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

Pre-Eclampsia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03724786
• Other study ID #: 0168-18-WOMC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 2021

Study information

• Verified date: October 2020
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

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.

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Gestational age	Gestational age at delivery	Single evaluation, up to 18 weeks from recruitment
Secondary	Number of patients who underwent a cesarean delivery	Delivery by cesarean surgery	Single evaluation, up to 18 weeks from recruitment
Secondary	Number of patients who underwent labor induction	Need for labor induction, by mechanichal or pharmaceutical means	Single evaluation, up to 18 weeks from recruitment