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

NCT ID: NCT03724786

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-07-31

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.

Conditions

Pre-Eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Calculated collection

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.

Group Type: EXPERIMENTAL

Six-hour urine protein collection

Intervention Type: DIAGNOSTIC_TEST

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.

Control collection

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hadas Ganer Herman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadas Ganer Herman, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology, Edith Wolfson Medical Center

Locations

Edith Wolfson Medical Center

Holon, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 34182189 (View on PubMed)

Other Identifiers

0168-18-WOMC

Identifier Type: -

Identifier Source: org_study_id