About this trial
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
Qualifiers
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
Disqualifiers
Vaginal bleeding of unknown origin
Cervix less than 26 mm in diameter
Nabothian cyst on anterior lip of cervix
Cervical myomas
Trial design
Treatments tested in this trial
- Carevix
- Tenaculum
Treatment groups
Sponsors and collaborators
Indiana University
Lead sponsor
Aspivix SA
Collaborator