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
Sub Specialties:

Contact Information

Amy Orr
amy.orr@hsc.utah.edu
801-213-2774

Brief Summary

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.

Inclusion Criteria

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

 

Exclusion Criteria

Exclusion Criteria:

·Post-menopausal

·Current pregnancy

·Cervical abnormalities (cervical polyp, cervical lesion, or irregularity)

·Use of narcotics or Benzodiazepines prior to procedure