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.
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
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
Parallel
Menstrual disc with EMLA cream
Combination productEutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc
Cervical cap with EMLA cream
Combination productEutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc
Successful Placement
The number of participants able to correctly place the cap or disc as instructed, assessed by provider
Satisfaction with pain control
Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology.
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".
Protocol deviations
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
Provider-reported ease of IUD placement with response options "usual", "difficult", or "very difficult"
Procedure complications
Provider-reported complications of IUD placement procedure including vagal reaction, perforation, placement failure, allergic reaction, or other.
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.
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