Comparing Pain and Usability of Carevix Suction Device versus Standard Tenaculum for IUD Insertion in Women

What this Trial Is About

Researchers are evaluating patient-reported pain, bleeding, and the efficiency of devices used during intrauterine device IUD insertions. This trial compares a new FDA-approved, atraumatic suction cervical stabilizer called Carevix with the standard single-tooth tenaculum, which is considered more traumatic. The study also looks at provider satisfaction and ease of use for these devices, focusing on differences in pain scores between patients who have never given birth nulliparous and those who have multiparous. Participants will be randomly assigned to receive either the Carevix device or the standard tenaculum during their IUD insertion procedure. Providers will perform the procedures using the assigned device, and participants will complete surveys about their pain experience and satisfaction immediately after the procedure. The study collects additional information on cultural background, previous contraceptive use, and reasons for choosing IUD insertion or anticipating removal. During the trial, participants will be evaluated for pain at several points before the procedure, during cervix grasping and traction, at IUD placement, and five minutes after completion. Providers will assess ease of device use, number of placement attempts, bleeding, and overall satisfaction right after the procedure. Patient satisfaction and bleeding cessation time will also be measured. The study runs from March 2026 to March 2027, with ongoing assessments during and immediately after the IUD insertion.

Assessing Pain and Effectiveness of Carevix Device for IUD Insertions