Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID06891794

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

Led by Oregon Health and Science University · Updated on 2025-08-08

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This study involves nulliparous women planning to have an intrauterine device (IUD) placed without sedation or anxiety medication at the Center for Women's Health. The research aims to evaluate two methods of applying a topical anesthetic cream, EMLA, using either a menstrual disc or a cervical cap, to reduce pain during IUD insertion. The study is open label, randomized, and designed to assess the feasibility of these application methods. Participants will be randomly assigned to one of two groups: one group will self-administer 5g of EMLA cream using a menstrual disc, and the other group will use a cervical cap filled with the same anesthetic cream. Study staff will ensure proper placement of the disc or cap, set a seven-minute timer, and then remove the device before the provider inserts the IUD according to manufacturer instructions. There are 12 participants in each group. Throughout the procedure, pain will be measured using a Visual Analog Scale (VAS), and both participants and providers will report on pain levels, side effects, and any complications immediately after the procedure. Additional outcomes include ease of device placement, protocol deviations, menstrual pain before the procedure, and acceptability of pain management one day after. The study will monitor successful IUD placement and satisfaction with pain control, and participation will last through the procedure and immediate post-procedure assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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 treated with 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, uterine fibroids that distort the cavity, pelvic inflammatory disease, or allergy to components of the levonorgestrel intrauterine system
  • 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 procedure
  • Recent use (past 24 hours) of oral anxiolysis, moderate/deep sedation, or narcotics
  • Planned additional procedures such as dilation and curettage, endometrial biopsy, colposcopy, or hysteroscopy
  • Illicit drug use

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants will self-administer EMLA cream using either a menstrual disc or cervical cap prior to IUD insertion. A medical provider will confirm proper placement and set a seven minute timer before removal of the disc or cap and subsequent IUD insertion.

1 visit (in-person)

Follow-up

Duration - Up to 1 day after procedure

Participants and providers report on pain, side effects, and procedure complications immediately after the IUD insertion procedure. Additional acceptability of pain management is assessed one day post-procedure.

1 visit (in-person) and 1 follow-up contact (in-person or remote)

Trial Site Locations

Total: 1 location

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

W

Women's Health Research Unit Department of Ob/Gyn

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Frequently Asked Questions

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