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

Not Applicable
Not yet recruiting
Conditions
IUD
Registration Number
NCT06891794
Lead Sponsor
Oregon Health and Science University
Brief 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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Successful PlacementImmediately after IUD placement procedure

The number of participants able to correctly place the cap or disc as instructed, assessed by provider

Satisfaction with pain controlImmediately after IUD placement procedure

Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology.

Secondary Outcome Measures
NameTimeMethod
Ease of cap/disc placementImmediately after IUD placement procedure

Participant-reported ease of placement of menstrual cap or disc. Response options will be "very easy", "somewhat easy", "neutral", "somewhat difficult", and "very difficult".

Protocol deviationsImmediately after IUD placement procedure

Provider-reported deviations from the standard protocol including need for additional analgesia, oral pain medication, oral anxiolytic medication, need for cervical dilation, rescheduling with sedation per patient preference, or other.

Ease of IUD placementImmediately after IUD placement procedure

Provider-reported ease of IUD placement with response options "usual", "difficult", or "very difficult"

Procedure complicationsImmediately after IUD placement procedure

Provider-reported complications of IUD placement procedure including vagal reaction, perforation, placement failure, allergic reaction, or other.

Typical menstrual painOn the day of IUD placement procedure prior to cap/disc placement and IUD placement

Patient-reported numerical rating scale of their menstrual pain

Pain during IUD placement procedureMeasured 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

Patient-reported pain using Visual Analog Scale throughout IUD placement procedure

Acceptability of pain mangementone day post-procedure

Patient-reported acceptability of pain management measured by a 5-point Likert scale question. Participants will be asked "How would you rate your satisfaction with the pain control during your IUD placement?". Response options range from very satisfied to very dissatisfied.

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