title: Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel.
abstract: OBJECTIVE
  To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices.
  
  
  METHODS
  Randomised controlled trial.
  
  
  METHODS
  A total of 330 nulliparous women with unfavourable cervices induced at term.
  
  
  METHODS
  Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE(2) gel (2 mg) (113 women).
  
  
  METHODS
  Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction.
  
  
  RESULTS
  There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE(2) 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE(2) (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE(2) group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE(2) group: median arterial pH double balloon 7.26 (range 7.03-7.40); single balloon 7.26 (7.05-7.44); PGE(2) 7.25 (6.91-7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score > or =4: double balloon 55%, single balloon 36%, PGE(2) 63%, P < 0.001).
  
  
  CONCLUSIONS
  Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort.
authors: School of Women's and Infants' Health, The University of Western Australia, Crawley, WA, Australia. craig.pennell@uwa.edu.au
authors: C E
authors: CE
authors: Pennell
authors: J J
authors: JJ
authors: Henderson
authors: M J
authors: MJ
authors: O'Neill
authors: S
authors: S
authors: McChlery
authors: S
authors: S
authors: McCleery
authors: D A
authors: DA
authors: Doherty
authors: J E
authors: JE
authors: Dickinson
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002404:Catheterization / Q000009:adverse effects / Q000379:methods*; D020070:Cervical Ripening; D002585:Cesarean Section / Q000706:statistics & numerical data; D015232:Dinoprostone; D005260:Female; D005312:Fetal Blood / Q000737:chemistry; D005782:Gels; D006801:Humans; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods*; D007744:Obstetric Labor Complications / Q000628:therapy*; D010120:Oxytocics; D010146:Pain / Q000209:etiology; D010298:Parity; D017060:Patient Satisfaction; D011247:Pregnancy; D013997:Time Factors; D016896:Treatment Outcome; D014904:Western Australia; D055815:Young Adult
chemical_list: D005782:Gels; D010120:Oxytocics; D015232:Dinoprostone