Maternal Serum Markers Predicting Preeclampsia at Early Gestations
A Case-control Study to Investigate Serum Markers in Predicting Preeclampsia
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PE incidence is 5-8% of all pregnancies in US and worldwide. Morbidity, mortality, and medical legal risks of missing PE often lead to over diagnosis. Currently there is no molecular blood laboratory developed test which can allow serial micro-samplings to assess the PE risk when asymptomatic at home setting along the duration of pregnancy.
The hypothesis is that a blood test can predict PE with a sensitivity higher than 85% and a specificity higher than 80% at early gestation in a PE-Normal cohort.
A single-site retrospective cohort of women who developed PE and women with normal pregnancy will be recruited. Blood samples have been collected from each subject once at the 1st trimester or early 2nd trimester. Delivery and neonatal data have been collected through chart reviews. Two groups (PE and Normal) are matched with age and clinical conditions.
It is an observational study of the accuracy of a diagnostic test on PE prediction. There is only one group of participants. Participants will be tested using a blood test to determine positive or negative. Sensitivity and specificity (Primary outcomes) of the test will be measured at the end of study.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: James Shilling, PhD
- Telefonnummer: 650-427-9198
- E-mail: admin@mprobe.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Having serum collected at a gestational age between 8 and 21 weeks;
Exclusion Criteria:
- Age less than 18
- Preexisting preeclampsia
- Multiple pregnancy or higher order pregnancy
- Missing outcome data of PE, including diagnosis date and PE type
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
PE group
Women with a confirmative diagnosis of PE
|
A blood test is applied to women at the 1st or early 2nd trimester to evaluate risk of developing PE
|
|
Normal pregnancy group
Normal pregnant women
|
A blood test is applied to women at the 1st or early 2nd trimester to evaluate risk of developing PE
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity and specificity
Tidsramme: an average of up to 1 year
|
Sensitivity and specificity of the blood test in classifying PE and normal
|
an average of up to 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity and specificity with the sub-cohorts
Tidsramme: an average of up to 1 year
|
Sensitivity and specificity of the blood test in classifying PE and normal with the sub-cohorts of a) Early-onset PE, b) Late-onset PE, and c) Severe PE
|
an average of up to 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: James Shilling, Ph.D, HBI Solutions Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PE_001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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