Status:

COMPLETED

Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification

Lead Sponsor:

Cedars-Sinai Medical Center

Collaborating Sponsors:

ThermoFisher Scientific Brahms Biomarkers France

Conditions:

Preeclampsia and Eclampsia

Preeclampsia Severe

Eligibility:

FEMALE

18+ years

Brief Summary

The purpose of this study is to 1. Identify a cut-off for the ratio of the serum proteins soluble FMS-like Tyrosine Kinase 1 (sFLT-1) and placental growth factor (PlGF) that identifies women will who...

Detailed Description

Preeclampsia is a leading cause of maternal and fetal morbidity and mortality in the US, and affects about 5% of pregnancies. Despite its morbidity, preeclampsia is challenging to distinguish from wor...

Eligibility Criteria

Inclusion

  • Signed informed consent in a pregnant woman ≥ 18 years of age.
  • Gestational age 23+0 to 34+6/7 weeks
  • Singleton pregnancy
  • Hospitalized with (or develop while hospitalized) a hypertensive disorder of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia or gestational hypertension) as defined by ACOG guidelines.

Exclusion

  • 1\. Patients who have received intravenous heparin within 24 hours of enrollment. Low dose subcutaneous heparin or low molecular weight heparin (LMWH) for prophylaxis of deep venous thrombosis (DVT) is permitted.
  • Patients who are currently participating in another clinical trial to evaluate a new therapeutic intervention or who have participated in another such trial in the previous 30 days.
  • Multiple gestations.

Key Trial Info

Start Date :

December 20 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2022

Estimated Enrollment :

1050 Patients enrolled

Trial Details

Trial ID

NCT03815110

Start Date

December 20 2018

End Date

October 1 2022

Last Update

November 28 2022

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

2

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States, 92123

3

UC San Francisco Medical Center

San Francisco, California, United States, 94158

4

Torrance Memorial Medical Center

Torrance, California, United States, 90505