Study of Topical Anesthetic Cream to Reduce Pain During Balloon Catheter Insertion for Labor Induction in Pregnant Women

What this Trial Is About

Researchers are evaluating whether applying a topical anesthetic cream to the perineum and the posterior wall of the vagina before inserting a balloon catheter for labor induction can reduce pain in pregnant individuals. This study focuses on women aged 18 or older, with a single baby in head-down position, who are late-preterm or term 34 weeks gestation or more and require labor induction without any contraindications for vaginal delivery. The study compares pain levels and patient satisfaction between groups of first-time mothers and those who have given birth before, using either an anesthetic cream or a placebo. Participants will receive either the topical analgesic cream lidocaine-prilocaine, known as EMLA or a placebo cream applied by the doctor to the perineum, posterior fourchette, and posterior vaginal wall before balloon catheter insertion. Three puffs of the cream are applied, followed by a 7-minute pause to allow the cream to take effect. The study is randomized and double-blinded, meaning neither the participants nor the doctors know which cream is being used. During the study, participants will be asked about their pain levels immediately after balloon catheter insertion and removal, as well as their satisfaction and willingness to undergo the procedure again. Researchers will also monitor pain relief while the catheter is in place, pain during delivery, mode of delivery, newborn health measures including weight, APGAR score, and cord blood gas, as well as any neonatal complications or admissions to intensive care. The insertion procedure duration and difficulty will be recorded, along with any obstetric trauma. The study aims to understand the effects of the topical anesthetic cream on pain and overall birth outcomes.

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)