Status:
COMPLETED
Mechanical Dilation of the Cervix in a Scarred Uterus
Lead Sponsor:
Ministry of Health, Singapore
Collaborating Sponsors:
Department of Obstetrics and Gynaecology, National University Hospital
Yong Loo Lin School of Medicine
Conditions:
Pregnancy Related
Labor Complication
Eligibility:
FEMALE
18-50 years
Phase:
NA
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).
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03471858
Start Date
August 29 2019
End Date
August 16 2025
Last Update
December 15 2025
Active Locations (1)
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1
National University Hospital, Singapore
Singapore, Singapore, 679973