Abnormal Uterine Bleeding, IUD, Pain, Cervical
Conditions
Keywords
IUD insertion, Cervical Stabilization, Tenaculum, Pain
Brief summary
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
Detailed 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.
Interventions
Sponsors
Indiana University
Aspivix SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Patients will be randomized, but are unable to be blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient pain score | During Procedure (at Cervix Grasping, at Cervix Traction, and at IUD placement) | 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." |
| Difference in Pain Score | Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion | 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 |
| Highest Pain Score | Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion | 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. |
| Expectation of Pain | Within 15 minutes after IUD procedure completion | 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." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider device satisfaction - Time to Use Device | Immediately after IUD procedure | 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" |
| Provider device satisfaction - Impact on Patient Discomfort | Immediately after IUD insertion procedure | Providers will be asked whether the device's use impacted patient discomfort on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree." |
| Provider device satisfaction - Device Preference | Immediately after IUD insertion procedure | Providers will be asked to rate their overall satisfaction with the device on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree" |
| Provider device satisfaction - Procedure Visibility | Immediately after IUD insertion procedure | Providers will be asked to rate visibility while using the device on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree" |
| Provider device satisfaction - Pulling Strength | Immediately after IUD insertion procedure | Providers will be asked to rate the device's pulling strength as adequate on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree" |
| Provider device satisfaction (Ease of Use) | Immediately after IUD procedure | Providers using the Carevix device will be asked to rate ease of use on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree." |
| Number of Device Placement Attempts | Immediately after IUD insertion procedure | Providers are asked to report the number of attempts required for device placement |
| Need for Device Replacement | Immediately after IUD insertion procedure | Providers who use the Carevix device will be asked if the procedure's successful completion required replacing the Carevix device with the cervical tenaculum |
| Provider Reported Bleeding | Immediately after IUD insertion procedure | The number of providers who had to manage or stop bleeding on cervical tissues will be compared. |
| Time to Bleeding Cessation | Immediately after IUD procedure completion | The time (minutes) required for the providers to stop bleeding of cervical tissues will be compared. |
| Patient pain score | Prior to Procedure and 5 minutes after procedure completion | 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." |
| Overall Patient Satisfaction | Immediately after IUD procedure completion | Participants will rate their satisfaction with the procedure on a 5 point Likert scale from 5 point Likert scale from "Strongly Disagree"-"Strongly Agree" |
Countries
United States
Contacts
CONTACTAlissa M Conklin, MD
CONTACTKylie L Williams, MA
PRINCIPAL_INVESTIGATORAlissa M Conklin, MD
Indiana School of Medicine
Outcome results
None listed