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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06891794
Status
Recruiting
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Conditions

  • IUD

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Menstrual disc with EMLA cream — COMBINATION_PRODUCT
    Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc
  • Cervical cap with EMLA cream — COMBINATION_PRODUCT
    Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Menstrual disc
    Participants will be provided with a menstrual disc filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the disc. The provider will return to the room, make sure the disc is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the disc or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.
  • Experimental: Cervical cap
    Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the cap. The provider will return to the room, make sure the cap is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the cap or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.

Primary Outcome Measure

Successful Placement [ Time Frame: Immediately after IUD placement procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Women's Health Research Unit
[email protected]
503-494-3666

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By research site
Oregon Health & Science University· Portland, OR

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