RECRUITING

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

Description

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

IUD
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Related Conditions:

IUD

Study Overview

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Study Details

Study overview

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.

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

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

Condition
IUD
Intervention / Treatment

-

Contacts and Locations

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oregon Health and Science University,

Julia Tasset, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

2026-04