Back to resultsManagement of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection
Primary Purpose
Pre-Eclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Six-hour urine protein collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Pre-Eclampsia
Eligibility Criteria
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
Sites / Locations
- Edith Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Calculated collection
Control collection
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Gestational age
Gestational age at delivery
Number of patients who underwent a cesarean delivery
Delivery by cesarean surgery
Number of patients who underwent labor induction
Need for labor induction, by mechanichal or pharmaceutical means
Full Information
NCT ID
NCT03724786
First Posted
October 29, 2018
Last Updated
October 6, 2020
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03724786
Brief Title
Management of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection
Official Title
Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calculated collection
Arm Type
Experimental
Arm 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.
Arm Title
Control collection
Arm Type
No Intervention
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Six-hour urine protein collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with an adverse maternal outcome composite
Description
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
Time Frame
Up to 18 weeks
Secondary Outcome Measure Information:
Title
Number of participants whose neonate had an adverse neonatal outcome composite
Description
Defined as one of the following neonatal complications - respiratory distress syndrome, necrotizing enterocolitis, mechanichal ventilation, phototherapy, neonatal intensive care unit admission, sepsis, death
Time Frame
Up to 18 weeks
Title
Gestational age
Description
Gestational age at delivery
Time Frame
Single evaluation, up to 18 weeks from recruitment
Title
Number of patients who underwent a cesarean delivery
Description
Delivery by cesarean surgery
Time Frame
Single evaluation, up to 18 weeks from recruitment
Title
Number of patients who underwent labor induction
Description
Need for labor induction, by mechanichal or pharmaceutical means
Time Frame
Single evaluation, up to 18 weeks from recruitment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadas Ganer Herman, MD
Organizational Affiliation
Obstetrics and Gynecology, Edith Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Wolfson Medical Center
City
Holon
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34182189
Citation
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.
Results Reference
derived
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Management of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection
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