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

RecruitingNAAges 18 Years - 45 YearsFemaleOregon Health and Science University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Menstrual disc with EMLA cream
  • Cervical cap with EMLA cream
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Where

1 site
Oregon Health & Science University
Portland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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