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NCT07290517
Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
Conditions: IUD, Abnormal Uterine Bleeding, Pain, Cervical
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Indiana University
Location: Indiana University Hospital Indianapolis Indiana
Summary
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07290517). StuddyBuddy aggregates publicly available trial information.