Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how well two different methods of applying a numbing cream work before getting an intrauterine device (IUD) placed. The study will involve women who are planning to have an IUD inserted without any sedation (medication to help you relax) at the Center for Women’s Health. Participants will use either a menstrual disc or a cervical cap to apply a topical anesthetic cream right before the procedure.

To be eligible for this study, women must be healthy, able to read and sign consent forms in English, and scheduled for an IUD placement. However, those who have had certain medical issues, like previous pregnancies or specific pelvic conditions, cannot participate. If you join the study, you will be randomly assigned to one of the two methods for applying the numbing cream. The goal is to see if these methods can help reduce discomfort during the IUD insertion process, making it easier for women to get this form of birth control.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic
• • Able to review and sign study consents in English
• • Generally healthy
• Exclusion Criteria:
• • History of any prior births, miscarriages, or abortions after 16 weeks' gestation
• • Currently pregnant, known or suspected
• • Current stringless IUD in place
• • Participants premedicated with misoprostol
• • History of chronic pelvic pain which patients take daily medication for
• • History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)
• • Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)
• • Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap
• • Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap
• • Previous IUD placement or failed attempt of an IUD placement
• • Weight \< 54.4kg (120 lbs)
• • Plan for use of oral anxiolysis, moderate/deep sedation, or narcotics for procedure
• • Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate/deep sedation, or narcotics
• • Any planned concomitant procedures, such as dilation and curettage (D\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.
• • Illicit drug use