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New treatment option for Labor, Induced
Official title Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
ClinicalTrials.gov ID: NCT07288021
What this study is testing
What is Topical Analgesia with Lidocaine-Prilocaine cream?
Topical Analgesia with Lidocaine-Prilocaine cream is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for labor, induced.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Haifa, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haifa, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.