Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion

ConditionIUD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorOregon Health and Science University

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

Treatment groups

24 Participants
are divided into 2 treatment groups