About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Menstrual disc with EMLA cream
- Cervical cap with EMLA cream