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The purpose of this research is to collect blood samples and data from pregnant women who are Rh negative. The blood will be used for the future research and the development of non-invasive prenatal tests to identify Rh blood type status of the baby during pregnancy.
This is a prospective multi-center blood collection study. Women 18 years of age or older with a viable singleton pregnancy between12 weeks and 28 weeks gestation will be enrolled.
Whole blood samples will be collected from each enrolled patient. Maternal specimens will be processed to plasma and stored for future testing with non-invasive prenatal tests to identify fetal Rh status.
Baby RhD blood type status will be recorded after delivery. All obstetric clinical management will take place per standard clinic practices and procedures and will not be altered by participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Pregnant women who are RhD negative and between 12 and 28 weeks gestation |
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| Measure | Description | Time Frame |
|---|---|---|
| Fetal RhD determination from maternal whole blood | Collected samples will be used for future development of non-invasive prenatal test to determine fetal RhD status from maternal whole blood | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Women with multiple gestation pregnancy
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Pregnant women who are RhD negative and between 12 and 28 weeks gestation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tasha Kalista Sr. Director, Clinical Affairs | Contact | 8135508310 | tasha.kalista@devyser.us.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Health | Recruiting | New Orleans | Louisiana | 70115 | United States |
We do not plan to share individual participant data with other researchers. Any shared data will be de-identified data at the cohort level in aggregate.
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Human blood specimens will be processed to plasma and stored for future use.