Mechanical Dilation of the Cervix in a Scarred Uterus (MEDICS)
Pregnancy Related, Labor Complication, Cesarean Section; Dehiscence
About this trial
This is an interventional treatment trial for Pregnancy Related focused on measuring caesarean, uterus
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- National University Hospital, SingaporeRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Cervical Balloon
Prostaglandin
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.
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.