prenatal diagnosis N/A
Conditions
Interventions
The collection of 20mL blood at one occasion during the pregnancy. We aim to
combine this blooddraw with other standard of care blood draws that take place
during pregnancy.
Sponsors
Mitsui Chemicals
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The enumeration of fetal nucleated cells isolated from 10 ml of maternal blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimization of storage, transport and handling of the blood samples. | — |
Countries
Netherlands
Outcome results
None listed