Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 122
- 主要终点
- sensitivity
研究概览
简要总结
The goal of this study is to learn if the ROM-Plus bedside test can effectively triage patients who present with pregnancy of unknown location (PUL) and vaginal bleeding as high or low risk for ectopic pregnancy. The main question to answer is:
Can the ROM-Plus bedside test effectively risk-stratify patients who present with PUL and vaginal bleeding as high or low risk for ectopic pregnancy after a single clinical encounter.
Participants will have a vaginal swab collected at the time of presentation.
详细描述
Pregnancy of unknown location (PUL) is a clinical scenario in which a patient has cramping or vaginal bleeding and is known to be pregnant based on physical and laboratory evaluations, but an intrauterine or extrauterine pregnancy cannot be visualized on ultrasound examination. At present, follow-up for these patients includes multiple blood draws and repeat ultrasounds to confirm if the pregnancy is inside the uterus or in a riskier location outside the uterus (ectopic pregnancy); however, most of these patients will be low-risk for ectopic pregnancy and do not need intensive follow-up. This study aims to improve the risk-stratification of PUL patients after a single encounter to allow for patients at low-risk for ectopic pregnancy to be discharged from intensive follow-up.
Recruitment: Up to 120 participants will be recruited for this study
Entry Criteria:
- PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- Vaginal bleeding
- Clinically stable
- English-speaking
Consent - Eligible Patients will be invited to participate by a member of the clinical care team. Written consent will be required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- •Vaginal bleeding
- •Clinically stable
- •English-speaking
排除标准
- 未提供
研究组 & 干预措施
Pregnancy of unknown location
Pregnancy of unknown location with vaginal bleeding
干预措施: ROM-Plus bedside test (Diagnostic Test)
结局指标
主要结局
sensitivity
时间窗: at time of enrollment
Sensitivity of ROM-Plus test
次要结局
- specificity(at time of enrollment)
- Positive predictive value(at the time of enrollment)
- Negative predictive value(at the time of enrollment)