Management of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection

Study Overview
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Brief Summary
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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.

Official Title
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Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Diagnostic Test: Six-hour urine protein collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calculated collection<br>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. | Diagnostic Test: Six-hour urine protein collection<br>* 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.<br>|
| No Intervention: Control collection<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an adverse maternal outcome composite | 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 | Up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants whose neonate had an adverse neonatal outcome composite | Defined as one of the following neonatal complications - respiratory distress syndrome, necrotizing enterocolitis, mechanichal ventilation, phototherapy, neonatal intensive care unit admission, sepsis, death | Up to 18 weeks | 
| Gestational age | Gestational age at delivery | Single evaluation, up to 18 weeks from recruitment | 
| Number of patients who underwent a cesarean delivery | Delivery by cesarean surgery | Single evaluation, up to 18 weeks from recruitment | 
| Number of patients who underwent labor induction | Need for labor induction, by mechanichal or pharmaceutical means | Single evaluation, up to 18 weeks from recruitment |