Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Carevix
DeviceVacuum cervical stabilization device
Tenaculum
DeviceStandard of care cervical stabilization device
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CarevixExperimental treatment 1 intervention
Group B: TenaculumActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient pain score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame
During Procedure (at Cervix Grasping, at Cervix Traction, and at IUD placement)2
Difference in Pain Score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain scores will be compared among nulliparous and multiparous participants
Time frame
Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion3
Highest Pain Score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." The time at which the highest pain score was reported will be compared.
Time frame
Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion4
Expectation of Pain
Participants will be asked to rate their expectation of pain on a scale of 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame
Within 15 minutes after IUD procedure completionSecondary outcomes
1
Provider device satisfaction - Time to Use Device
Providers will be asked to provide their agreement that procedure time was not extended due to the device use on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Time frame
Immediately after IUD procedure2
Provider device satisfaction - Impact on Patient Discomfort
Providers will be asked whether the device's use impacted patient discomfort on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree."
Time frame
Immediately after IUD insertion procedure3
Provider device satisfaction - Device Preference
Providers will be asked to rate their overall satisfaction with the device on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Time frame
Immediately after IUD insertion procedure4
Provider device satisfaction - Procedure Visibility
Providers will be asked to rate visibility while using the device on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Time frame
Immediately after IUD insertion procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Aspivix SA
Collaborator
Source ClinicalTrials.gov