Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
NCT ID: NCT06496854
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2025-10-31
2026-01-31
Brief Summary
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Detailed Description
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Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure.
Secondary endpoints
* Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants.
* Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales
* Discuss participant's experiences with taking lorazepam and participating in the study
* Assess investigator's experience with the trial via a focus group
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Lorazepam administration prior to IUD insertion procedure
Lorazepam 1 mg
1 mg oral lorazepam, a sedative used to relieve anxiety
Ibuprofen 800 mg
800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain
Interventions
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Lorazepam 1 mg
1 mg oral lorazepam, a sedative used to relieve anxiety
Ibuprofen 800 mg
800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain
Eligibility Criteria
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Inclusion Criteria
* Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
* Participants must have a driver take them home after the procedure as well.
* Participants must consent to email communication since they will sign the consent forms electronically
Exclusion Criteria
* Participants who receive cervical blocks or other analgesic method during IUD insertion.
* Participants who have a history of substance use disorder.
* Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
* Participants who are not able to sign an electronic consent form.
* Participants who do not have a driver to take them to their appointment and to take them home after the procedure.
* Participants who do not agree to sign consent forms electronically.
18 Years
FEMALE
Yes
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Jensena Carlson, MD
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Locations
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UW Family Medicine Residency Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A532014
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 6/5/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2024-0655
Identifier Type: -
Identifier Source: org_study_id
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