- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01009723
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The study will investigate whether the levels of individual maternal serum screening biomarkers, their combinations or temporal changes in the level can be associated with an increased risk of preterm delivery. Blood samples at three time points in pregnancy will be collected from the study participants. The first two blood draws will be timed to coincide with the first and second trimester maternal serum testing. The third blood draw will coincide with the screening for gestational diabetes. Pregnancy outcome information will be collected from the physicians and linked to the subject samples.
Subject samples from a case-control patient group will be analyzed by the serum screening biochemical assay. Statistical analyses will be performed to achieve the study objectives.
NOTE: This study is recruiting in Florida, USA. The laboratory data coordination is being performed in Massachusetts, USA and New Mexico, USA. New study locations will be identified on an ongoing basis.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Massachusetts
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Westborough, Massachusetts, Forenede Stater, 01581
- Integrated Genetics
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New Mexico
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Santa Fe, New Mexico, Forenede Stater, 87505
- Integrated Genetics
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of the English language.
- The participant consents to and signs the approved consent form.
- The participant is 18 years of age or older.
- The participant has a singleton pregnancy.
- The participant is planning on continuing the pregnancy.
- The participant has intent to clinically test for Down syndrome risk.
- The participant consents to the study at the first trimester of her pregnancy.
- The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of either the English or Spanish language.
Exclusion Criteria:
- N/A
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Medical Monitor, Esoterix Genetic Laboratories, LLC
Publikationer og nyttige links
Generelle publikationer
- Chitayat D, Farrell SA, Huang T, Meier C, Wyatt PR, Summers AM. Double-positive maternal serum screening results for down syndrome and open neural tube defects: An indicator for fetal structural or chromosomal abnormalities and adverse obstetric outcomes. Am J Obstet Gynecol. 2002 Sep;187(3):758-63. doi: 10.1067/mob.2002.125240.
- Lepage N, Chitayat D, Kingdom J, Huang T. Association between second-trimester isolated high maternal serum maternal serum human chorionic gonadotropin levels and obstetric complications in singleton and twin pregnancies. Am J Obstet Gynecol. 2003 May;188(5):1354-9. doi: 10.1067/mob.2003.278.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GGPS0001
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