Mechanical Dilation of the Cervix in a Scarred Uterus (NCT03471858) | Clinical Trial Compass
CompletedNot Applicable
Mechanical Dilation of the Cervix in a Scarred Uterus
Singapore44 participantsStarted 2019-08-29
Plain-language 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).
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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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
* …