Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Interexaminer Agreement
研究概览
简要总结
Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.
详细描述
The trial seeks to compare the DilaCheck device with standard digital cervical dilation examinations. 50 laboring female participants will be enrolled with 25 randomly assigned to the control arm and 25 to the treatment (DilaCheck) arm. Each participant will receive two cervical dilation examinations from two separate physicians. The main outcome measure is agreement between the two cervical dilation measurements. Secondary outcomes include ease of use of the device and pain levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
Masking is not possible since physicians and participants will know whether they are using the device or not.
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
- •The research population is pregnant women in the first stage of labor. Subjects eligible for inclusion in the study must be: pregnant women who are admitted to a Labor and Delivery unit for management or induction of labor in the first stage of labor, are able to give informed consent, are 18 years of age or greater, speak English, and have a gestational age greater than or equal to 37 weeks (i.e. term pregnancy). Patients are only consented if they have adequate pain control, either because they are not yet in labor (i.e. are admitted for an induction of labor) or have a functioning epidural.
排除标准
- •Exclusion criteria include progression to the second stage of labor (i.e. known dilation of ten centimeters), known rupture of membranes, any condition that renders labor unsafe for the patient (e.g. cardiac conditions, pulmonary hypertension) and any other condition that necessitates an emergent or urgent cesarean section (e.g. non-reassuring fetal status, placental abruption, hemorrhage, cord prolapse). All participants are necessarily female due to the subject matter. Given the vulnerability of pregnant patients under the age of 18, this study will exclude children. There are no restrictions on eligibility based on race or ethnicity.
研究组 & 干预措施
Standard Dilation Exam
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
干预措施: Cervical dilation examination (Diagnostic Test)
Dilation Exam with DilaCheck
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
干预措施: DilaCheck (Device)
结局指标
主要结局
Interexaminer Agreement
时间窗: Immediate upon examination
Agreement between 2 cervical dilation measurements taken by 2 different physicians. If the measurements are the same, the outcome is "agree." If the measurements are different, the outcome is "disagree."
次要结局
- Pain With Examination(Immediate within 5 minutes of examinations)
- Ease of Use(Upon conclusion of the trial, <3 months from time of last examination with device)