Assessing Pain and Effectiveness of Carevix Device for IUD Insertions (CARE)

Indiana University

Status: Not yet enrolling

Conditions: Pain, Cervical; Abnormal Uterine Bleeding; IUD

Treatments: Device: Carevix; Device: Tenaculum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07290517

25731

Details and patient eligibility

About

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

Full description

The primary objective is to assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum. The hypothesis is that patient-reported pain scores comparing Carevix™ to tenaculum will be lower. The investigators will assess pain, and predictors for pain scores including nulliparous vs multiparous, when highest pain scores are reported, and expectation of pain for the procedure.

The secondary objective will be to assess Usability (provider assessment of ease of use, number of device placement attempts to secure sufficient traction on uterus), efficacy (ability to insert IUD with Carevix™ device alone without recourse to conventional tenaculum or other instruments), provider reported bleeding (cervical bleeding and ecchymosis), overall provider satisfaction, patient-reported pain scores at device placement prior to IUD insertion procedure and after completion of IUD insertion using Visual Analog Scale (VAS), overall patient satisfaction, and overall provider satisfaction. The investigators aim to expand the pilot trial data collection to assess cultural background, ethnicity and demographics while also assessing prior contraceptive choices, reasons for discontinuation of prior choices and reasons for current selection of IUD insertion and any anticipated barriers for removal.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Carevix

Experimental group

Description:

Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.

Treatment:

Device: Carevix

Tenaculum

Active Comparator group

Description:

Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.

Treatment:

Device: Tenaculum