Novel Cervical Retraction Device
|Principal Investigator: DavidTurok|
|Keywords: device for IUD insertion||Department: DFPM-Family Practice|
|IRB Number: 00070910||Co Investigator: DavidTurok|
|Specialty: Women and Children's Health|
This study will test a suction-based method of engaging the cervix.
The study has four aims.
Aim #1: To observe and measure a patient’s reaction and perception to the application of the Bioceptive Cervical Retractor.
Aim #2: To measure the pain perceptions of the Bioceptive Cervical Retractor versus the single-toothed cervical tenaculum and the atraumatic tenaculum.
Aim #3: To assess copper T380 IUD placement efficacy and participant assessment of pain using the retractor and BII.
Aim #4: To assess copper T380 IUD placement efficacy and participant assessment of pain using the BII versus standard IUD insertion instruments.
There are four phases of the study and inclusion and exclusion criteria are the same for all phases.
Inclusion Criteria are:
·Subjects presenting for IUD insertion (Phase 3-4 copper T380 IUD only)
·Age 18 - 45
·Able to consent for study in English or Spanish
·Cervical abnormalities (cervical polyp, cervical lesion, or irregularity)
·Use of narcotics or Benzodiazepines prior to procedure