Clinical trial NCT06891794: Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion
Official title: Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: IUD
Keywords: Topical Anesthetic
IUD Insertion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two arms (menstrual disc or cervical cap) for eutectic mixture of local anesthetics (EMLA) cream application prior to intrauterine device (IUD) insertion
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Successful Placement
timeFrame: Immediately after IUD placement procedure
measure: Satisfaction with pain control
timeFrame: Immediately after IUD placement procedure
Secondary outcomes:
measure: Ease of cap/disc placement
timeFrame: Immediately after IUD placement procedure
measure: Protocol deviations
timeFrame: Immediately after IUD placement procedure
measure: Ease of IUD placement
timeFrame: Immediately after IUD placement procedure
measure: Procedure complications
timeFrame: Immediately after IUD placement procedure
measure: Typical menstrual pain
timeFrame: On the day of IUD placement procedure prior to cap/disc placement and IUD placement
measure: Pain during IUD placement procedure
timeFrame: 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
measure: Acceptability of pain mangement
timeFrame: one day post-procedure
Other outcomes:
measure: Reasons for non-participation
timeFrame: During screening/enrollment at the time when an eligible participant declines participation
Locations:
Study officials:
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