Pregnancy Related Clinical Trial
Official title:
MEchanical DIlatation of the Cervix in a Scarred Uterus (MEDICS)
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.
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