Actively Recruiting
Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion
Led by Oregon Health and Science University · Updated on 2025-08-08
24
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc. Twenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.
CONDITIONS
Official Title
Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 requiring daily medication
- History of endometriosis, fibroids, adenomyosis, or prior cervical procedures such as LEEP or cold knife cone
- Any contraindications to IUD placement including pregnancy, fibroids distorting the uterine cavity, pelvic inflammatory disease, allergy to LNG-IUS components
- Known allergy to 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
- Weight less than 54.4 kg (120 lbs)
- Planned use of oral anxiolysis, moderate/deep sedation, or narcotics for the procedure
- Recent use (past 24 hours) of oral anxiolysis, moderate/deep sedation, or narcotics
- Any planned concomitant procedures such as D&C, endometrial biopsy, colposcopy, hysteroscopy
- Illicit drug use
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Department of Ob/Gyn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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