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

NCT03724786 | Unknown

• 1 other identifier: 0168-18-WOMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants whose neonate had an adverse neonatal outcome composite

  Up to 18 weeks

• Gestational age

  Single evaluation, up to 18 weeks from recruitment

• 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

Study Arms (2)

Calculated collection

EXPERIMENTAL

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.

Diagnostic Test: Six-hour urine protein collection

Control collection

NO INTERVENTION

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.

Interventions

Six-hour urine protein collection 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.

Calculated collection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Edith Wolfson Medical Center

Holon, Israel

Location

Related Publications (1)

• 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.

  PMID: 34182189 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hadas Ganer Herman, MD

  Obstetrics and Gynecology, Edith Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: January 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)