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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menstrual disc | Experimental | Participants will be provided with a menstrual disc filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the disc. The provider will return to the room, make sure the disc is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the disc or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique. |
|
| Cervical cap | Experimental | Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the cap. The provider will return to the room, make sure the cap is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the cap or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menstrual disc with EMLA cream | Combination Product | Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Placement | The number of participants able to correctly place the cap or disc as instructed, assessed by provider | Immediately after IUD placement procedure |
| Satisfaction with pain control | Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology. | Immediately after IUD placement procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of cap/disc placement | Participant-reported ease of placement of menstrual cap or disc. Response options will be "very easy", "somewhat easy", "neutral", "somewhat difficult", and "very difficult". | Immediately after IUD placement procedure |
| Protocol deviations |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for non-participation | For eligible prospective participants who were approached but declined participation, they will be asked the reason why they chose not to participate. This will be an open-ended response where the study staff member performing the screening will record the reason for declining participation. | During screening/enrollment at the time when an eligible participant declines participation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Department of Ob/Gyn | Contact | 503-494-3666 | whru@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julia Tasset | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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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
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This is an open label study that involves no masking
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| Cervical cap with EMLA cream | Combination Product | Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc |
|
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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. |
| Immediately after IUD placement procedure |
| Ease of IUD placement | Provider-reported ease of IUD placement with response options "usual", "difficult", or "very difficult" | Immediately after IUD placement procedure |
| Procedure complications | Provider-reported complications of IUD placement procedure including vagal reaction, perforation, placement failure, allergic reaction, or other. | Immediately after IUD placement procedure |
| Typical menstrual pain | Patient-reported 11-point Numerical Rating Scale (NRS) of their menstrual pain where 0 represents no pain and 10 represents the worst possible pain. | On the day of IUD placement procedure prior to cap/disc placement and IUD placement |
| Pain during IUD placement procedure | Patient-reported pain using a 100 millimeter Visual Analog Scale (VAS) throughout IUD placement procedure. Participants will mark their level of pain along a 100mm line, where one end (0) represents no pain and the other represents the worst possible pain (100). The distance from the "no pain" end to the participant's mark is measured to provide a numeric representation of pain | 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 | 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 (1) to very dissatisfied (5). | one day post-procedure |
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |