Clinical trial NCT01009723: Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
Official title: Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Delivery
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
Lead sponsor: Esoterix Genetic Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population of the US

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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Westborough
country: United States
facility: Integrated Genetics
state: Massachusetts
city: Santa Fe
country: United States
facility: Integrated Genetics
state: New Mexico
Study officials:
affiliation: Esoterix Genetic Laboratories, LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.