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

Wolfson Medical Center (WMC)

Status: Unknown

Conditions: Pre-Eclampsia

Treatments: Diagnostic Test: Six-hour urine protein collection

Study type: Interventional

Funder types: Other

Identifiers

NCT03724786

0168-18-WOMC

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Calculated collection

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Six-hour urine protein collection

Control collection

No Intervention group

Description:

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.