The Clinical Utility of the Congo-Red Dot Test for Diagnosis and Early Prediction of Preeclampsia During Pregnancy

NCT02455544 | Completed DMC

• 1 other identifier: CRD002
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to validate in a prospective fashion the value of the Congo-Red Dot (CRD) test for diagnosis of preeclampsia. The working hypothesis is that in pregnancies complicated by preeclampsia, will display urine congophilia and have a positive CRD test.

Conditions

Preeclampsia

Keywords

Urine congophilia

Outcome Measures

Primary Outcomes (1)

• Clinical diagnosis of preeclampsia

  Diagnostic utility of the test based on AUC

  20 weeks gestation until 6 weeks postpartum

Study Arms (1)

Pregnant Women

Any pregnant women that is referred to or presents to our tertiary care facility with concern for preeclampsia, will have a Congo Red Dot test preformed by research nurses. The research nurses are not involved in patient management and the results are blinded to the clinical providers and have no impact on clinical diagnosis or patient management.

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study involves testing of urine specimens that originate from pregnant women (ages 18-48) who are presenting for evaluation, following onset of clinical symptoms of preeclampsia. Preeclampsia is a pregnancy specific medical complication of pregnancy and thus selection of specimens only of pregnant women is necessary. The urine specimens from symptomatic women will be used for the testing of the diagnosis value of the CRD test.

You may qualify if:

• Pregnant women evaluated for the onset of clinical symptoms of preeclampsia in the Labor and Delivery Unit of The Ohio State Wexner Medical Center.

You may not qualify if:

• Non-english speaking
• Men
• Prisoners
• Those unable to provide consent for themselves

Sponsors & Collaborators

• Catalin S Buhimschi, MD: lead

Study Sites (1)

The Ohio State Medical Center Labor and Delivery Unit

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

• Buhimschi IA, Zhao G, Funai EF, Harris N, Sasson IE, Bernstein IM, Saade GR, Buhimschi CS. Proteomic profiling of urine identifies specific fragments of SERPINA1 and albumin as biomarkers of preeclampsia. Am J Obstet Gynecol. 2008 Nov;199(5):551.e1-16. doi: 10.1016/j.ajog.2008.07.006.

  PMID: 18984079 BACKGROUND

• Buhimschi IA, Nayeri UA, Zhao G, Shook LL, Pensalfini A, Funai EF, Bernstein IM, Glabe CG, Buhimschi CS. Protein misfolding, congophilia, oligomerization, and defective amyloid processing in preeclampsia. Sci Transl Med. 2014 Jul 16;6(245):245ra92. doi: 10.1126/scitranslmed.3008808.

  PMID: 25031267 BACKGROUND

• Buhimschi IA, Funai EF, et al. Assessment of global protein misfolding load by urine "Congo Red Dot" test for diagnosis and prediction of outcome in women with preeclampsia. Am J Obstet Gynecol 2009; 201(6A): S12.

  BACKGROUND

• Buhimschi CS, Norwitz ER, Funai E, Richman S, Guller S, Lockwood CJ, Buhimschi IA. Urinary angiogenic factors cluster hypertensive disorders and identify women with severe preeclampsia. Am J Obstet Gynecol. 2005 Mar;192(3):734-41. doi: 10.1016/j.ajog.2004.12.052.

  PMID: 15746665 BACKGROUND

• ACOG Committee on Practice Bulletins--Obstetrics. ACOG practice bulletin. Diagnosis and management of preeclampsia and eclampsia. Number 33, January 2002. Obstet Gynecol. 2002 Jan;99(1):159-67. doi: 10.1016/s0029-7844(01)01747-1.

  PMID: 16175681 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine specimens

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Catalin S Buhimschi, MD

  The Ohio State University Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Irina A Buhimschi, MD

  Nationwide Children's Hospital, Center for Perinatal Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Maternal Fetal Medicine Vice-Chair, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 28, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)