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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient pain score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Patients will be randomized, but are unable to be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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
- •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
研究组 & 干预措施
Tenaculum
Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.
干预措施: Tenaculum (Device)
Carevix
Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.
干预措施: Carevix (Device)
结局指标
主要结局
Patient pain score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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."
Patient pain score (Numeric Pain Rating Scale)
时间窗: During IUD insertion procedure
0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
次要结局
- Provider device satisfaction - Time to Use Device(Immediately after IUD procedure)
- Provider device satisfaction - Impact on Patient Discomfort(Immediately after IUD insertion procedure)
- Provider device satisfaction - Device Preference(Immediately after IUD insertion procedure)
- Provider device satisfaction - Procedure Visibility(Immediately after IUD insertion procedure)
- Provider device satisfaction - Pulling Strength(Immediately after IUD insertion procedure)
- Provider device satisfaction (Ease of Use)(Immediately after IUD procedure)
- Number of Device Placement Attempts(Immediately after IUD insertion procedure)
- Need for Device Replacement(Immediately after IUD insertion procedure)
- Provider Reported Bleeding(Immediately after IUD insertion procedure)
- Time to Bleeding Cessation(Immediately after IUD procedure completion)
- Patient pain score(Prior to Procedure and 5 minutes after procedure completion)
- Overall Patient Satisfaction(Immediately after IUD procedure completion)
- Provider device satisfaction(Immediately after IUD insertion procedure)
- Reason for IUD procedure(Immediately after IUD insertion procedure)
研究者
Alissa M Conklin
Assistant Professor of Clinical Obstetrics and Gynecology
Indiana University