Management of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection
2020年10月6日 更新者：Hadas Ganer Herman、Wolfson Medical Center
Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study
In this trial - the investigators plan to study the efficacy of pregnancy management in cases of suspcted preeclampsia, based on a 6-hour urine collection for protein, as compared to the standard 24-hour collection.
For participants hospitalized at the maternal fetal unit at our institution, one sample of urine collected over 6 hours will be analyzed, and a second one following an additional 18 hours.
Participants will be blinded to the urine collection result used to manage their pregnancy (actual 24 hour collection versus calculated 24-hour collection), as will be their attending physicians.
An external physician will compare the two urine collection results, and in case only one is pathological (>300 mg), will notify the research team and the attending physician.
研究概览
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Holon、以色列
- Edith Wolfson Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Patients referred to the Edith Wolfson Medical Center for suspected preeclampsia, for whom hospitalization was recommended for urine collection for protein and blood pressure follow up
- Gestational age >24+0 weeks and < 42+0 weeks
- Consent to participation
Exclusion Criteria:
- Patients with features of severe preeclampsia at presentation - blood pressure >160/110, headache, blurred vision, right upper quadrant pain, liver transaminase abnormality, increased creatinine level, thrombocytopenia.
- Patients whom were decided to be delivered (regardless of protein collection)
- Multiple gestation
- Chronic hypertension
- Pre-gestational diabetes mellitus
- Thrombophilia (APLA)
- Intrauterine growth retardation
- Lack of prenatal care
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Calculated collection
Patients in this arm will collect urine for protein for 6 hours, and then an additional 18 hours.
The result of the 6-hour collection will be multiplied by four, and the result will serve as the "calculated collection", for pregnancy management.
The additional 18 hour collection will serve for: 1. Patient blinding.
2. Calculation of the total 24-hour protein collection for reference.
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This intervention includes the analysis of a 6-hour urine collection for protein, to serve for a calculated 24-hour result, according to which pregnancy will be managed.
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无干预：Control collection
Patients in this arm will collect urine for protein for 6 hours, and then an additional 18 hours.
The result of the total 24-hour collection will serve for pregnancy management.
The initial 6-hour collection will serve for patient blinding.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with an adverse maternal outcome composite
大体时间：Up to 18 weeks
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Defined as one of the following maternal complications - hepatic or renal injury, placental abruption, eclampsia, thrombocytopenia, cerebral morbidity, respiratory morbidity, blood pressure > 160/110, need for anti-hypertensives
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Up to 18 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants whose neonate had an adverse neonatal outcome composite
大体时间：Up to 18 weeks
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Defined as one of the following neonatal complications - respiratory distress syndrome, necrotizing enterocolitis, mechanichal ventilation, phototherapy, neonatal intensive care unit admission, sepsis, death
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Up to 18 weeks
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Gestational age
大体时间：Single evaluation, up to 18 weeks from recruitment
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Gestational age at delivery
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Single evaluation, up to 18 weeks from recruitment
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Number of patients who underwent a cesarean delivery
大体时间：Single evaluation, up to 18 weeks from recruitment
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Delivery by cesarean surgery
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Single evaluation, up to 18 weeks from recruitment
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Number of patients who underwent labor induction
大体时间：Single evaluation, up to 18 weeks from recruitment
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Need for labor induction, by mechanichal or pharmaceutical means
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Single evaluation, up to 18 weeks from recruitment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hadas Ganer Herman, MD、Obstetrics and Gynecology, Edith Wolfson Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月1日
初级完成 (预期的)
2021年7月1日
研究完成 (预期的)
2021年7月1日
研究注册日期
首次提交
2018年10月29日
首先提交符合 QC 标准的
2018年10月29日
首次发布 (实际的)
2018年10月30日
研究记录更新
最后更新发布 (实际的)
2020年10月8日
上次提交的符合 QC 标准的更新
2020年10月6日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.