Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
Recruiting
Phase 4
Interventional Study
Labor, Induced
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Bnai Zion Medical Center · Government
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 …
Contacts