Clinical trial NCT03724786: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-10-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of participants with an adverse maternal outcome composite
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Number of participants whose neonate had an adverse neonatal outcome composite
timeFrame: Up to 18 weeks
measure: Gestational age
timeFrame: Single evaluation, up to 18 weeks from recruitment
measure: Number of patients who underwent a cesarean delivery
timeFrame: Single evaluation, up to 18 weeks from recruitment
measure: Number of patients who underwent labor induction
timeFrame: Single evaluation, up to 18 weeks from recruitment
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Obstetrics and Gynecology, Edith Wolfson Medical Center
name: Hadas Ganer Herman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.