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

Not Applicable

• Conditions: Pre-Eclampsia
• Interventions: Diagnostic Test: Six-hour urine protein collection

• Registration Number: NCT03724786
• Lead Sponsor: Wolfson Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Study Start: 2019-01-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calculated collection	Six-hour urine protein 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.

Primary Outcome Measures

Name	Time	Method
Number of participants with an adverse maternal outcome composite	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel