Comparison of Random Spot Urine Protein:Creatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants diagnosed with preeclampsia with the protein:creatinine ratio test
研究概览
简要总结
This is a non-inferiority, prospective study of the relationship between the 24-hour urine protein collection and spot protein:creatinine ratio in the diagnosis of preeclampsia involving a sample of 18-45 year-old pregnant women attending the new Obstetrics orientation. The investigators will follow all participants who consent to be part of this study throughout their entire pregnancy. Those who get evaluated for preeclampsia will then have a P:C ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine collection (standard of care). Those participants who are not evaluated for preeclampsia during their pregnancy will be dropped from the study.
Participants evaluated for preeclampsia during the prenatal period will be asked to provide a random spot clean-catch urine sample at intervals of approximately 0 and 24 hours following the initiation of the 24-hour urine collection. The patient's demographic and clinical data, as well as the spot protein:creatinine ratio and 24-hour urine protein will be collected and analyzed at the conclusion of the study period.
详细描述
The investigators will recruit a total of 12,000 pregnant female subjects ages 18-45 that have a confirmed positive pregnancy test and whom are attending the new Obstetrics Orientation class. Subjects will be recruited from the MOFH and Eglin.
Visit 1:
- Obtain signed Informed Consent document and HIPAA Authorization (research-driven)
- Review Medical History and record patients age, gestational age, parity and presence of high-risk antepartum conditions (i.e. chronic hypertension, gestational diabetes mellitus-all classes, and pre-existing renal disease) (standard of care)
All participants who consent to be part of this study will be followed throughout their entire pregnancy (birth of child). Those who are identified by their primary obstetrics provider as potentially having preeclampsia will then have a P:C Ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine collection (see Antepartum Visit Schedule Below). Those participants who are not evaluated for preeclampsia during their pregnancy will be dropped from the study at the end of their pregnancy (birth of child).
Antepartum Visit:
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tricare beneficiaries receiving care at Nellis AFB
- •Pregnant women (Active Duty Military or DoD beneficiaries) ages 18-45
排除标准
- 未提供
结局指标
主要结局
Number of participants diagnosed with preeclampsia with the protein:creatinine ratio test
时间窗: 24 months
次要结局
未报告次要终点