Actively Recruiting
Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
Led by Bnai Zion Medical Center · Updated on 2025-12-17
200
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women scheduled for labor induction with balloon catheter.
- 18 years of age or older.
- Singleton pregnancy with a cephalic presentation.
- 65 34 completed gestational weeks.
- Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes.
- No contraindication for vaginal delivery
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Bnai Zion Medical Center
Haifa, Israel, 3339419
Actively Recruiting
Research Team
D
Dafna Ben Yehuda Raz, MD, resident doctor
CONTACT
I
Inna Bleicher, MD, MFM specialist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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