Preterm Delivery Risk Prediction by Measurement of Prenat... | NCT01009723

Studies
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

NCT01009723

Sponsor

Esoterix Genetic Laboratories, LLC

Status

Unknown status

Last Update Posted

Jun 8, 2012Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Preterm Delivery

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Nov 5, 2009

First Submission Date that Met QC Criteria

Nov 6, 2009

First Posted Date

Nov 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2012

Last Update Posted Date

Jun 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

General population of the US

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Esoterix Genetic Laboratories, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrated Genetics		Westborough	Massachusetts	01581	United States
Integrated Genetics

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12237660	Background	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.
12748511

ID	Term
D047928	Premature Birth
D007752	Obstetric Labor, Premature

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases