Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with an adverse maternal outcome composite
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with an adverse maternal outcome composite
时间窗: Up to 18 weeks
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
次要结局
- Gestational age(Single evaluation, up to 18 weeks from recruitment)
- Number of participants whose neonate had an adverse neonatal outcome composite(Up to 18 weeks)
- Number of patients who underwent a cesarean delivery(Single evaluation, up to 18 weeks from recruitment)
- Number of patients who underwent labor induction(Single evaluation, up to 18 weeks from recruitment)
研究者
Hadas Ganer Herman
Principal Investigator
Wolfson Medical Center