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.Design Randomised controlled trial.Population 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).Main outcome measures 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 ‡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.Keywords Induction of labour, mechanical ripening, nulliparous women, prostaglandin, randomised controlled trial, unfavourable cervix.Please cite this paper as: Pennell C, Henderson J, O'Neill M, McCleery S, Doherty D, Dickinson J. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE 2 gel.

A comparative study of intra-cervical foley's catheter and PGE2 gel for pre-induction cervical ripening

“…The rate of LSCS in our study is agreeable. 16,19 There was no association of increased rate of cesarean section with the Foley's catheter PGE2 gel use.…”

A prospective randomized comparative study of intra-cervical Foley\s catheter insertion versus PGE2 gel for pre-induction cervical ripening

“…6,9 There was no association of increased rate of cesarean section with the Foley's catheter PGE 2 gel use. 8,9 Fetal outcome data showed no significant difference between Group A and Group B with respect to birth wt (2.67 ± 0.44 and 2.58, / = 4.28, 3df, p = 0.188), MAS (8 and 10 respectively), 1 min Apgar score <7 (14 and 17 respectively), NICU admission rate (38 and 43 respectively). Thus the present study shows that the fetal outcome results were also comparable in both the groups.…”

Induction of Labor by Prostaglandin: A Review for Indications and Risk for Cesarean Section

“…However, most of the studies found higher rate of successful delivery after induction. The reason for which cesarean section was Mishanina et al [48] 2014 Systematic review and meta-analysis Decreased Hofmeyr and Gulmezoglu [92] 2001 Systematic review Decreased Wood et al [93] 2014 Meta-analysis Decreased Gulmezoglu et al [47] 2006 Systematic review Decreased Gulmezoglu et al [94] 2012 Systematic review Decreased Sanchez Ramos et al [29] 2003 Systematic review Decreased Alfirevic et al [76] 2014 Systematic review Decreased Alfirevic et al [95] 2000 Systematic review Decreased Boulvain et al [30] 2008 Systematic review Decreased Vogel et al [35] 2013 Systematic review Decreased Crowley [96] 2000 Systematic review No difference Boulvain et al [73] 2016 Systematic review Not clear Guerra et al [26] 2009 Secondary analysis Decreased Cheng [97] 2008 RCT Decreased Koopmans et al [98] 2009 RCT Decreased Pennel et al [99] 2009 RCT Increased Bhutto et al [100] 2013 RCT Nil Hermus et al [101] 2009 Cohort No difference Marry et al [37] 2015 Cohort Decreased Yeast et al [102] 1999 Cohort Decreased Nooh et al [103] 2005 Retrospective Decreased Dubline et al [19] 2000 Cohort Increased Johnson et al [104] 2003 Cohort Increased Verhoeven et al [22] 2012 Case control Increased…”