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

Oregon Health and Science University24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

IUD

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Successful Placement

The number of participants able to correctly place the cap or disc as instructed, assessed by provider