Pain relief for cervical ripening balloon during labor induction
Official title: Randomized Control Trial for Pain Control With Topical Lidocaine for Cervical Ripening Balloon Placement
Run by Beth Israel Deaconess Medical Center · NCT07268118 · Data updated 2026-11-12
This study tests whether applying lidocaine gel inside the vagina can reduce pain from placing a cervical ripening balloon for women undergoing labor induction.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 110 (estimated) |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 13, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT07268118 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older at or beyond 37 weeks gestation with viable pregnancies planning cervical ripening balloon placement and able to consent.
✕Probably not a fit
Patients with lidocaine allergy or who have neuraxial anesthesia during induction may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial seeks to determine if vaginal lidocaine gel can lessen the pain associated with cervical ripening balloon placement during induction of labor. Eligible participants are adults 18 or older with a viable, English-speaking pregnancy at 37 weeks or more, planning cervical ripening balloon placement. The intervention involves topical vaginal lidocaine gel; no neuraxial anesthesia is allowed approaches concurrently. The study is conducted at Beth Israel Deaconess Medical Center in Boston, with a lead sponsor and no listed collaborators.
Why it matters
Potential benefit: If successful, participants may experience less pain during cervical ripening balloon placement.
How similar studies have gone: Prior similar approaches in pain management for cervical procedures have shown promise, but this exact method for cervical ripening balloon placement is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Gestational age ≥37 weeks * Viable pregnancy * Intact membranes * English speaking * Interested in cervical ripening balloon placement * Able to provide consent Exclusion Criteria: * Allergy or sensitivity to lidocaine * Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural) * Known uterine or cervical anomalies
Where it's running
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Sarah Little, MD
- Email: slittl10@bidmc.harvard.edu
- Phone: 6176677000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.