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
Trial Information
Current as of April 29, 2025
Not yet recruiting
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
About Oregon Health And Science University
Oregon Health and Science University (OHSU) is a leading academic medical center dedicated to advancing health through research, education, and patient care. As a prominent sponsor of clinical trials, OHSU leverages its extensive expertise in various medical fields to facilitate innovative research aimed at improving patient outcomes. The institution is committed to ethical standards and rigorous scientific methodologies, fostering collaborations that enhance the development of new therapies and interventions. With a focus on translating research discoveries into clinical practice, OHSU plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported