Blood collection from RhD-negative pregnant women to develop non-invasive fetal RhD testing
Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
This project collects blood from RhD-negative pregnant women to help develop non-invasive prenatal tests that detect the baby's RhD blood type.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Devyser Inc. Industry-sponsored |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT06690099 on ClinicalTrials.gov |
What this trial studies
This is a prospective multi-center blood collection effort enrolling women 18 years or older with a viable singleton pregnancy between 12 and 28 weeks' gestation who are RhD negative. Whole blood will be drawn, processed to plasma, and stored for future testing aimed at identifying fetal RhD status using cell-free fetal DNA methods. Neonatal RhD status will be recorded after delivery, and clinical care will not be altered by participation. Samples and linked clinical data will be used to support development and validation of non-invasive prenatal RhD genotyping assays.
Who should consider this trial
Good fit: Ideal candidates are RhD-negative pregnant women aged 18 or older with a viable singleton pregnancy between 12 and 28 weeks who can provide informed consent and agree to neonatal RhD genotyping.
Not a fit: Women with multiple gestations or those unwilling/unable to consent or provide neonatal genotyping information are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the collected samples could enable non-invasive prenatal RhD testing that targets anti-D prophylaxis more precisely and reduces unnecessary treatment.
How similar studies have performed: Similar approaches using cell-free fetal DNA to determine fetal RhD have been validated and are already in clinical use in some countries, so the approach is not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. 18 years of age or older at enrollment 3. Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age 4. Women with RhD negative antigen status by serology 5. Willing to provide neonatal ABO and RhD genotyping status Exclusion Criteria: 1\. Women with multiple gestation pregnancy
Where this trial is running
New Orleans, Louisiana
- Ochsner Health — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Tasha Kalista Sr. Director, Clinical Affairs
- Email: tasha.kalista@devyser.us.com
- Phone: 8135508310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.