title: Women's acceptance of a double-balloon device as an additional method for inducing labour.
abstract: OBJECTIVE
  A wide variety of pharmacological and mechanical methods (e.g. balloon devices) are available for inducing labour, but little information is available about the way in which women regard balloon devices. The aim of this study was to investigate women's acceptance of and satisfaction with the induction of labour by administration of oral misoprostol and the combination of that with a double-balloon device.
  
  
  METHODS
  The study included 122 women with term pregnancies who required induction of labour between August 2009 and November 2010. They all participated in a randomized controlled trial to test different ways of inducing labour and were randomly assigned either to a 'study group' (with a combination of oral misoprostol and a double-balloon catheter) or a 'control group' (with oral misoprostol alone). After childbirth, a standardized questionnaire was given to all of the women for them to complete before discharge. In addition to assessing the induction of labour and their level of satisfaction with regard to delivery, the birth experience was objectively evaluated using the German-language version of Salmon's Item List (SIL-Ger). For statistical analysis, the chi-squared test, Fisher's exact test, the binomial test, the t-test, or the Mann-Whitney U-test for independent samples were used as appropriate. A significance level of 5% was chosen.
  
  
  RESULTS
  Seventy-eight questionnaires were included in the analysis. The women were not bothered either by the placement of the double-balloon device (P=0.017) or by the presence of the catheter (P=0.002). In comparison with the control group, women in the study group would consider their method in a subsequent pregnancy and would recommend it to others more often (P=0.040). The SIL-Ger score showed a positive birth experience in both groups, with a significantly better score in the study group (87.7 ± 15.8 vs 79.3 ± 17.3 in the control group; P=0.030). The multivariate analysis identified three factors influencing the SIL-Ger score: satisfaction with childbirth (P<0.001), involvement in decision-making after childbirth (P=0.041), and the method of labour induction (combination of oral misoprostol and double-balloon catheter vs oral misoprostol alone; P=0.005).
  
  
  CONCLUSIONS
  The women were satisfied with the induction of labour using oral misoprostol and the combination of that with a double-balloon catheter. The double-balloon catheter was accepted by the women, and surprisingly was found to have a positive impact on the birth experience.
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Heidelberg University, Germany. sven.kehl@umm.de
authors.forename: Sven
authors.initials: S
authors.lastname: Kehl
authors.forename: Grit
authors.initials: G
authors.lastname: Welzel
authors.forename: Anna
authors.initials: A
authors.lastname: Ehard
authors.forename: Sebastian
authors.initials: S
authors.lastname: Berlit
authors.forename: Saskia
authors.initials: S
authors.lastname: Spaich
authors.forename: Jörn
authors.initials: J
authors.lastname: Siemer
authors.forename: Marc
authors.initials: M
authors.lastname: Sütterlin
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002404:Catheterization / Q000379:methods*; D020070:Cervical Ripening / Q000187:drug effects; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage*; D010120:Oxytocics / Q000008:administration & dosage; D017060:Patient Satisfaction; D011247:Pregnancy
chemical_list: D010120:Oxytocics; D016595:Misoprostol