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 range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in Bishops score

Timeframe: 24hours

Trial details

NCT IDNCT03471858

SponsorMinistry of Health, Singapore

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-08-27

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