Management of Pregnancies With Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection - a Randomized Double Blind Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-Eclampsia
- Sponsor
- Wolfson Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of participants with an adverse maternal outcome composite
- Last Updated
- 5 years ago
Overview
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.
Investigators
Hadas Ganer Herman
Principal Investigator
Wolfson Medical Center
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
Outcomes
Primary Outcomes
Number of participants with an adverse maternal outcome composite
Time Frame: 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 Outcomes
- Gestational age(Single evaluation, up to 18 weeks from recruitment)
- Number of participants whose neonate had an adverse neonatal outcome composite(Up to 18 weeks)
- Number of patients who underwent a cesarean delivery(Single evaluation, up to 18 weeks from recruitment)
- Number of patients who underwent labor induction(Single evaluation, up to 18 weeks from recruitment)