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Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

RecruitingNAAges 18 Years - anyFemaleIndiana University
NCT07290517 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between IUD insertions using a suction cervical stabilizer (new device, FDA approved, atraumatic) and single-tooth tenaculum (standard, traumatic). Our aims are to: * assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum. * assess predictors of pain scores including between nulliparous and multiparous patients * assess provider-reported ease of use and satisfaction Participants (including providers) will: * be randomized to receive one device to complete the IUD procedure * complete a survey following the procedure

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📋 Eligibility rules (as published)
Inclusion Criteria (to be assessed prior to procedure): * Age 18 years or older * Able to consent on their own * Scheduled and will undergo an IUD insertion within 90 days of consent * Planned use of cervical stabilization device for placement * Procedure being performed by a trained provider * Provider is willing to use Carevix™ for scheduled procedure Exclusion Criteria (to be assessed by provider at time of procedure): * Vaginal bleeding of unknown origin * Cervix less than 26 mm in diameter * Nabothian cyst on anterior lip of cervix * Cervical myomas * Cervical abnormalities/shape * Pregnant * Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language * Other inability to provide informed consent to participate * Initial attempt to place the IUD without any cervical stabilization
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What it tests

  • Carevix
  • Tenaculum
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Where

1 site
Indiana University Hospital
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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