Pre-Eclampsia
Conditions
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.
Interventions
DIAGNOSTIC_TESTSix-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.
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Gestational age | Single evaluation, up to 18 weeks from recruitment | Gestational age at delivery |
| 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 |
Countries
Israel
Outcome results
None listed