Fetal Cells from the maternal circulation for Noninvasive Prenatal Diagnosis Study (FC-NIPD Study), part I
- Conditions
- prenatal diagnosisN/A
- Registration Number
- NL-OMON56395
- Lead Sponsor
- Mitsui Chemicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Pregnant of viable singleton or twin pregnancy at the time of the blood draw
(confirmed and dated by ultrasound);
• At least 18 years of age and able to provide informed consent;
• Pregnancy at the time of blood draw of at least a confirmed gestational age
of 9 weeks 0 days.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Subject is pregnant with more than two fetuses or has had sonographic
evidence of three or more gestational sacs at any time during pregnancy;
• Subject has a fetal demise (including natural or elective reduction)
identified prior to consent;
• Subject has a history of malignancy treated with chemotherapy and/or major
surgery, or bone marrow transplant.
• Subject is positive for any of the infectious tests on hepatitis B, hepatitis
C, syphilis, HIV or HTLV-1.
• Subject has an obvious ectopic gestation.
• Subject is judged as inappropriate by a research rector.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The enumeration of fetal nucleated cells isolated from 10 ml of maternal blood. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Optimization of storage, transport and handling of the blood samples.</p><br>