Status:
RECRUITING
Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion
Lead Sponsor:
Oregon Health and Science University
Conditions:
IUD
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center ...
Detailed Description
Nulliparous patients undergoing IUD insertion will administer EMLA cream by menstrual disc or cervical cap prior to insertion. The medical provider will ensure proper placement of the cap or disc and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06891794
Start Date
August 4 2025
End Date
April 1 2026
Last Update
August 8 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239