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

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.

Study Overview

• Status: Unknown
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Diagnostic test: Six-hour urine protein collection

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel
    • Edith Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Six-hour urine protein collection; 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.
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Hadas Ganer Herman, MD, Obstetrics and Gynecology, Edith Wolfson Medical Center

Publications and helpful links

General Publications

• Herman HG, Barda G, Miremberg H, Gonen N, Torem M, Kleiner I, Bar J, Weiner E. Management of pregnancies with suspected preeclampsia based on 6-hour vs 24-hour urine protein collection-a randomized double-blind controlled pilot trial. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100429. doi: 10.1016/j.ajogmf.2021.100429. Epub 2021 Jun 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 0168-18-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No