Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women

NCT06690099 | Recruiting

• 1 other identifier: DVYUS-RHD-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhesus D Genotype; Pregnancy

Keywords

RhD negative; fetal DNA; cell free fetal DNA; Fetal RhD genotype

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pregnant women

Pregnant women who are RhD negative and between 12 and 28 weeks gestation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who are RhD negative and between 12 and 28 weeks gestation.

You may qualify if:

• Willing and able to provide written informed consent
• 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

You may not qualify if:

• \. Women with multiple gestation pregnancy

Sponsors & Collaborators

• Devyser Inc.: lead

Study Sites (1)

Ochsner Health

New Orleans, Louisiana, 70115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Human blood specimens will be processed to plasma and stored for future use.

Central Study Contacts

Tasha Kalista Sr. Director, Clinical Affairs

CONTACT

8135508310; tasha.kalista@devyser.us.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)