Mechanical Dilation of the Cervix in a Scarred Uterus

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ministry of Health, Singapore
• Collaborators: Department of Obstetrics and Gynaecology, National University Hospital; National University Hospital, Singapore; National University, Singapore; Yong Loo Lin School of Medicine

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