Mechanical Dilation of the Cervix in a Scarred Uterus

NCT03471858 | Completed DMC

• 1 other identifier: 2018/00248
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pregnancy Related; Labor Complication; Cesarean Section; Dehiscence

Keywords

caesarean, uterus

Outcome Measures

Primary Outcomes (1)

• Improvement in Bishops score

  Assess for increase in Bishops score from baseline of \<5 (Unfavourable) to \>6

  24hours

Secondary Outcomes (8)

• Achieving active labour

  Within 24-48hours of intervention

• Number of PGE tablets required

  Within 24-48hours of intervention

• Number of times the foley catheter (cervical balloon) needs to be readjusted

  Within 24-48hours of intervention

• Mode of delivery

  Within 24-48hours of intervention

• Maternal complications

  Within 24-48hours of intervention

Study Arms (2)

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.

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.

Drug: Prostaglandins

Interventions

Cervical balloon DEVICE

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

Cervical Balloon

Prostaglandins DRUG

Prostin will be used in the control arm.

Also known as: Prostin

Prostaglandin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female ≥ 21 years of age at booking visit
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ministry of Health, Singapore: lead
• Department of Obstetrics and Gynaecology, National University Hospital: collaborator
• Yong Loo Lin School of Medicine: collaborator
• National University Hospital, Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital, Singapore

Singapore, 679973, Singapore

Location

Related Publications (1)

• 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.

  PMID: 31699720 DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Prostaglandins; KLK15 protein, human

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 21, 2018
• Study Start: August 29, 2019
• Primary Completion: August 27, 2022
• Study Completion: August 16, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)