Topical numbing cream for balloon-catheter cervical ripening
Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
This trial will test whether applying a numbing cream (lidocaine‑prilocaine, EMLA) to the perineum and posterior vaginal wall before balloon catheter insertion reduces pain for people 34+ weeks pregnant who need labor induction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Bnai Zion Medical Center Government |
| Locations | 1 site (Haifa) |
| Trial ID | NCT07288021 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double‑blind, placebo‑controlled trial comparing topical lidocaine‑prilocaine cream (EMLA) versus a placebo applied to the perineum and posterior vaginal wall before balloon catheter insertion for cervical ripening. Participants are pregnant individuals aged 18 or older with a singleton cephalic pregnancy at 34+ weeks who are scheduled for induction with a balloon catheter and have no contraindication to vaginal delivery. Pain levels during catheter insertion and patient satisfaction will be measured and compared between EMLA and placebo groups, with analyses performed separately for nulliparous and multiparous participants. The trial is conducted at Bnai Zion Medical Center in Haifa, Israel.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 18+ with a singleton cephalic fetus at ≥34 weeks scheduled for induction using a balloon catheter who can provide informed consent and have no allergy to lidocaine‑prilocaine.
Not a fit: Those with known sensitivity to lidocaine‑prilocaine, vulvodynia or vaginismus that prevents vaginal exam, chronic pain syndromes, or who are not undergoing balloon‑catheter induction are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce pain and improve satisfaction during balloon‑catheter cervical ripening and may lower the need for additional analgesia at the time of insertion.
How similar studies have performed: Topical lidocaine‑prilocaine has shown benefit for some minor vaginal and cervical procedures, but its use specifically for reducing pain during balloon catheter insertion for induction is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Haifa
- Bnai Zion Medical Center — Haifa, Israel (Recruiting)
Study contacts
- Study coordinator: Dafna Ben Yehuda Raz, MD, resident doctor
- Email: dafna.ben-yehuda@b-zion.org.il
- Phone: +97248359366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.