Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rhesus D Genotype, Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Fetal RhD determination from maternal whole blood [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- Willing and able to provide written informed consent
- 18 years of age or older at enrollment
- Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age
- Women with RhD negative antigen status by serology
- Willing to provide neonatal ABO and RhD genotyping status
Exclusion criteria
1\. Women with multiple gestation pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ochsner Health — New Orleans
Identifiers
NCT: NCT06690099 · DVYUS-RHD-001