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
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 (Numeric Pain Rating Scale)
0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame
During IUD insertion procedureSecondary outcomes
1
Provider device satisfaction
Questionnaire
Time frame
Immediately after IUD insertion procedure2
Reason for IUD procedure
Questionnaire
Time frame
Immediately after IUD insertion procedureOther outcomes
1
Predictors for pain score
Questionnaire
Time frame
Immediately after IUD insertion procedure2
Patient pain score at device placement, prior to IUD insertion (Numeric Pain Rating Scale)
0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame
During IUD insertion procedure3
Patient pain score after completion of IUD insertion procedure (Numeric Pain Rating Scale)
0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
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
This trial is not recruiting at the moment. You can still explore other options: