Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel
Article first published online: 28 JUL 2009
© 2009 The Authors Journal compilation © RCOG 2009 BJOG An International Journal of Obstetrics and Gynaecology
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 116, Issue 11, pages 1443–1452, October 2009
How to Cite
Pennell, C., Henderson, J., O’Neill, M., McCleery, S., Doherty, D. and Dickinson, J. (2009), Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG: An International Journal of Obstetrics & Gynaecology, 116: 1443–1452. doi: 10.1111/j.1471-0528.2009.02279.x
- Issue published online: 16 SEP 2009
- Article first published online: 28 JUL 2009
- Accepted 20 May 2009. Published Online 28 July 2009.
Vol. 118, Issue 4, 521, Article first published online: 10 FEB 2011
- Induction of labour;
- mechanical ripening;
- nulliparous women;
- randomised controlled trial;
- unfavourable cervix
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 PGE2 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%, PGE2 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 PGE2 (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE2 group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE2 group: median arterial pH double balloon 7.26 (range 7.03–7.40); single balloon 7.26 (7.05–7.44); PGE2 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%, PGE2 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.