ClinicalTrials.gg
CompletedNCT01451684Updated Apr 30, 2020

Development of a Non-invasive Prenatal Test

An observational study in Pregnancy, sponsored by Cindy Cisneros. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by Cindy Cisneros · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15,000
Ages
18 Years and older
Sex
Female
01

Study summary

This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Read the detailed description

Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

02

Conditions studied

  • Pregnancy

Keywords

  • pregnancy
  • fetus
  • euploid
03

In context

Lead sponsor

Cindy Cisneros is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will include women who have a healthy pregnancy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
  • Subject is able to provide
  • Subject is ≥ 18 years of age
  • Subject is at least 10 weeks gestation for general enrollment
  • Subject has no known risk factors for chromosomal abnormalities of the fetus
  • Subject has no suspected or confirmed fetal abnormalities

Exclusion criteria

Exclusion Criteria:

  • Subject is pregnant with more than two fetuses
  • Subject is unwilling to undergo a blood draw
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15,000 participants (actual)
06

What researchers measure

Primary outcomes

  1. Absence of chromosomal abnormality

    Time frame: At time of enrollment

07

Study locations

1 site
  • Ariosa Diagnostics
    San Jose, California 95138, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01451684
Lead sponsor
Cindy Cisneros
Responsible party
Cindy Cisneros (CRA, Roche Sequencing Solutions) — Sponsor-investigator
First posted
Oct 14, 2011
Start date
Jun 2011
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Apr 30, 2020

Study contacts

Tracy Roberts
study director · Ariosa Diagnostics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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