NCT07288021 Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
| NCT ID | NCT07288021 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bnai Zion Medical Center |
| Condition | Labor, Induced |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-02-05 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07288021 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Labor, Induced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07288021 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07288021 currently recruiting?
Yes, NCT07288021 is actively recruiting participants. Contact the research team at dafna.ben-yehuda@b-zion.org.il for enrollment information.
Where is the NCT07288021 trial being conducted?
This trial is being conducted at Haifa, Israel.
Who is sponsoring the NCT07288021 clinical trial?
NCT07288021 is sponsored by Bnai Zion Medical Center. The trial plans to enroll 200 participants.