Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE₂ gel

TLDR

Induction of labour in nulliparous women with unfavourable cervices is associated with high caesarean delivery rates. The study aimed to compare the efficacy and patient satisfaction of double balloon catheters, single balloon catheters, and prostaglandin gel for labour induction in term nulliparous women with unfavourable cervices. A randomised controlled trial of 330 term nulliparous women compared double balloon catheters, single balloon catheters, and PGE₂ gel for cervical ripening. The trial found no difference in caesarean rates, but the double balloon catheter had a longer induction‑to‑delivery interval, PGE₂ gel caused uterine hyperstimulation and slightly worse cord blood gases, and the single balloon catheter offered comparable efficacy with less pain and better safety.

Abstract

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.Randomised controlled trial.A total of 330 nulliparous women with unfavourable cervices induced at term.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).Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction.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).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.