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Preterm DeliveryNCT01009723

Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

An observational study of Preterm Delivery, run by Esoterix Genetic Laboratories, LLC at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Preterm Delivery
How many people
2,000 participants
Where
2 sitesUnited States
Study dates
Mar 2010to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: General population of the US

Who may be able to join

  • 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.

Who cannot join

  • N/A

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Integrated Genetics

    Santa Fe, New Mexico, 87505

  • Integrated Genetics

    Westborough, Massachusetts, 01581

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
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
Medical subject headings
Premature Birth, Obstetric Labor, Premature

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionJul 2012 (estimated)
  4. Study completionJul 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009723
Sponsor's protocol ID
GGPS0001
Status last verified
Jun 2012
First submitted
5 Nov 2009
Last updated
8 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12237660

  • 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.

    PubMed 12748511

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Delivery, run by Esoterix Genetic Laboratories, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009723, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.

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