title: Continuous controllable balloon dilation: a novel approach for cervix dilation.
abstract: BACKGROUND
  Cervical dilation using mechanical dilators is associated with various complications, such as uterine perforation, cervical laceration, infections and intraperitoneal hemorrhage. To achieve safe and painless cervical dilation, we constructed a new medical device to achieve confident mechanical cervical dilation: a continuous controllable balloon dilator (CCBD).
  
  
  METHODS
  Controlled pumping of incompressible fluid into the CCBD increases the pressure and outer diameter of the CCBD, continuously dilating the cervical canal. The reliability of the CCBD was confirmed in vitro (testing for consistency and endurance, with no detected risk for breakage) and in vivo. A multi-center clinical study was conducted,with 120 pregnant women randomly assigned to one of three groups: Group I,control group, no dilation;Group II,mechanical dilation, Hegar dilator (HeD); and Group III,CCBD. The tissue material for histological evaluation was obtained from the endocervical mucosa before and after dilation using the HeD or CCBD.
  
  
  RESULTS
  The CCBD dilations were successful and had no complications in all 40 patients of Group III. The cervical tissue was markedly less damaged after CCBD dilation compared with HeD dilation (epithelium damage: 95% (HeD) vs. 45% (CCBD), P <0.001; basal membrane damage: 82.5% (HeD) vs. 27.5% (CCBD), P <0.001; stromal damage: 62.5% (HeD) vs. 37.5% (CCBD), P <0.01). Cervical hemorrhagia was observed in 90% of the patients after HeD dilation versus in 32.5% of the patients after CCBD dilation.
  
  
  CONCLUSIONS
  The CCBD should be used as a replacement for mechanical dilators to prevent uterine and cervical injury during cervical dilation.
  
  
  BACKGROUND
  ISRCTN54007498.
authors.affiliation: Center for Molecular Medicine & Stem Cell Research Faculty of Medicine, University of Kragujevac, 69 Svetozara Markovica Street, Kragujevac, 34 000, Serbia. drvolarevic@yahoo.com.
authors.forename: Slobodan
authors.initials: S
authors.lastname: Arsenijevic
authors.forename: Gordana
authors.initials: G
authors.lastname: Vukcevic-Globarevic
authors.forename: Vladislav
authors.initials: V
authors.lastname: Volarevic
authors.forename: Ivan
authors.initials: I
authors.lastname: Macuzic
authors.forename: Petar
authors.initials: P
authors.lastname: Todorovic
authors.forename: Irena
authors.initials: I
authors.lastname: Tanaskovic
authors.forename: Milan
authors.initials: M
authors.lastname: Mijailovic
authors.forename: Sasa
authors.initials: S
authors.lastname: Raicevic
authors.forename: Branislav
authors.initials: B
authors.lastname: Jeremic
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000293:injuries / Q000473:pathology; D004106:Dilatation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D005260:Female; D006801:Humans; D054548:Montenegro; D010865:Pilot Projects; D011247:Pregnancy; D011312:Pressure; D055771:Serbia; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000209:etiology / Q000473:pathology; D014947:Wounds and Injuries / Q000209:etiology / Q000473:pathology; D055815:Young Adult