Whole Blood Specimen Collection From Pregnant Subjects

Down Syndrome Clinical Trial

Official title:

Whole Blood Specimen Collection From Pregnant Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02430584
• Other study ID #: PRO-101-SAMPLES
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: May 2021

Study information

• Verified date: September 2020
• Source: Progenity, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Description:

This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:

1. be at an increased risk for fetal genetic abnormalities

2. be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy.

3. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (=25 days) clinic visits

• Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive

• Subject is 18 years of age or older

• Subject is at an increased risk for one or more of the following:

• fetal gene and chromosome abnormalities

• congenital fetal infection

• known to possess irregular blood group antigens (subject or father of the baby)

• known to have some other condition amenable to noninvasive prenatal testing

Exclusion Criteria:

• Pregnancy is non-viable

Related Conditions & MeSH terms

• DiGeorge Syndrome
• Down Syndrome
• Edwards Syndrome
• Klinefelter Syndrome
• Patau Syndrome
• Perinatal Infections
• Syndrome
• Turner Syndrome

Intervention

Other:
• Observational - no intervention

Locations

Country	Name	City	State
United States	Regional Obstetrical Consultants	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Progenity, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole blood collection		One or more monthly clinic visits (=25 days apart) over 13 weeks