To determine if mechanical labour induction can offer a safer and effective alternative to prostaglandins to women with previous caesarean section attempting trial of labour after caesarean (TOLAC).
There is good evidence to show that induction of labour with a transcervical balloon compares favourably with the use of prostaglandins.The cervical balloon works by softening \& stretching the cervix mechanically \& stimulates the release of endogenous prostaglandins. When compared with prostaglandins, meta-analysis have shown that for TCB induction, there is no significant different in caesarean section rates (27% vs 25%) with a reduced risk of hyperstimulation with fetal heart rate change (0.4% vs 3%). Further, when compared against induction with misoprostol, induction with a Foley catheter balloon was found to have a lower rate of caesarean section for a non-reassuring fetal heart rate (RR 0.54, 95% CI 0.37-0.79) and a fewer vaginal instrumental deliveries (RR 0.74, 95% CI 0.55-0.95) \[41\]. One randomized controlled trial of 824 women with no previous caesarean section comparing foley catheter balloon with a prostaglandin E2 gel demonstrated no difference in caesarean section rates \& 2 cases of uterine rupture or perforation in the prostaglandin E2 arm but not in the foley catheter balloon arm. Another study involving 1859 women comparing foley catheter balloon with oral misoprostol showed no difference in caesarean section rates or complications. It was, however, noted that induction with foley catheter balloon more likely required oxytocin induction at 80.3% vs 68.4% for misoprostol. While there were earlier concerns of an increase in infectious morbidity when using mechanical induction of labour due to the presence of a foreign body, more recent RCTs \& meta-analysis have shown that there is no significant increase. One of the main concerns for induction of labour in patients with a previous uterine scar is an increased risk of uterine rupture. One observational study of 20,095 women quoted a risk of uterine rupture in spontaneous labour to be 0.52% \& in prostaglandin-induced labour to be 0.77%. Another observational study involving 33,699 women quoted a risk of 0.4% and 1% respectively. While there are also studies which suggest that there is no significant increase in the rate of uterine rupture, many professional bodies have discouraged prostaglandin-induction in women with previous scars. Due to lower levels of hyperstimulation that could lead to fetal distress or uterine rupture, trans cervical balloon induction has found itself as a possible, safer means of induction of labour for women who are keen for vaginal birth after caesarean and are agreeable with induction. Most RCTs were small in size \& did not demonstrate any uterine rupture or dehiscence. However, 2 retrospective cohort studies involving a size of 2479 \& 208 women respectively showed a uterine rupture rate of about 0.5%. trans cervical balloon induction appears to be a safe method for inducing consenting women keen for vaginal birth after caesarean and this study will contribute towards this body of evidence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
To assess if a cervical balloon catheter (foleys catheter) for mechanical induction of labour is comparable to prostaglandin usage for induction of labour in women who have had a previous caesarean section.
Prostin will be used in the control arm.
National University Hospital, Singapore
Singapore, Singapore
Improvement in Bishops score
Assess for increase in Bishops score from baseline of \<5 (Unfavourable) to \>6
Time frame: 24hours
Achieving active labour
Achieving delivery
Time frame: Within 24-48hours of intervention
Number of PGE tablets required
For the prostin arm - How many tablets required, ie 1 or 2 to achieve improvement in Bishops score
Time frame: Within 24-48hours of intervention
Number of times the foley catheter (cervical balloon) needs to be readjusted
Numerical number of the times the foley catheter needs to be removed, replaced or readjusted
Time frame: Within 24-48hours of intervention
Mode of delivery
Successful vaginal birth after previous caesarean section, or emergency caesarean section
Time frame: Within 24-48hours of intervention
Maternal complications
failed device insertion, inability to void urine following insertion, intolerance of device and early removal, vaginal bleeding after insertion of device, spontaneous membrane rupture.
Time frame: Within 24-48hours of intervention
Fetal complications
fetal distress, meconium-stained liquor, malpresentation, neonatal Apgar score of \<7 at 5 minutes, cord blood pH of ≤7.0, admission to NICU, neonatal hypoxic-ischaemic encephalopathy, neonatal death.
Time frame: Within 24-48hours of intervention
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Infectious complications
intrauterine infection, maternal sepsis (e.g. endometritis, UTI), neonatal sepsis, maternal pyrexia, onset of antibiotics
Time frame: Within 24-48hours of intervention
Labour complications
uterine hyperstimulation (i.e. \>5 contractions / 10mins with abnormal CTG), placental abruption, cord prolapse, postpartum haemorrhage, 3rd / 4th degree perineal tears, uterine rupture.
Time frame: Within 24-48hours of intervention