Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIndiana University

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

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

Aspivix SA

Collaborator