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Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009723
Recruitment Status : Unknown
Verified June 2012 by Esoterix Genetic Laboratories, LLC.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2009
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
Esoterix Genetic Laboratories, LLC

Brief Summary:
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening in the assessment of patient's risk of preterm delivery.

Condition or disease
Preterm Delivery

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers
Study Start Date : March 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012



Biospecimen Retention:   Samples Without DNA
Serum and plasma samples from the study subjects


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General population of the US
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009723


Locations
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United States, Massachusetts
Integrated Genetics
Westborough, Massachusetts, United States, 01581
United States, New Mexico
Integrated Genetics
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
Esoterix Genetic Laboratories, LLC
Investigators
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Study Director: Medical Monitor Esoterix Genetic Laboratories, LLC
Publications:
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Responsible Party: Esoterix Genetic Laboratories, LLC
ClinicalTrials.gov Identifier: NCT01009723    
Other Study ID Numbers: GGPS0001
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by Esoterix Genetic Laboratories, LLC:
Preterm delivery
preterm labor
maternal-fetal care
maternal serum screening biomarkers
alphafetoprotein
AFP
human chorionic gonadotropin
hCG
unconjugated estriol
Inhibin A
pregnancy associated plasma protein
PAPP-A
maternal screening
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications