Evaluation of cervical ripening between transcervical foley catheter versus hygroscopic cevical dilator (laminaria tent) for induction of labour in women with previous caesarean delivery: prospective randomized study

Objective: To compare the efficacy and safety between transcervical Foley catheter and hygroscopic mechanical dilator for induction of labour in women agreed for vaginal birth after caesarean section (VBAC) with unfavorable cervix at term. Study Design: This is a prospective randomized controlled trial conducted at a tertiary hospital on 60 women who agreed for trial of vagina delivery after cesarean section and required induction of labour due to various indications. The first group, 30 women underwent induction with 60 ml Foley catheter whereas the second group, 30 women had underwent induction with laminaria tent. The monitoring and induction procedure was standardized between both groups. Outcomes that were measured after 24 hours of induction were the obstetrics outcome of both devices such as Bishop’s score changes and successful induction rate in term of vagina delivery. Others outcomes were maternal and fetal complication related to delivery such as post partum hemorrhage, infection and immediate Apgar score for neonate upon delivery. The economic outcome was also compared for both devices in relation to cost of induction and total cost of hospital stay. Results: Among 60 patients, 30 patients were induced with Foley catheter whereas another 30 patients were induced with laminaria tent. All demographic data were comparable between both groups (P>0.05). There was no statistical significant increase in the Bishop score for all cases with the mean were 1.57(0.87) for the entire cohort (Foley’s: 4.20 to 5.77; Laminaria: 4.10 to 5.26; P>0.05). The rate of successful induction was 55% with vaginal birth accounting for 53.3% whereas the rate of caesarean section was 46.7% of all cases (Foley’s: SVD; 18 (60%) /CS; 12(40%), Laminaria: SVD; 14(46.7%) / CS; 16(53.3%), P>0.05). The incidence of complication such as post partum hemorrhage was recorded in 10 cases (16.7%) (Foley’s: 6 (10%); Laminaria: 4 (6.68%); P>0.05). and Apgar score less than 9 was observed in 3 cases (5%) (Foley’s: 2 (6.7%); Laminaria: 1 (3.3%); P>0.05). Higher mean total economic cost (induction and hospitalization) was observed in laminaria group (Foley’s: RM 105; Laminaria: RM163) although not statistical significant (P>0.05). None of the patients and newborn showed any clinical signs of infection during the study period. Implication for practice: This study concluded that both devices are equally safe and efficacious as induction agent with no increase risk of infection and uterine rupture in women with previous caesarean section. Foley catheter would be an effective and cheaper alternative for induction agent in places where laminaria are not available especially in rural area in Sabah.