Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Urine b-hCG
研究概览
简要总结
The goal of this pilot study is to assess the accuracy and precision of an at-home quantitative urine beta hCG (b-hCG) test in the management of pregnancy of unknown location (PUL).
详细描述
This study proposes to test the ability of the Mira urine hCG testing kit to accurately and precisely quantify urine beta hCG testing in women with PUL, thus preventing unnecessary travel time to medical care, time lost from work, costs of childcare services, anxiety, and lack of adherence to medical recommendations.
Aim 1: Assess the accuracy and precision of an at-home quantitative urine b-hCG test in the management of pregnancy of unknown location (PUL). Hypothesis: The Mira quantitative home urine pregnancy test will accurately and precisely quantify beta hCG levels in patients with PUL.
Approach: The study team will recruit 30 women with a diagnosed pregnancy of unknown location (cases) and non-pregnant 5 controls. Potential participants may be identified in the emergency department (ED), inpatient floor, or University of Colorado Health (UC Health) or School of Medicine (CU Medicine) outpatient clinics. Once a diagnosis of PUL is established, cases will be provided with a Mira home testing device.
Cases will begin performing urine and serum hCG testing 24 hours after the initial hCG level. Urine hCG testing will be performed on the first morning urine at home and participants will limit water for at least 8 hours before testing. Serum hCG testing will occur at a UCHealth laboratory before 10 am and within 2 hours of the urine test to allow for the comparison of the values. Both urine and serum hCG testing will then occur daily x 7 days, or until a medical or surgical intervention is indicated. If serum testing is indicated on a weekend, patients will present to the UCH Infusion Center.
Non-pregnant controls will test the first morning urine at home and undergo serum hCG testing in a UCHealth lab on the 4th and 6th day of the menstrual cycle. All urine hCG values will be recorded in the Mira home kit and evaluated in comparison to serum hCG levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for controls:
- •Non-pregnant
- •Inclusion Criteria for cases:
- •Diagnosed with PUL requiring ongoing surveillance of serum hCG levels
排除标准
- •for controls:
- •History of renal disease
- •History of type I or type II diabetes
- •Known malignancy of any diagnosis including hCG-secreting tumors (hepatobiliary tumors and neuroendocrine tumors) and ovarian germ cell tumors.
- •Gestational Trophoblastic Disease
- •Use of hormonal contraception within last 3 months
- •Patients who work the night shift
- •Exclusion Criteria for cases:
- •History of renal disease
- •History of type I or type II diabetes
- •Known malignancy of any diagnosis including hCG-secreting tumors (hepatobiliary tumors and neuroendocrine tumors) and ovarian germ cell tumors.
- •Gestational Trophoblastic Disease
- •Unstable patient, concern for ruptured ectopic pregnancy
- •Initial serum hCG level > 100,000 mIU/ml
结局指标
主要结局
Urine b-hCG
时间窗: 7 days
Cases will begin performing urine and serum hCG testing 24 hours after the initial hCG level. Urine hCG testing will be performed on the first morning urine at home and participants will limit water for at least 8 hours before testing. Serum hCG testing will occur at a UCHealth laboratory before 10 am and within 2 hours of the urine test to allow for the comparison of the values. Both urine and serum hCG testing will then occur daily x 7 days, or until a medical or surgical intervention is indicated. If serum testing is indicated on a weekend, patients will present to the UCH Infusion Center. Non-pregnant controls will test the first morning urine at home and undergo serum hCG testing in a UCHealth lab on the 4th and 6th day of the menstrual cycle. All urine hCG values will be recorded in the Mira home kit and evaluated in comparison to serum hCG levels.
Serum b-hCG
时间窗: 7 days
Cases will begin performing urine and serum hCG testing 24 hours after the initial hCG level. Urine hCG testing will be performed on the first morning urine at home and participants will limit water for at least 8 hours before testing. Serum hCG testing will occur at a UCHealth laboratory before 10 am and within 2 hours of the urine test to allow for the comparison of the values. Both urine and serum hCG testing will then occur daily x 7 days, or until a medical or surgical intervention is indicated. If serum testing is indicated on a weekend, patients will present to the UCH Infusion Center. Non-pregnant controls will test the first morning urine at home and undergo serum hCG testing in a UCHealth lab on the 4th and 6th day of the menstrual cycle. All urine hCG values will be recorded in the Mira home kit and evaluated in comparison to serum hCG levels.
次要结局
未报告次要终点