Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

June 7, 2012 updated by: Esoterix Genetic Laboratories, LLC

Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Westborough, Massachusetts, United States, 01581
        • Integrated Genetics
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Integrated Genetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

General population of the US

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esoterix Genetic Laboratories, LLC

Investigators

  • Study Director: Medical Monitor, Esoterix Genetic Laboratories, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGPS0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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