Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE) (NCT07288021) | Clinical Trial Compass
RecruitingPhase 4
Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
Israel200 participantsStarted 2024-02-05
Plain-language summary
The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals.
All participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery.
Investigators seek to compare pain levels and patient satisfaction between two groups:
Nulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.
Who can participate
Age range
18 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:
* Women scheduled for labor induction with balloon catheter.
* 18 years of age or older.
* Singleton pregnancy with a cephalic presentation.
* ≥ 34 completed gestational weeks.
* Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes.
* No contraindication for vaginal delivery
Exclusion Criteria:
* Unable or unwilling to provide and sign informed consent forms.
* Known sensitivity to EMLA or placebo substance.
* Known vulvodynia or vaginismus - rendering vaginal examination not possible.
* Any chronic pain syndrome
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
1
Pain levels during insertion
Timeframe: directly after application and insertion of balloon catheter.