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Recruiting NCT06891794

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

No phase Interventional IUD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Menstrual disc with EMLA cream, Cervical cap with EMLA cream.
Who it may be relevant to
Registry conditions: IUD. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Detailed description

Nulliparous patients undergoing IUD insertion will administer EMLA cream by menstrual disc or cervical cap prior to insertion. The medical provider will ensure proper placement of the cap or disc and perform a bi-manual exam to assess the patient's uterine position. A seven minute timer will be set, the cap/disc will be removed, and the provider will proceed with the IUD insertion according to manufacturer technique.

Visual Analog Scale (VAS) scores will be used throughout the procedure to assess participant pain throughout insertion. Participants and providers will report on pain, side effects, and procedure complications immediately after the procedure.

Interventions

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

Primary outcome measures

  • Successful Placement [Time frame: Immediately after IUD placement procedure]
  • Satisfaction with pain control [Time frame: Immediately after IUD placement procedure]
Secondary outcome measures (7)
  • Ease of cap/disc placement [Time frame: Immediately after IUD placement procedure]
  • Protocol deviations [Time frame: Immediately after IUD placement procedure]
  • Ease of IUD placement [Time frame: Immediately after IUD placement procedure]
  • Procedure complications [Time frame: Immediately after IUD placement procedure]
  • Typical menstrual pain [Time frame: On the day of IUD placement procedure prior to cap/disc placement and IUD placement]
  • Pain during IUD placement procedure [Time frame: Measured throughout IUD placement procedure immediately before the procedure, during placement of disc/cap, during speculum placement, during tenaculum placement, during sounding, during IUD placement, and 5 minutes after completion]
  • Acceptability of pain mangement [Time frame: one day post-procedure]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT06891794 · OHSU IRB 28118

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗