An interventional study of Cervical balloon and Prostaglandins in Pregnancy Related, Labor Complication and Cesarean Section; Dehiscence, sponsored by Ministry of Health, Singapore. Completed at 1 site in Singapore. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Ministry of Health, Singapore · Not applicable, Interventional, and Treatment
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.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's enrollment of 44 is below the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →This is the only study on the registry with Ministry of Health, Singapore as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcervical 2-way 18 French (18F) single balloon Foley catheter, applied using a sponge-holding forceps into the cervical canal with the balloon inflated to a minimum of 30ml and maximum of 60ml with sterile water or saline \[1\]. This will be administered once during the study and will be retained for a maximum of 12 hours within the 24 hour study period.
Device: Cervical balloon
Prostaglandin E2 (Prostin®) 3mg tablet, placed high in the vaginal fornix. This will be administered per vaginum once in the first 6 hours; a second dose is administered at the discretion of the clinician / clinical team 6 hours after the first pessary, for a cumulative total of 6mg within the 24 hour study period.
Drug: Prostaglandins
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.
Also known as: Foley Balloon Catheter
Prostin will be used in the control arm.
Also known as: Prostin
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
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
Plan to share: No
Ran from Aug 2019 to primary completion in Aug 2022, 35 months.
Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's 35 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Prostaglandins
Obstetric Labor Complications →