Pregnancy RelatedMEDICSNCT03471858
Mechanical Dilation of the Cervix in a Scarred Uterus
A study testing Cervical balloon and Prostaglandins in people with Pregnancy Related and Labor Complication, run by Ministry of Health, Singapore at 1 site in Singapore.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Labor Complication, Cesarean Section; Dehiscence
- What is being tested?
- Cervical balloon and Prostaglandins
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Aug 2019to 16 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female ≥ 21 years of age at booking visit
- 1 previous uncomplicated lower segment caesarean section (CS)
- Aiming for TOLAC
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
- Singleton pregnancy
- Gestational age >37 weeks
Show all 12Show fewer
- Understands risk of TOLAC
- Eligible for induction of labour for the standard obstetric indications, including post-date or post-term pregnancies at 40-41 completed weeks of gestation
- Unfavourable Bishop's Score ≤ 5 requiring cervical priming
- Previous uterine surgery, including simple myomectomy, where there is no contraindication to TOLAC
- Reactive CTG pre-induction
- Ruptured membranes
Who cannot join
- Refusal to participate
- Women with 2 or more previous CS
- Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery
- Previous uterine surgery with contra-indication to future TOLAC
- Maternal contraindication for vaginal delivery
- Fetal contraindication for vaginal delivery or major fetal abnormality
Show all 14Show fewer
- Malpresentation or cord presentation
- Placenta praevia <20mm from internal os
- Chorioamnionitis
- Antepartum haemorrhage of undetermined origin AND deemed a contraindication for TOLAC
- Suspected fetal macrosomia (estimated weight on ultrasound >4kg) AND deemed a contraindication for TOLAC
- Congenital uterine abnormality
- Multifetal pregnancy
- Latex allergy or poorly-controlled asthma
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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.
- Being tested
- Cervical balloon, Prostaglandins
- Keywords
- caesarean, uterus
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical balloonDevice
Also called Foley Balloon Catheter
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.
ProstaglandinsDrug
Also called Prostin
Prostin will be used in the control arm.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Balloon | Active comparator | 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. Receives: Device: Cervical balloon |
| Prostaglandin | Active comparator | 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. Receives: Drug: Prostaglandins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Bishops score
Assess for increase in Bishops score from baseline of <5 (Unfavourable) to >6
Measured: 24hours
Secondary outcomes (8)
Achieving active labour
Achieving delivery
Measured: 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
Measured: 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
Measured: Within 24-48hours of intervention
Mode of delivery
Successful vaginal birth after previous caesarean section, or emergency caesarean section
Measured: 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.
Measured: 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.
Measured: Within 24-48hours of intervention
Infectious complications
intrauterine infection, maternal sepsis (e.g. endometritis, UTI), neonatal sepsis, maternal pyrexia, onset of antibiotics
Measured: 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.
Measured: Within 24-48hours of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start29 Aug 2019
- Primary completion27 Aug 2022
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Singapore
- Sponsor type
- Other government
- Collaborators
- Department of Obstetrics and Gynaecology, National University Hospital, Yong Loo Lin School of Medicine, National University Hospital, Singapore, National University of Singapore
- Responsible party
- Principal investigator, Soe-na Choo, Ministry of Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471858
- Sponsor's protocol ID
- 2018/00248
- Other IDs
- 2018
- Acronym
- MEDICS
- Status last verified
- Dec 2025
- First submitted
- 13 Mar 2018
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choo SN, Kanneganti A, Abdul Aziz MNDB, Loh L, Hargreaves C, Gopal V, Biswas A, Chan YH, Ismail IS, Chi C, Mattar C. MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery. BMJ Open. 2019 Nov 6;9(11):e028896. doi: 10.1136/bmjopen-2019-028896.
PubMed 31699720
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEchanical DIlatation of the Cervix in a Scarred Uterus (MEDICS)
- ClinicalTrials.gov ID
- NCT03471858
- Acronym / sponsor ID
- MEDICS / 2018/00248
- Keywords
- caesarean, uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ministry of Health, SingaporeOther government
- Collaborators
- Department of Obstetrics and Gynaecology, National University Hospital, Yong Loo Lin School of Medicine, National University Hospital, Singapore, National University of Singapore
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 27 Aug 2022 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Balloon | Active comparator | Device: Cervical balloonTranscervical 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. |
| Prostaglandin | Active comparator | Drug: ProstaglandinsProstaglandin 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female ≥ 21 years of age at booking visit
- 1 previous uncomplicated lower segment caesarean section (CS)
- Aiming for TOLAC
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
- Singleton pregnancy
Key exclusion criteria (14 listed)
- Refusal to participate
- Women with 2 or more previous CS
- Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery
- Previous uterine surgery with contra-indication to future TOLAC
- Maternal contraindication for vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical balloonAlso: Foley Balloon CatheterTo 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. | Device | Cervical Balloon |
| ProstaglandinsAlso: ProstinProstin will be used in the control arm. | Drug | Prostaglandin |
Primary outcome
Improvement in Bishops score
Time frame: 24hours
Assess for increase in Bishops score from baseline of <5 (Unfavourable) to >6
8 secondary outcomes
Achieving active labour
Time frame: Within 24-48hours of intervention
Number of PGE tablets required
Time frame: Within 24-48hours of intervention
Number of times the foley catheter (cervical balloon) needs to be readjusted
Time frame: Within 24-48hours of intervention
Mode of delivery
Time frame: Within 24-48hours of intervention
Maternal complications
Time frame: Within 24-48hours of intervention
Fetal complications
Time frame: Within 24-48hours of intervention
Infectious complications
Time frame: Within 24-48hours of intervention
Labour complications
Time frame: Within 24-48hours of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 31699720Choo SN, Kanneganti A, Abdul Aziz MNDB, Loh L, Hargreaves C, Gopal V, Biswas A, Chan YH, Ismail IS, Chi C, Mattar C. MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery. BMJ Open. 2019 Nov 6;9(11):e028896. doi: 10.1136/bmjopen-2019-028896.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical balloon and Prostaglandins in people with Pregnancy Related and Labor Complication, run by Ministry of Health, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Bishops score (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.