter group and control group A (P=0.747). Besides, there was no significant difference in total labor duration, as well as in the incidences of amniotic fluid contamination, postpartum hemorrhage and neonatal asphyxia among the three groups (P>0.05). Less adverse reactions were found in catheter group than those in control group A (P=0.003) instead of in control group B (P=0.873). Conclusion · Double-balloon catheters present similar effects with dinoprostone suppositories in preinduction cervical ripening and labor induction, obviously more effective than single use of oxytocin. Furthermore, double-balloon catheters cause less side effects than dinoprostone suppositories.

Key words: double-balloon catheter, dinoprostone suppository, oxytocin, full-term pregnancy, cervical ripening, labor induction