title: Trans-cervical double balloon catheter with and without extra-amniotic saline infusion for cervical ripening: a prospective quasi-randomized trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of the trans-cervical double balloon catheter with and without extra-amniotic saline infusion (EASI) for cervical ripening.
  
  
  METHODS
  This is a secondary analysis of a prospective randomized study conducted between November 2007 and January 2011 evaluating different ripening methods. Women presenting for labor induction were assigned to receive the double balloon catheter with (study group) or without EASI (control group). Outcomes included time from device insertion to delivery, cesarean section rates, and adverse events.
  
  
  RESULTS
  One hundred and sixty women completed the study. Cesarean section rate (8.3% in study group, versus 20% in controls p = 0.07) and ripening success were comparable between the groups. Catheter insertion to delivery interval was significantly shorter and spontaneous catheter expulsion rate was significantly higher in the study group (14:19 hours versus 20:45 hours, p < 0.001, and 68.5% versus 51%, p = 0.04, respectively). Hospitalization length was significantly shorter in the study arm. There were no differences in other outcomes evaluated. A multivariable analysis found the EASI to be an independent predictor of a shorter insertion to delivery interval.
  
  
  CONCLUSIONS
  The addition of EASI to the double balloon catheter for cervical ripening results in a shorter labor induction process without compromising its safety.
authors.affiliation: Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center , Hadera , Israel and.
authors.forename: Asnat
authors.initials: A
authors.lastname: Walfisch
authors.forename: Elad
authors.initials: E
authors.lastname: Mei-Dan
authors.forename: Mordechai
authors.initials: M
authors.lastname: Hallak
mesh_terms: D000328:Adult; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D020070:Cervical Ripening; D002585:Cesarean Section / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods*; D007902:Length of Stay / Q000706:statistics & numerical data; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D011446:Prospective Studies; D012965:Sodium Chloride / Q000008:administration & dosage*; D013997:Time Factors
chemical_list: D012965:Sodium Chloride
keywords: Atad catheter; cesarean section rate; induction to delivery interval; labor induction; mechanical ripening