RecruitingNot ApplicableNCT06891794

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

Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion

Sponsor

Oregon Health and Science University

Enrollment

24 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

IUD

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 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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

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 Criteria15

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