Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

Official title

The Carevix Device: Assessing Pain and Effectiveness of a Suction-based Cervical Stabilizer for IUD Insertions in the Clinic Setting: a Randomized, Controlled Trial (CARE)

Overview

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

• Device Carevix
  Vacuum cervical stabilization device
• Device Tenaculum
  Standard of care cervical stabilization device

Primary outcome measures

• Patient pain score [Time frame: During Procedure (at Cervix Grasping, at Cervix Traction, and at IUD placement)]
• Difference in Pain Score [Time frame: Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion]
• Highest Pain Score [Time frame: Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion]
• Expectation of Pain [Time frame: Within 15 minutes after IUD procedure completion]

Secondary outcome measures (12)

• Provider device satisfaction - Time to Use Device [Time frame: Immediately after IUD procedure]
• Provider device satisfaction - Impact on Patient Discomfort [Time frame: Immediately after IUD insertion procedure]
• Provider device satisfaction - Device Preference [Time frame: Immediately after IUD insertion procedure]
• Provider device satisfaction - Procedure Visibility [Time frame: Immediately after IUD insertion procedure]
• Provider device satisfaction - Pulling Strength [Time frame: Immediately after IUD insertion procedure]
• Provider device satisfaction (Ease of Use) [Time frame: Immediately after IUD procedure]
• Number of Device Placement Attempts [Time frame: Immediately after IUD insertion procedure]
• Need for Device Replacement [Time frame: Immediately after IUD insertion procedure]
• Provider Reported Bleeding [Time frame: Immediately after IUD insertion procedure]
• Time to Bleeding Cessation [Time frame: Immediately after IUD procedure completion]
• Patient pain score [Time frame: Prior to Procedure and 5 minutes after procedure completion]
• Overall Patient Satisfaction [Time frame: Immediately after IUD procedure completion]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Indiana University Hospital — Indianapolis

Publications

• Yaron M, Legardeur H, Barcellini B, Akhoundova F, Mathevet P. Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Contraception. 2023 Jul;123:110004. doi: 10.1016/j.contraception.2023.110004. Epub 2023 Mar 11. PMID 36914147

Identifiers

NCT: NCT07290517 · 25731

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗