[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06891794":3,"trial-entities:NCT06891794":131,"trial-summary:NCT06891794":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":54,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":15,"eligibility_criteria":82,"std_ages":104,"locations":106,"central_contacts":122,"overall_officials":125,"references":129,"see_also_links":130},"NCT06891794","OHSU IRB 28118","Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion","Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion","RECRUITING","2026-04","2025-08","2025-08-08","2025-08-04","Oregon Health and Science University","OTHER",false,"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.\n\nTwenty-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\u002Fdisc will be removed, and the provider will proceed with the IUD insertion according to manufacturer technique.\n\nVisual 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.",[19],"IUD",[21,22],"Topical Anesthetic","IUD Insertion","INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},24,"ESTIMATED",[31,40],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"COMBINATION_PRODUCT","Menstrual disc with EMLA cream","Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc",[36],"Menstrual disc",[38,39],"2.5% prilocaine-2.5% lidocaine cream","Softdisc",{"type":32,"name":41,"description":34,"armGroupLabels":42,"otherNames":44},"Cervical cap with EMLA cream",[43],"Cervical cap",[45,38],"FemCap",[47,51],{"measure":48,"description":49,"timeFrame":50},"Successful Placement","The number of participants able to correctly place the cap or disc as instructed, assessed by provider","Immediately after IUD placement procedure",{"measure":52,"description":53,"timeFrame":50},"Satisfaction with pain control","Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology.",[55,58,61,64,67,71,75],{"measure":56,"description":57,"timeFrame":50},"Ease of cap\u002Fdisc 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\".",{"measure":59,"description":60,"timeFrame":50},"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.",{"measure":62,"description":63,"timeFrame":50},"Ease of IUD placement","Provider-reported ease of IUD placement with response options \"usual\", \"difficult\", or \"very difficult\"",{"measure":65,"description":66,"timeFrame":50},"Procedure complications","Provider-reported complications of IUD placement procedure including vagal reaction, perforation, placement failure, allergic reaction, or other.",{"measure":68,"description":69,"timeFrame":70},"Typical menstrual pain","Patient-reported 11-point Numerical Rating Scale (NRS) of their menstrual pain where 0 represents no pain and 10 represents the worst possible pain.","On the day of IUD placement procedure prior to cap\u002Fdisc placement and IUD placement",{"measure":72,"description":73,"timeFrame":74},"Pain during IUD placement procedure","Patient-reported pain using a 100 millimeter Visual Analog Scale (VAS) throughout IUD placement procedure. Participants will mark their level of pain along a 100mm line, where one end (0) represents no pain and the other represents the worst possible pain (100). The distance from the \"no pain\" end to the participant's mark is measured to provide a numeric representation of pain","Measured throughout IUD placement procedure immediately before the procedure, during placement of disc\u002Fcap, during speculum placement, during tenaculum placement, during sounding, during IUD placement, and 5 minutes after completion",{"measure":76,"description":77,"timeFrame":78},"Acceptability of pain mangement","Patient-reported acceptability of pain management measured by a 5-point Likert scale question. Participants will be asked \"How would you rate your satisfaction with the pain control during your IUD placement?\". Response options range from very satisfied (1) to very dissatisfied (5).","one day post-procedure","FEMALE","18 Years","45 Years",{"inclusion":83,"exclusion":87,"raw_text":103},[84,85,86],"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",[88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"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 \\\u003C 54.4kg (120 lbs)","Plan for use of oral anxiolysis, moderate\u002Fdeep sedation, or narcotics for procedure","Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate\u002Fdeep sedation, or narcotics","Any planned concomitant procedures, such as dilation and curettage (D\\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.","Illicit drug use","Inclusion Criteria:\n\n* Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic\n* Able to review and sign study consents in English\n* Generally healthy\n\nExclusion Criteria:\n\n* History of any prior births, miscarriages, or abortions after 16 weeks' gestation\n* Currently pregnant, known or suspected\n* Current stringless IUD in place\n* Participants premedicated with misoprostol\n* History of chronic pelvic pain which patients take daily medication for\n* History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)\n* 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.)\n* Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap\n* Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap\n* Previous IUD placement or failed attempt of an IUD placement\n* Weight \\\u003C 54.4kg (120 lbs)\n* Plan for use of oral anxiolysis, moderate\u002Fdeep sedation, or narcotics for procedure\n* Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate\u002Fdeep sedation, or narcotics\n* Any planned concomitant procedures, such as dilation and curettage (D\\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.\n* Illicit drug use",[105],"ADULT",[107],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":119},"Oregon Health & Science University","Portland","Oregon","97239","United States",[114],{"name":115,"role":116,"phone":117,"email":118},"Women's Health Research Unit","CONTACT","503-494-3666","whru@ohsu.edu",{"lat":120,"lon":121},45.52345,-122.67621,[123],{"name":124,"role":116,"phone":117,"email":118},"Women's Health Research Unit Department of Ob\u002FGyn",[126],{"name":127,"affiliation":13,"role":128},"Julia Tasset","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":132,"biomarkers":134},[133],"Contraception",[],{"nct_id":4,"found":136,"summary":137,"prompt_version":147},true,{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is an open-label study, meaning you and your doctor will know which treatment you receive. It will involve 24 participants, with 12 receiving EMLA cream via a menstrual disc and 12 via a cervical cap.","completed","Topical Anesthetic for IUD Insertion Study","This study is looking at whether using a topical anesthetic (pain-numbing cream called EMLA cream) applied with either a menstrual disc or a cervical cap can help reduce pain during an IUD (intrauterine device) insertion. You might be able to join if you are a woman between 18 and 45 years old, are generally healthy, and are scheduled for an IUD placement at the Center for Women's Health. The study aims to see if these methods successfully place the IUD and if participants are satisfied with their pain control immediately after the procedure. This study is currently recruiting 24 participants.","Your satisfaction with pain control and successful IUD placement will be measured immediately after the procedure.",100,"You would self-administer the EMLA cream using a menstrual disc or cervical cap before your IUD insertion. Your pain levels will be assessed during and immediately after the procedure.","Not stated in the trial record.",[],"v2"]