IUD
Conditions
Keywords
Topical Anesthetic, IUD Insertion
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.
Interventions
COMBINATION_PRODUCTMenstrual disc with EMLA cream
Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc
COMBINATION_PRODUCTCervical cap with EMLA cream
Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open label study that involves no masking
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with pain control | Immediately after IUD placement procedure | Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology. |
| Successful Placement | Immediately after IUD placement procedure | The number of participants able to correctly place the cap or disc as instructed, assessed by provider |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of cap/disc placement | Immediately 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 deviations | Immediately 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 placement | Immediately after IUD placement procedure | Provider-reported ease of IUD placement with response options usual, difficult, or very difficult |
| Typical menstrual pain | On the day of IUD placement procedure prior to cap/disc placement and IUD placement | Patient-reported 11-point Numerical Rating Scale (NRS) of their menstrual pain where 0 represents no pain and 10 represents the worst possible pain. |
| Pain during IUD placement procedure | 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 | 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 |
| Procedure complications | Immediately after IUD placement procedure | Provider-reported complications of IUD placement procedure including vagal reaction, perforation, placement failure, allergic reaction, or other. |
| Acceptability of pain mangement | one 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 (1) to very dissatisfied (5). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reasons for non-participation | During screening/enrollment at the time when an eligible participant declines 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. |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Department of Ob/Gyn
Outcome results
None listed