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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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