Topical numbing cream for balloon-catheter cervical ripening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.